tag:blogger.com,1999:blog-58614721104156434952024-02-19T06:54:16.756+02:00Pharmaceutical Market Access in CEE / CIS / AsiaAnonymoushttp://www.blogger.com/profile/13600596456916039751noreply@blogger.comBlogger353125tag:blogger.com,1999:blog-5861472110415643495.post-36922440787886738602018-01-17T13:11:00.000+02:002018-01-17T13:11:31.681+02:00Georgia Pharmaceutical & Healthcare Industries Overview 2017<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLF9JXzwjw9wVAMTnA-imjsRUknOdEfYWqsvsTdysoXSH6OmE1jC-XTcJCjLWSg8sTPBNnY_X80S0VTV2i9-csc2opu0KXw8zPiUwH_WamspnPoCDw8fhanPA9NXmRvVyHl9_4oAM9L6Z/s1600/GEO_page+1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="909" data-original-width="639" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLF9JXzwjw9wVAMTnA-imjsRUknOdEfYWqsvsTdysoXSH6OmE1jC-XTcJCjLWSg8sTPBNnY_X80S0VTV2i9-csc2opu0KXw8zPiUwH_WamspnPoCDw8fhanPA9NXmRvVyHl9_4oAM9L6Z/s640/GEO_page+1.jpg" width="449" /></a></div>
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<br />
"Georgia Pharmaceutical & Healthcare Industries Overview 2017" report was rolled-out. This report demonstrates Georgian economic, pharmaceutical and healthcare latest trends in a tailored made systematic and business styled manner. The Overview is intended for decision makers, industry professionals, and other stakeholders globally. It covers 2012-1HY 2017 historical data with the forecast of the economics and pharmaceutical market forecast to 2017-2019.<br />
<br />
<div style="text-align: center;">
<a href="https://goo.gl/mUVEWA" target="_blank">More details</a></div>
<br />
<h3 style="text-align: left;">
REPORT SCOPE</h3>
Georgia Pharmaceutical & Healthcare Industries Overview 2017 provides essential information on the economics, pharmaceutical market, and healthcare landscape in the country, and comprises the following:<br />
<div style="text-align: left;">
</div>
<ol>
<li>The Overview of the key macroeconomic indicators of the Georgian economics in 2016-2017, local currency exchange dynamics, country progress in 2016, and the outlook to 2017-2018;</li>
<li>Analysis of sales in the Georgian pharmaceutical market in 2012-2016, pricing analysis;</li>
<li>TOP-20 pharmaceutical companies in Georgia in 2016-1HY 2017;</li>
<li>TOP-20 trade names in Georgian pharmaceutical market in 2016-1HY 2017;</li>
<li>TOP-20 ATC-2 classes on the Georgian pharmaceutical market in 2016-1HY 2017;</li>
<li>Weighted average cost of a pack of a pharmaceutical product in Georgia in 2016-1HY 2017;</li>
<li>NEW! Forecast of total pharmaceutical market sales in Georgia for 2017-2019;</li>
<li>PESTLE impact and SWOT analyses of the local pharmaceutical market in 2016-2017;</li>
<li>NEW! Distribution of physicians by main specializations and regions of Georgia;</li>
<li>Regulatory environment of the pharmaceutical industry of Georgia;</li>
<li>Healthcare system analysis, epidemiology and demographics of Georgia in 2015-2016.</li>
</ol>
<br />
<ol style="text-align: left;">
</ol>
<h3 style="text-align: left;">
REASONS TO BUY THE OVERVIEW</h3>
The Overview will upgrade your vision of the Georgian pharmaceutical and healthcare environments by making you possible to:<br />
<div style="text-align: left;">
</div>
<ol>
<li>Understand the Georgian pharmaceutical market from the helicopter point of view;</li>
<li>Develop the marketing plan for your products in Georgia;</li>
<li>Assess market and revenues opportunities in the Georgian pharmaceutical market;</li>
<li>Elaborate and initiate the market entry process of the pharmaceutical product in Georgia.</li>
</ol>
<br />
<ol style="text-align: left;">
</ol>
<h3 style="text-align: left;">
GEORGIAN ECONOMY SUMMARY</h3>
(Report Excerpts)<br />
<br />
This article is based on the "Georgia Pharmaceutical and Healthcare Industries Overview 2017" report developed by UPharma Consulting and contains short excerpts from this report The full report is available for purchase now.<br />
<br />
<h4 style="text-align: left;">
Georgia in 1990s-2015</h4>
Georgia is located in the South Caucasus region at the crossroads of Southwest Asia and Southeastern Europe. In 2016, Georgia was 119th country in the world by GDP (US$ 14.2 bn). GDP per capita amounted US$ 10,044 (105th position in the world rating).<br />
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Since 1995, the Georgian economy took the path of gradual recovering. The GDP grew 2.4% in 1995 and 14% in 1996, which stimulated the development of small and medium business in the country. About 30 ths new private enterprises were registered those years. At the same time the financial support from International organizations contributed to the growth of the State debt, which remains high till now.<br />
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In 2003, the peaceful Rose Revolution led to that the new pro-Western government headed by Mikheil Saakashvili came to power in Georgia. The new government implemented broad and comprehensive reforms, which were aimed to economy liberalization, de-bureaucratization and privatization of the State property.<br />
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Establishment of an attractive business environment led to a significant inflow of Foreign Direct Investment in the country, facilitating high economic growth rates. Herewith, the living standards of the population and its purchasing power did not change significantly.<br />
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<h4 style="text-align: left;">
Georgia in 2016</h4>
In 2015 and 2016 the GDP growth slowed to 2.9% and 2.7%, respectively, after the notable fall in exports (23% y-o-y in 2015) due to slowdown of some of the key trade partners (Russia, Azerbaijan, Ukraine). Consumer and business confidence were affected by domestic political uncertainty. The average level of inflation reached 2.1% in 2016; however, it grew faster by the end of the year which was mainly due to the increasing amount of GEL in circulation and its depreciation.<br />
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<iframe allowfullscreen="allowfullscreen" frameborder="0" height="667" scrolling="no" src="https://e.infogram.com/619ee64a-e73e-48e1-bab1-9510425a9540?src=embed" style="border: none;" title="GEO 2017: Graph 1" width="600"></iframe><br />
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<a href="https://infogram.com/619ee64a-e73e-48e1-bab1-9510425a9540" style="color: #989898!important; text-decoration: none!important;" target="_blank">GEO 2017: Graph 1</a><br />
<a href="https://infogram.com/" rel="nofollow" style="color: #989898!important; text-decoration: none!important;" target="_blank">Infogram</a></div>
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Georgia is experiencing an economic recovery in 2017 on the back of stronger growth in the United States, Europe, and Russia. Similarly, remittances recovered significantly (by 20% y-o-y), with a positive impact on the non-tradable sectors. Pulled by the resulting boost in domestic demand and net exports, real GDP grew by 4.9% y-o-y in 1H2017.<br />
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Exports rose by 30% in 1H2017. Meanwhile, imports rose by 8.8% as growth quickened and remittances surged by 19.7% y-o-y. Higher tourism receipts strongly boosted service exports.<br />
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In 2016, private consumption rose 2.8% y-o-y to GEL 21.3 bn. In 1Q2017, private consumption showed 12% growth vs 1Q2016. The growth was enabled by higher remittances and accommodative monetary policy during 2016.<br />
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<h3 style="text-align: left;">
PHARMACEUTICAL MARKET OF GEORGIA</h3>
In 1990s, pharmaceutical market of Georgia was hugely dependent on imports, while retail sale was controlled by three major pharmacy chains. At the same time the accessibility oа drugs was very low due to low incomes of the population and high cost of imported products.<br />
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The import license was abolished, the import procedure was simplified, the physical and technical requirements for creating a pharmacy business were noticeably relaxed. Importers were not obliged to register their drugs in Georgia if they were approved by the FDA and EMA. Furthermore, in 2009 the government endorsed the parallel import of drugs, allowing to import drugs from any country in any package with no special document needed. Consequently, the prices of pharmaceuticals notably decreased, while the sales of pharmaceuticals grew 6 times from 2004 to 2014.<br />
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According to the GeoStat, in 2016 there were 68 producers of pharmaceuticals in Georgia, 295 wholesalers, and 1,014 retailers. The major players on the market are three vertically integrated companies, which include both production, distribution and retail departments. PSP, Aversi and Georgian Healthcare Group (GHG) companies obtain about a considerable share of the distribution and retail markets and are able to regulate prices on them.<br />
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<iframe allowfullscreen="" frameborder="0" height="800" msallowfullscreen="" src="https://app.box.com/embed/s/hg6nt0h5ll65k98wq8iv75nnwyub5ir9" webkitallowfullscreen="" width="600"></iframe>
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<h3>
<br />PHARMACEUTICAL MARKET FORECAST 2017-2019</h3>
In recent years, foreign companies started considering Azerbaijan not only as a market but also as a prospective place for deployment of production facilities and a hub for accessing the pharmaceutical markets of neighbouring republics, including Iran. The government’s favour should promote the development of local pharmaceutical industry in following years. The development of the Pirallahy industrial park is supposed to boost the market, but first new productions are expected to be launched only in 2019.<br />
<br />
Source: <a href="https://www.upharma-c.com/en/news/178-azerbaijan-pharma-and-healthcare-industries-overview-2017/" target="_blank">UPharma Consulting</a></div>
Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comGeorgia42.315407 43.35689200000001639.31008 38.193318000000019 45.320734 48.520466000000013tag:blogger.com,1999:blog-5861472110415643495.post-74871753159925212272017-11-17T14:29:00.001+02:002017-11-17T14:29:15.233+02:00Uzbekistan to Open a Chain of Social Pharmacies<div dir="ltr" style="text-align: left;" trbidi="on">
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The Ministry of Health of the Republic, the State Unitary Enterprise O'zmedimpeks, the Council of Ministers of the Republic of Karakalpakstan, the khokimiyats of the regions and the city of Tashkent, until January 1, 2018, are instructed to approve the dislocation of social pharmacies on the basis of state health institutions (district (city) medical associations, rural family clinics, rural medical stations). <br /><br />This follows from the Decree of the President of the Republic of Shavakt Mirziyoyev on November 7, 2017. <br /><br /><blockquote class="tr_bq">
Their functioning should be provided by December 1, 2018. </blockquote>
<br />The necessary funds for equipping social pharmacies will be sent from the non-budgetary Fund for the Development of the Material and Technical Base of Educational and Medical Institutions. The local budget will finance overhaul, as well as engineering infrastructure, landscaping and development of project documentation for pharmacies. <br /><br />The Ministry of Health and the State Committee of Uzbekistan for the promotion of privatized enterprises and the development of competition are called upon to provide, under the orders of "O'zmedimpeks" SUE, the granting of premises and other property of state property for free use, including for the creation of social pharmacies.<div>
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Source: <a href="http://www.ut.uz/en/healthcare/a-network-of-social-pharmacies-will-be-opened-in-uzbekistan/" target="_blank">UZ</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUzbekistan41.377491 64.58526200000005729.199661499999998 43.930965000000057 53.5553205 85.239559000000057tag:blogger.com,1999:blog-5861472110415643495.post-80444088276985903242017-11-12T20:42:00.000+02:002017-11-12T20:42:44.554+02:00Azerbaijan Pharmaceutical & Healthcare Industries Report 2017<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg50yxtk8-QGhBAnGPqDR2qu71lHrtOWYEbW2o2s6WNkUvK92CclAYb2vMqn38t_l4fF9Bz2oHgy82lk5dxYcWdPrCI9MXCBho3Cp_ssio6ma1lvf6rN6TgfIAg9IZQ7D_v3j8wyFkv-Enz/s1600/AZE.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="906" data-original-width="636" height="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg50yxtk8-QGhBAnGPqDR2qu71lHrtOWYEbW2o2s6WNkUvK92CclAYb2vMqn38t_l4fF9Bz2oHgy82lk5dxYcWdPrCI9MXCBho3Cp_ssio6ma1lvf6rN6TgfIAg9IZQ7D_v3j8wyFkv-Enz/s640/AZE.jpg" width="448" /></a></div>
<br />
The Overview uncovers economic, pharmaceutical and healthcare insights in a tailored made systematic and business styled manner. This report is intended for decision makers, industry professionals, and other stakeholders globally. The report covers 2012-1HY 2017 historical data with the forecast of the economics and pharmaceutical market forecast to 2017-2019.<br />
<br />
<div style="text-align: center;">
<a href="https://www.upharma-c.com/en/news/178-azerbaijan-pharma-and-healthcare-industries-overview-2017/" target="_blank">More details</a></div>
<br />
<h3 style="text-align: left;">
REPORT SCOPE</h3>
Azerbaijan Pharmaceutical & Healthcare Industries Overview 2017 provides essential information on the economics, pharmaceutical market, and healthcare landscape in Azerbaijan, and comprises the following:<br />
<ol style="text-align: left;">
<li>The Overview of the key macroeconomic indicators of the Azerbaijani economics in 2016-2017, local currency exchange dynamics, country progress in 2016, and the outlook to 2017-2018;</li>
<li>Analysis of sales in the Azerbaijani pharmaceutical market in 2012-2016, pricing analysis;</li>
<li>TOP-20 pharmaceutical companies in the Azerbaijan market in 2016-1HY 2017;</li>
<li>TOP-20 trade names on the Azerbaijan pharmaceutical market in 2016-1HY 2017;</li>
<li>TOP-20 ATC-2 classes on the Azerbaijan pharmaceutical market in 2016-1HY 2017;</li>
<li>Weighted average cost of a pack of a pharmaceutical product in Azerbaijan in 2016-1HY 2017;</li>
<li>NEW! Forecast of total pharmaceutical market sales in Azerbaijan in 2017-2019;</li>
<li>PESTLE impact and SWOT analyses of the local pharmaceutical market in 2016-2017;</li>
<li>NEW! Distribution of physicians by main specializations and regions of Azerbaijan</li>
<li>Regulatory environment of the pharmaceutical industry of Azerbaijan;</li>
<li>Healthcare system analysis, epidemiology and demographics of Azerbaijan in 2015-2016.</li>
</ol>
<h3 style="text-align: left;">
REASONS TO BUY THE OVERVIEW</h3>
The Overview will upgrade your vision of the Azerbaijani pharmaceutical and healthcare environments by making you possible to:<br />
<ol style="text-align: left;">
<li>Understand the Azerbaijani pharmaceutical market from the helicopter point of view;</li>
<li>Develop the marketing plan for your products in Azerbaijan;</li>
<li>Assess market and revenues opportunities in the Azerbaijani pharmaceutical market;</li>
<li>Elaborate and initiate the market entry process of the pharmaceutical product in Azerbaijan</li>
</ol>
<h3 style="text-align: left;">
AZERBAIJAN ECONOMY SUMMARY</h3>
(Report Excerpts)<br />
<br />
This article is based on the "Azerbaijan Pharmaceutical and Healthcare Industries Overview 2017" report developed by UPharma Consulting and contains short excerpts from this report The full report is available for purchase now.<br />
<br />
<h4 style="text-align: left;">
Azerbaijan in 1990s-2015</h4>
The Republic of Azerbaijan is a country located in the South Caucasus region at the crossroads of Southwest Asia and Southeastern Europe. The country’s GDP amounted US $ 37.9 bn in 2016 (93rd in the world rating).<br />
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Azerbaijan has built an oil-based economy, where the government plays significant role. However, in the early 1990s, the disastrous conditions of the economy were complicated by the war conflict over Nagorno-Karabakh. After a ceasefire in 1994, the President of Azerbaijan Heydar Aliyev signed the “Contract of the Century” with the most significant western oil corporations on joint development of three major oil fields. In the late 1990s the construction of strategically important international pipelines allowed to improve oil exports considerably.<br />
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The “Doing Business-2009” report declared Azerbaijan the most reformist country around the globe. Azerbaijan kept a high position in the next Doing Business reports. Furthermore, in the current economic situation, Standard & Poor’s increased the Azerbaijani rating’s forecast from “stable” to “positive”.... The economy’s high dependence on hydrocarbons output revealed again in 2014 after the fall of the world oil prices.<br />
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In 2015, the government had to devaluate the national currency twice – by 24% in February and by 48% in December. A steep oil price decline in the second half of 2015 led to a deceleration of growth and economic recession. The average monthly salary decreased to USD 296.4 from USD 596.6 in 2014, causing Azerbaijan to lose its status of “middle-income country”. Unemployment is among the critical vulnerabilities of Azerbaijan – about 1.3 mio of employable citizens do not have an official job.<br />
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<h4 style="text-align: left;">
Azerbaijan in 2016</h4>
Throughout 2016, almost all of Azerbaijan’s economic indicators have been on a downward curve. The sustained real growth of the GDP, which started in 2004, shifted to a sharp -3.8% contraction in 2016 with 14.8% inflation on the background. The non-oil industries constructed even more – by 5.3%, declining its share in the economy to 59.6%.<br />
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<h3 style="text-align: left;">
PHARMACEUTICAL MARKET OF AZERBAIJAN</h3>
Pharmaceutical market of Azerbaijan is the biggest one in Transcaucasia (South Caucasus). Before the collapse of the Soviet Union, there were republican wholesale companies, which distributed drugs in Azerbaijan. After the country declared independence, state wholesale companies were privatized.<br />
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Currently, there are 6 major companies, which are main marketers and distributors of pharmaceutical products in Azerbaijan. Wherein, the local production of pharmaceuticals, almost ceased, condemning the country to the big rely on imports.<br />
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The pharmaceutical industry is seen as an essential non-oil sector of the economy. In 2015, the government approved the plan on stimulating the development of the pharmaceutical industry, which envisages the creation of many modern full-cycle manufacturing pants, which meet international GMP standards.<br />
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In 2016, the value of the total pharmaceutical market in Azerbaijan amounted US $ [XXX.x] mio. Economic disturbances affected the market, which decreased by [x.x%] y-o-y and by [x.x%] y-o-y in 2014 and 2015, respectively. In 2016, the currency devaluation led to 28.5% decrease in the market. In the 1HY 2017, the market slumped by [x.x%] PPG vs 1HY 2016 to USD [xxx] mio. In volumes, the market contracted by [x.x%] PPG.<br />
<h3>
<br />PHARMACEUTICAL MARKET FORECAST 2017-2019</h3>
In recent years, foreign companies started considering Azerbaijan not only as a market but also as a prospective place for deployment of production facilities and a hub for accessing the pharmaceutical markets of neighboring republics, including Iran. The government’s favour should promote the development of local pharmaceutical industry in following years. The development of the Pirallahy industrial park is supposed to boost the market, but first new productions are expected to be launched only in 2019.<br />
<br />
Source: <a href="https://www.upharma-c.com/en/news/178-azerbaijan-pharma-and-healthcare-industries-overview-2017/" target="_blank">UPharma Consulting</a></div>
Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comAzerbaijan40.143105 47.57692700000006933.934868 37.249778500000069 46.351341999999995 57.904075500000069tag:blogger.com,1999:blog-5861472110415643495.post-11674312249502902392017-10-19T21:42:00.001+03:002017-10-19T21:44:29.070+03:00Rules for Registration and Expertise of Medicinal Products for Medical Use in EAEU<div dir="ltr" style="text-align: left;" trbidi="on">
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<h2 style="text-align: left;">
1.1 General provisions</h2>
These Rules determine the procedure for registering, confirming registration (re-registration), amending the registration dossier and examining drugs for medical use with the aim of forming a common market for medicines within the Eurasian Economic Union (hereinafter - the Union), as well as the other procedures related to the registration of drugs (hereinafter referred to as procedures related to registration), including:<br />
<div>
<ul style="text-align: left;">
<li>Bringing the registration dossier of a drug registered in the Member States of the Union (hereinafter referred to as the Member States) before the entry into force of the Agreement on Uniform Principles and Regulation for the circulation of medicinal products within the Eurasian Economic Union from December 23, 2014 (hereinafter referred to as the Agreement) until December 31, 2020, in compliance with these rules (hereinafter referred to as bringing to conformity with the requirements of the Union);</li>
<li>Suspension and cancellation of registration of drugs or application limitation of a medicinal product;</li>
<li>Issuance of duplicates of the registration certificate of a drug.</li>
</ul>
</div>
<div>
The requirements of these Rules apply to developers and manufacturers of drugs, holders of drug registration certificates, their proxies, authorized bodies (expert organizations) of Member States in the field of medicinal products circulation.<br />
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Registration in accordance with these Regulations shall be applied to the drugs intended for circulation in the common market of pharmaceutical products within the framework of the Eurasian Economic Union or in the territory of one of the Member States.<br />
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Registration under one trade name of medicines having a different qualitative composition of active substances is prohibited.<br />
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One drug with different trade names may be registered in different Member States in the following cases:</div>
<div>
<ul style="text-align: left;">
<li>Use of the proposed trade name may be contrary to the norms of law and morals or otherwise does not take into account the national cultural and (or) linguistic properties;</li>
<li>intellectual rights to a trade name in the form of a trademark belonging to a person who is different from the person who applied for the registration of the medicinal product (hereinafter referred to as the applicant) or the holder of the registration certificate, and the applicant or holder of the registration certificate cannot provide the relevant license agreement on granting of the right Use of the trademark;</li>
<li>the drug has been registered under different trade names in accordance with the legislation of Member States until December 31, 2020.</li>
</ul>
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Registration of a pharmaceutical product, confirmation of registration (re-registration), an introduction of changes to the registration dossier, as well as procedures related to registration, are carried out by authorized bodies.<br />
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Expert examination of a medicinal product is carried out by an expert organization determined in accordance with the legislation of a Member State.<br />
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Authorized bodies and expert organizations ensure the confidentiality of information contained in the registration dossier of the drug in the process of registration and examination of medicinal products, including information contained in the closed part of the master file for active pharmaceutical substance.<br />
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The applicant, in accordance with the legislation of a Member State, incurs expenses on registration, confirmation of registration (re-registration), changes to the registration dossier and examination of drugs, procedures related to registration, and inspections in order to determine compliance with the requirements of appropriate pharmaceutical practices initiated due to the implementation of these procedures.<br />
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The authorized body (expert organization) of the reference state upon receipt of the application for registration, confirmation of registration (re-registration), modification of the registration dossier and procedures related to drug registration, assigns to it a unique number via the integrated information system of the Union (hereinafter referred to as the integrated system), and informs the applicant.<br />
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The authorized body (expert organization) of the Member State shall provide information related to drug registration, confirmation of registration (re-registration), amendments to the registration dossier, as well as procedures related to registration, authorized bodies (expert organizations) of other Member States, and To the Commission using the integrated system according to the application number in accordance with the formation and maintenance procedure of the Unified Register of Registered Medicines (hereinafter - the Register).<br />
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The authorized body (expert organization) of the reference state shall in no later than 5 working days from the date the applicant submits the registration dossier electronically provide access to the registration dossier information upon the request of the authorized bodies (expert organizations) of the recognition states through the use of the means of the integrated system.<br />
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Based on the results of drug registration, the authorized body of each Member State that registered the medicinal product issues a registration certificate of the pharmaceutical product confirming the fact of its registration.<br />
<br />
A drug registration certificate is issued in accordance with the unified form and rules for filling a medicinal product registration certificate for medical use according to Appendix No. 17 to this Regulation by the authorized body which registered the drug.<br />
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The validity period of the registration certificate for a drug registered for the first time in the referring state is 5 years. At the end of this period, a perpetual registration certificate of the medicinal product is issued, provided that the registration (re-registration) is confirmed.<br />
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In cases specified in Section VII of these Rules, as well as in cases related to the matters of pharmacovigilance, the authorized body may re-issue a registration certificate with a validity period of 5 years following the confirmation of registration (re-registration). The registration certificate of drug registered in accordance with the legislation of the Member States before December 31, 2020 and circulating for 5 years or more on the market of at least 3 member states is issued for an indefinite period in accordance with the procedure for filing it in conformity with the requirements of the Union under section XIII of these Rules.<br />
<h2 style="text-align: left;">
<br />1.2 Definitions</h2>
For the purposes of these Rules, the terms used have the following meanings:<br />
<ul style="text-align: left;">
<li><b>"Holder of the registration certificate"</b> is a legal entity that received the registration certificate for a drug and became responsible for the safety, effectiveness and quality of the medicinal product;</li>
<li><b>"Unified Register of Registered Medicinal Products of the Union"</b> is a common information resource formed within the integrated system and containing information on drugs registered or completed the other procedures related to registration in accordance with these Regulations;</li>
<li><b>"Applicant"</b> is a legal entity competent to submit an application for drug registration, confirmation of registration (re-registration), introduction of changes to the registration dossier of a pharmaceutical products, other procedures related to registration, and responsible for the reliability of information contained in the documents submitted to it and the registration dossier data;</li>
<li><b>"Normative document"</b> is a document that establishes requirements for the quality control of a drug (containing the specification and description of analytical techniques and tests or references to them, as well as the relevant eligibility criteria for these quality indicators, etc.) based on the conducted expertise of a drug; it is approved by the authorized body in case of registration of a drug in the territory of the Union and designed to control the quality of the medicinal product during the post-registration period in the territory of the Union;</li>
<li><b>"General characteristics of the medicinal product"</b> is a document approved by the authorized body of the Member State, in accordance with the acts issued by the bodies of the Union, containing information for the medical workers on safety and effectiveness of the drug;</li>
<li><b>"Representative of the registration certificate holder"</b> is a legal entity registered in accordance with the legislation of a Member State or a separate subdivision of a legal entity located in the territory of a Member State and authorized by the holder of a registration certificate for performance of actions related to the circulation of drugs in the territory of a Member State;</li>
<li><b>"Registration dossier"</b> is a set of documents (including an application), compiled in accordance with these Rules, submitted for conducting procedures related to drug registration or confirmation of registration (re-registration) of the medicinal product;</li>
<li><b>"Registration certificate of a medicinal product"</b> is a document of a unified form issued by an authorized body that confirms registration of a pharmaceutical product and is a permit for its medical use in the territory of a Member State;</li>
<li><b>"Registration number"</b> is the code designation assigned to the drug winning registration in the territory of a Member State;</li>
<li><b>"Registration of a medicinal product"</b> is the procedure aimed at obtaining a permit for medical use of a drug in the territories of one or more Member State carried out in accordance with these Regulations;</li>
<li><b>"Reference state"</b> is a member state that prepares an expert report on evaluation of safety, efficacy and quality of a drug on the basis of drug examination in accordance with these Regulations;</li>
<li><b>"Reference drug"</b> is a drug used as a reference product and is the standard by which the properties of a examined medicinal product are determined (normalized);</li>
<li><b>"Specification"</b> is a list of quality indicators, references to analytical techniques as well as on tests and norms that represent numerical (quantitative) limits, ranges and other criteria for the specified quality indicators;</li>
</ul>
<h2 style="text-align: left;">
<br />1.3 General principles of registration of drugs</h2>
Registration of drugs may be performed at the request of the applicant in succession in the several Member States in accordance with the mutual recognition procedure or simultaneously in the several Member States in accordance with the decentralized registration procedure.<br />
<br />
The procedure for mutual recognition is carried out by:<br />
<ul style="text-align: left;">
<li>A) the reference state in accordance with these Rules with the aim of applying the pharmaceutical product in the market of that state only (national drug registration procedure);</li>
<li>B) in the states of recognition - upon request of the applicant after registration of the drug in the reference state using the procedure of mutual recognition.</li>
</ul>
<br />
The decentralized registration procedure is carried out simultaneously by the several Member States to which an application for drug registration of has been filed, with the choice of the reference state.<br />
<br />
The applicant independently chooses the reference state and, if necessary, the state of recognition when applying for registration of the drug.<br />
<br />
Only one state can act as a reference state.<br />
<br />
The requirements for documents and data of the registration dossier in the format of the general technical document submitted for drug registration have been established by Annexes 1 to 5 to these Regulations.<br />
<br />
Prior to submission of an application for registration of a drug in EAEU, the authorized bodies or expert organizations of the Member States shall have the right, at the request of the applicant, to conduct scientific and pre-registration consultations in accordance with the legislation of the Member States on the issues related to the execution of analytical tests, preclinical and clinical studies (trials), aspects of drug Registration procedures, including the qualification issues, a variation of the application for registration of a drug for the purpose of the volume of documents and registration dossier data, the completeness of the registration dossier, the definition of affiliated persons in the states of recognition, the format for submitting the application and the drug registration dossier, the necessity to provide samples of the drug, reference standards, materials, specific reagents, consumables required for conducting a laboratory quality examination in the expert organization or for its intended purpose, and on the other issues.<br />
<br />
During drug registration procedures, or confirmation of registration (re-registration), or amendments to the registration dossier or procedures related to drug registration, an authorized body or an expert organization of the reference state initiates the inspection for compliance with the relevant good pharmacy practices conducted by the Pharmaceutical inspectorate of this State in case of detection facts that call into question the reliability of the information provided by the applicant in the registration dossier regarding the conducted pre-clinical (non-clinical) studies (trials) of drugs and clinical trials (trials) of drugs or production of the pharmaceutical product, including production of pharmaceutical substances or pharmacovigilance system organization. Such inspections can also be initiated in the cases specified in paragraphs 31, 33, 35, 37,38, 39 of these Rules. Responsibility for the timely initiation of appropriate unscheduled inspections, if necessary, is borne by the authorized body of the reference state.<br />
<br />
The production of drugs must comply with the Rules of Good Manufacturing Practices of the Eurasian Economic Union.<br />
<br />
When applying for drug registration, confirming registration (re-registration), aligning with the requirements of the Union of a medicinal product, the applicant must submit, as a part of the registration dossier, an existing document confirming compliance with the requirements of good manufacturing practices of the Union, the production site (production sites) where the production of the finished dosage form is performed and batch release quality control of the drug claimed for registration, confirmation of registration (re-registration), brought into conformity with the requirements of the Union.<br />
<br />
Until December 31, 2018, with regard to the production site (production sites) of the medicinal product, the applicant, instead of a document confirming compliance with the requirements of good manufacturing practice of the Union, has the right to present a document confirming compliance with the requirements of good manufacturing practices issued by the authorized body of the Member States to the manufacturer of the medicinal product, production site (sites) of a medicinal product that carries out the production of the finished dosage form and release quality control.<br />
<br />
If it is not possible to present the current document confirming the compliance of the production site (production sites) of the drug with the requirements of the Good Manufacturing Practice of the Union, the applicant, when filing an application for registration of a drug before December 31, 2018, or to bring it in conformity with the requirements of the Union, provides the following documents and information instead of this document:<br />
<ul style="text-align: left;">
<li>A) current documents confirming the compliance of the production site (production sites) that produces the finished dosage form and issues quality control of the drug to the requirements of Good Manufacturing Practices issued to the manufacturer of the drug by the competent authority of the country of production of the drug;</li>
<li>B) a copy of the report on the results of the last inspection of the production site (production sites at production stages) conducted by the authorized body of the producing country and/or other authorized bodies during the last 3 years;</li>
<li>C) information on the results of all inspections of this production site (production sites) for compliance with the requirements of good manufacturing practices conducted over the last 3 years;</li>
<li>D) information on complaints regarding the quality of medicinal products produced at the given production site (production sites) over the last 3 years;</li>
<li>E) consent for a pharmaceutical inspection to be conducted in accordance with the requirements of Good Manufacturing Practice of the Union;</li>
<li>F) a copy of the main dossier (site master file) of the production site (production sites).</li>
</ul>
<br />
The reference state, based on the documents submitted by the applicant specified in clause 30 of this Regulation, taking into account the assessment of possible risks, makes a decision on whether to conduct an unscheduled pharmaceutical inspection for compliance with the GMP requirements of the Union for the time of drug registration procedures or to include an inspection of the drug production site (sites) in the plan of inspections in the first 3 years after completion of the registration procedures.<br />
<br />
In case of documentary justification by the authorized body of the reference state, the impossibility of conducting an unscheduled inspection of the production site (production sites) of the drug by the reference state at the time of drug registration procedures, the applicant has the right, upon agreement with the reference state, file an application to one of the Member States for conducting an inspection of this production site (production sites) in compliance with the GMP requirements of the Union.<br />
<br />
In case of a written refusal by the authorized state agencies of recognition in conducting an unscheduled inspection of the production site (production sites) of a drug, the authorized body of the referent state is obliged to organize and conduct an unscheduled inspection within the period of this drug registration procedures.<br />
<br />
The decision on whether to conduct an unscheduled pharmaceutical inspection for compliance with the GMP requirements of the Union is made by the authorized body of the reference state in the process of:<br />
<ul style="text-align: left;">
<li>A) drug registration procedures - for pharmaceutical products produced at the sites where the finished dosage forms are manufactured and the batch release control is performed, and which were not subject to the inspection by the authorized body (organization) of at least one Member State before;</li>
<li>B) the procedures for bringing to conformity with the requirements of the Union - for medicines previously registered in Member States, in case of indication (introduction, modification) of the production site (production sites) previously not inspected by the authorized body (organization) of at least one Member State.</li>
</ul>
<br />
Pre-clinical drug safety studies conducted in non-member states are considered during the expertise of medicinal products provided that these studies are planned, conducted and described in the pre-clinical study report in accordance with the requirements of Good Laboratory Practice equivalent to the requirements of the Union (or not below).<br />
<br />
Clinical studies of medicinal products conducted in non-member states are reviewed during the expertise of medicinal products provided that these trials are planned, conducted and described in the clinical trial report in accordance with the requirements of GCP, equivalent to the requirements of the Union (or at least equal), as well as the principles of the Helsinki Declaration of the World Medical Association "Ethical principles of medical research with human participation as an object of research".<br />
<br />
In the process of drug registration, the reports on previously conducted clinical trials included in Module 5 of its registration dossier are reviewed during the examination in case of one of the following conditions:<br />
<ul style="text-align: left;">
<li>clinical studies shall be conducted in accordance with the legislation of the Member States and in their territory before January 1, 2016 (by the date of the last visit of the last patient (volunteer)) or continued as of January 1, 2016 (with a complete set of patients (volunteers) in the study);</li>
<li>the clinical trials shall be conducted partially or completely in the territories of the countries of the region of the International Conference on Harmonization of Technical Requirements for Registration of Medicinal products for Medical Use (ICH) before January 1, 2016 (on the date of the last visit of the last patient), on the basis of which the medicinal product was registered in the territories of countries of the Region of International Conference on the Harmonization of Technical Requirements for Registration of Medicines for Medical Use (ICH);</li>
<li>clinical studies initiated after January 1, 2016, shall be conducted in accordance with the international treaties and acts constituting the law of the Union, with at least one of the clinical studies conducted in full or in part (with respect to data obtained from the subjects of the study) in the territory of the Union.</li>
</ul>
<br />
The authorized body of the reference state on the basis of the documents and information submitted by the applicant, taking into account the assessment of possible risks, decides whether it is necessary (or not necessary) to conduct an unscheduled inspection of clinical trials of the drug, including bioequivalence studies, within the period of registration of the drug for compliance with the requirements of a GCP of the Union, or on the inclusion of a clinical research inspection in the plan for conducting inspections in the first 3 years after registration of the medicinal product.<br />
<br />
An unscheduled inspection of the pharmacovigilance system of the holder of the registration certificate as a part of the registration procedure for the medicinal product is carried out in cases stipulated by the rules of good pharmacovigilance practice approved by the Commission.<br />
<h3 style="text-align: left;">
</h3>
<h2 style="text-align: left;">
1.4 General principles of expertise of medicinal products</h2>
Examination of drugs is carried out to obtain a scientific assessment of the quality, safety and efficacy of drugs and the risk-benefit ratio, and may include:<br />
<ul style="text-align: left;">
<li>evaluation of documents and information provided by the applicant in the registration dossier of the drug (evaluation of the dossier);</li>
<li>conducting the laboratory tests for compliance with the requirements of the Normative Document and verification of analytical quality control procedures;</li>
<li>preparation of an expert report on evaluation of the medicinal product by the reference state;</li>
<li>assessment of the expert evaluation report by the state of recognition, taking into account the documents and information contained in the registration dossier of the drug.</li>
</ul>
<br />
During development of the pharmaceutical product, execution of pre-clinical (non-clinical) and clinical trials (trials) of the drug, its production, pharmacovigilance and preparation of documents for drug registration procedure, confirmation of registration (re-registration), changes in the registration dossier or other procedures related to registration , Developers, manufacturers and Marketing Authorization Holders and their authorized persons must comply with legislation of Member States, international treaties and acts constituting the right of the Union, as well as to be guided by the best approaches, the implementation of which will ensure the fulfillment of such requirements, and which are set out in decisions and recommendations adopted by the Commission. In case of non-compliance with these recommendations, the applicant must provide a rationale for the admissibility of the chosen approach in terms of ensuring the quality, efficacy and safety of the drug. The presented rationale must be evaluated when examining the medicinal products.<br />
<br />
Examination of the drug is not interrupted for the period of conducting unscheduled pharmaceutical inspections for compliance with the requirements of the Union's proper practices (production, laboratory, clinical, pharmacovigilance), but the final expert evaluation report can be drawn up by the authorized body (expert organization) of the reference state only taking into account the results of unscheduled pharmaceutical inspections (if conducted). These inspections should be carried out within a period not exceeding 180 calendar days from the date of the authorized body's decision to initiate the inspection.<br />
<br />
<br />
<h2 style="text-align: left;">
1.5 The procedure for registration and examination of medicinal products under the procedure of mutual recognition</h2>
<h3 style="text-align: left;">
1.5.1 Registration and examination of medicinal product in the reference state</h3>
The period of drug registration and examination in a reference state shall not exceed 210 calendar days from the date of filing an application for registration of a drug until the day of issuing a registration certificate.<br />
<br />
For the purpose of a drug registration (Marketing Authorization Application), the applicant shall submit the following documents and materials to the authorized body (expert organization) of the reference state:<br />
<ul style="text-align: left;">
<li>Application for registration of a drug in the established form on paper and (or) electronic media in accordance with Appendix no. 2 of these Regulations;</li>
<li>Documents confirming the payment of the fee (toll) for registration and examination of the pharmaceutical product according to the procedure established by the legislation of the reference state;</li>
<li>Drug Registration dossier in accordance with Annexes 1 to 5 to these Regulations on electronic media (in addition module 1 of the registration dossier is submitted on paper (except for the risk management plan, the main dossier (master file) of the production site (production sites) and the master file on pharmacovigilance));</li>
<li>Samples of medicinal products.</li>
</ul>
<br />
In the cases specified in the eighth paragraph of clause 47 of these Regulations, laboratory tests are carried out in the laboratory of quality control of the manufacturer of the medicinal product in the presence of representatives of the expert organization or in the contract laboratory used by the manufacturer in the presence of representatives of the expert organization.<br />
<br />
Examination of a medicinal product in a reference state includes:<br />
<ul style="text-align: left;">
<li>evaluation of completeness and correctness of the documents submitted in the drug registration dossier;</li>
<li>evaluation of documents and information on safety, efficacy and quality of the drug provided by the applicant in the registration dossier;</li>
<li>execution of the laboratory tests for compliance with the requirements of the normative document on quality and reproducibility of the declared quality control procedures carried out in the accredited testing laboratories;</li>
<li>initiation, if necessary, of an unscheduled or planned pharmaceutical inspection in the cases specified in these Regulations;</li>
<li>preparation of an expert report on the evaluation of the drug by the reference state.</li>
</ul>
<br />
The authorized body (expert organization) of the reference state shall, within 14 working days from the date of submission of the application for drug registration, assess the completeness, contents and correctness of registration of the documents submitted in the registration dossier before sending the registration dossier materials for expertise. The applicant is granted 90 calendar days maximum not included in the registration and examination period of the pharmaceutical product, for submission of materials missing in the drug registration dossier, according to the comments of the authorized body (expert organization) of the reference state.<br />
<br />
The authorized body (expert organization) of the reference state rejects the application for drug registration in the event of failure to submit the registration dossier materials on the remarks of the authorized body (expert organization) of the reference state and (or) failure to confirm payment of the fee (fee) for registration and examination of the medicinal product in cases and order Established by the legislation of the reference state.<br />
<br />
The authorized body and (or) the expert organization of the reference state when conducting drug registration and (or) examination of the medicinal product has the right to send a request to the applicant in written and (or) electronic form concerning submission of missing additional information, and request necessary explanations or document clarifications and data presented in the registration dossier.<br />
<br />
The period for submitting a response to the request specified in paragraph 52 of these Rules shall not exceed 90 calendar days from the date of receipt of the request.<br />
<br />
If necessary, the period established in paragraph 53 of these Rules may be extended by the authorized body (expert organization) of the reference state on the basis of the relevant justification of the applicant. The total response time for inquiries should not exceed 180 calendar days.<br />
<br />
The period for documents submission for the applicant upon the request of the authorized body or expert organization during expertise of the drug is not included in the period of examination and registration of the pharmaceutical product.<br />
<br />
If the applicant fails to submit the requested documents and information within the prescribed period, examination and registration of the drug shall be terminated. The authorized body (expert organization) notifies the applicant in writing and (or) by e-mail services within 14 working days from the date of adoption of this decision.<br />
<br />
The interaction of the authorized body (expert organization) with the applicant when sending requests is carried out electronically using an integrated system.<br />
<br />
The expertise of the medicinal product in case of initiating a pharmaceutical inspection for compliance with the proper pharmaceutical practices of the Union shall not be suspended. Wherein preparation of an expert evaluation report is completed by the reference state only after the expert organization of the reference state receives the results of the inspection. An unscheduled pharmaceutical inspection with a report on the completed inspection must be conducted at the time of registration of the medicinal product not exceeding 180 calendar days from the date the decision to conduct the inspection was adopted by the authorized body or an expert organization. The applicant organizes a visit to the production site and / or the research center and / or the inspection of the pharmacovigilance system of the Marketing Authorization holder within 30 calendar days after receiving a request to hold an inspection or offers the dates of visits, but no later than 90 calendar days after receiving the notification that the inspection shall be performed.<br />
<br />
To prepare an expert evaluation report, the expert organization of the reference state prepares the expert reports on the forms in accordance with Appendices no. 6, 7, 8,9, 10, 12 and 22 to these Regulations.<br />
<br />
Based on the results of the expert examination of the drug, the expert organization of the reference state prepares the final expert report on evaluation of the drug submitted for registration, including an assessment of the explanations received from the applicant, documents and information submitted in response to the request of the expert organization or authorized body, in accordance with Appendix no. 16 to these Regulations.<br />
<br />
Expert reports on quality aspects, preclinical, clinical aspects, and final expert evaluation report are compiled in accordance with appendices No. 13, 14, 15 and 23 to this Regulation.<br />
<br />
The expert evaluation report should be updated by the expert organization of the reference state with the appearance of new information that is important for assessing the quality, safety or efficacy of the drug and may affect the benefit-risk ratio of the medicinal product as part of the procedure for amending the registration dossier.<br />
<br />
If, based on the results of the examination of the pharmaceutical product, the authorized body of the reference state takes a positive decision on registration of the drug, the authorized body of the reference state within a period not exceeding 10 working days shall:<br />
issue a drug registration certificate to the applicant in the form in accordance with Appendix No. 17 to these Regulations;<br />
place information about the medicinal product and its active pharmaceutical substances in a single registry with the application of approved summary of product characteristics, instructions for medical use, package mock-ups, the quality standard document, and the final expert evaluation report compiled in accordance with Appendix No. 16 to these Regulations, after confiscation of confidential data and data on experts, the agreed risk management plan for the use of the drug (if necessary) in accordance with the procedure for the formation and maintenance of a unified register.<br />
<br />
The authorized body of the reference state refuses to register the drug based on the results of the examination in the following cases:<br />
<ul style="text-align: left;">
<li>the expected risk-benefit ratio associated with the use of the medicinal product is not favourable;</li>
<li>the effectiveness of the drug is not confirmed by the information provided by the applicant;</li>
<li>the quality of the drug is not confirmed;</li>
<li>the proposed quality control methods and techniques are impracticable;</li>
<li>the applicant provided false information;</li>
<li>according to the results of the appointed inspection during drug registration, its compliance with the relevant pharmaceutical practices of the Union is not confirmed.</li>
</ul>
<br />
In case the authorized body of the reference state adopts a decision to refuse to register a drug, the authorized body (expert organization) of the reference state shall notify the applicant about it in electronic and/or written form within 10 working days from the date of adoption of such decision.<br />
<br />
<h3 style="text-align: left;">
1.5.2 Registration and expertise of a drug under the mutual recognition procedure in the state (states) of recognition</h3>
The applicant, after registration of a drug in the referenced State, may initiate registration in the other Member States selected by the applicant as recognition States by way of a mutual recognition procedure by submitting to the competent authorities of such Member States (expert organization) the following:<br />
<ul style="text-align: left;">
<li>Applications for drug registration under the procedure of mutual recognition on paper and (or) electronic media in accordance with the form provided in Appendix No. 2 to these Regulations;</li>
<li>Documents confirming the payment of the fee (fee) for drug registration and examination of the medicinal product in case and according to the procedure established by the legislation of the state of recognition;</li>
<li>Module 1 of the registration dossier on electronic media.</li>
</ul>
</div>
<div>
<br />
The authorized body (expert organization) of the reference state at the request of the applicant within a period not exceeding 5 working days from the date of receipt of this request shall provide access to the authorized bodies (expert organizations) of the recognition states to the drug registration dossier and the evaluation expert report through an integrated system with the use of additional documents and information submitted by the applicant upon the requests of the authorized body (expert organization) of the reference state.<br />
<br />
The registration of a pharmaceutical product in the state of recognition in the absence of disagreements between the authorized bodies of this member state and the reference state and the availability of an opinion on the possibility of recognizing the expert evaluation report shall be made no later than 90 calendar days after the day of obtaining access to the expert evaluation report.<br />
<br />
Examination of a medicinal preparation under the procedure of mutual recognition in the states of recognition is carried out by:<br />
<ul style="text-align: left;">
<li>reviewing the application, documents and information provided in the registration dossier of a drug;</li>
<li>reviewing the expert evaluation report prepared by the expert organization of the reference state.</li>
</ul>
<br />
The authorized body (expert organization) of the state of recognition within 14 working days from the date of filing the application rejects the application for registration of the drug under the procedure of mutual recognition in case of non-compliance of the application with the requirements of these Rules and (or) failure to confirm payment of the fee (fee) for registration and examination of the medicinal product In the cases and in the manner stipulated by the legislation of the state of recognition.<br />
<br />
When registering a drug under the procedure of mutual recognition, the authorized body (expert organization) of the state of recognition shall, not later than 50 calendar days after obtaining access to the expert evaluation report, forward the request to the authorized body (expert organization) of the reference state in accordance with Appendix No. 18 to these Regulations.<br />
<br />
The applicant sends a response to the request to the authorized body (expert organization) of the state of recognition within a period not exceeding 90 calendar days. The authorized body (expert organization) of the state of recognition shall within 5 working days from the receipt of the applicant's response provide access to the authorized body (expert organization) of the reference state through an integrated system.<br />
<br />
If the applicant fails to provide the documents and information requested by the authorized body (expert organization), the examination and registration of the pharmaceutical product in the given state of recognition is ceased.<br />
<br />
The applicant shall be notified (in electronic form and/or hard copy) of the decision of the authorized body and (or) expert organization within 10 working days from the date of the decision.<br />
<br />
The authorized body (expert organization) of the state of recognition on the basis of the examination of the drug within a period not exceeding 50 calendar days from the date of submission to the state of recognition of the application for drug registration (in the absence of inquiries to the applicant) or within a period not exceeding 20 calendar days from the date of receipt of the applicant's response to a request sent by the authorized body (expert organization) of the state of recognition, using an integrated system, sends a conclusion on recognizing or non-recognizing the expert evaluation report prepared by the reference state to the expert body (expert organization) of the reference state. The authorized body of the reference state brings the obtained conclusion to the attention of the applicant.<br />
<br />
If, based on the results of the examination of the drug, the authorized body of the state of recognition makes a positive decision on registration of the drug, the authorized body of the state of recognition in no later than 10 working days shall do the following:<br />
<ul style="text-align: left;">
<li>issue the registration certificate of the pharmaceutical product to the applicant in accordance with Appendix No. 17 to this Regulation, as well as the guidelines for medical use approved by the summary of product characteristics, the mock-ups of the packages in the national language of the State of Recognition, subject to the relevant requirements in the legislation of the State of Recognition;</li>
<li>coordinate the regulatory document on quality issued by the reference state;</li>
<li>place information about the medicinal product and its active pharmaceutical substances in the unified register with the application of approved summary of product characteristics, guidelines for medical use, package mock-ups, an agreed risk management plan if the medicinal product is used (if necessary) in accordance with the procedure of forming and keeping the unified register.</li>
</ul>
<br />
The registration certificate of the drug is issued by the authorized body of the state of recognition with the validity period of the registration certificate established by the reference state.<br />
<br />
The registration of a drug registered in accordance with these Regulations in the other Member States not listed in the initial application for registration as recognition states, as well as in the states that joined the Union after registration of the pharmaceutical product, is carried out under the mutual recognition procedure based on reviewing the current version of the expert evaluation report prepared by the expert organization of the reference state.<br />
<br />
If the expert evaluation report prepared by the expert organization of the reference state cannot be recognized, the authorized body (expert organization) of the state of recognition shall send the conclusion on impossibility of recognizing this expert report to the authorized body (expert organization) of the reference state, the other states of recognition participating in the drug registration procedure, to the applicant and to the Expert Committee.<br />
<br />
The expert committee shall, within a period not exceeding 60 calendar days from the date of receipt of the conclusion of the authorized body of the state of recognition on the impossibility of recognizing the expert assessment report prepared by the expert organization of the reference state, implement the procedure for considering disagreements in accordance with the procedure established by the Commission.<br />
<br />
The authorized body of the State of Recognition refuses to register the drug if, following the examination of the medicinal product and after conducting the dispute resolution procedure in the Expert Committee, it has been decided that the data presented in the expert evaluation report cannot be recognized as sufficient to confirm the quality and (or) effectiveness, and (or) favorable benefit-risk ratio of the pharmaceutical product.<br />
<br />
In case of disagreement between the authorized bodies regarding the recognition of the expert evaluation report and their revision by the Expert Committee, the authorized body of the recognition state that made a positive decision to recognize the expert evaluation report prepared by the expert organization of the reference state issues a drug registration certificate, the summary of product characteristics, instructions for medical use, package mock-ups and coordinates a risk management plan for the use of the medicinal product (if necessary), Normative Document before the decision of the Expert Committee. At the request of the applicant, the issuance of the drug registration certificate by the authorized body of such state of recognition may be suspended until the disagreements between the authorized bodies of other recognition states and the reference state are eliminated.<br />
<br />
The registration certificate of the drug issued in such cases is valid in the territory of the state of recognition.<br />
<br />
<h2 style="text-align: left;">
1.6 The drug registration process and expertise sequence under the decentralized procedure in the reference state and in the states of recognition</h2>
For the purpose of drug registration according to the decentralized procedure, the applicant shall choose the reference state and the state of recognition.<br />
The duration of the decentralized procedure for drug registration and examination of the medicinal product shall not exceed 210 calendar days from the day of filing of the last of the applications for registration of the medicinal product in the State of recognition until the day the registration certificates of the drugs are issued by the authorized bodies of all Member States participating in the decentralized procedure.<br />
<br />
The drug registration process for a decentralized procedure consists of the following stages, conducted simultaneously:<br />
<ul style="text-align: left;">
<li>registration of a drug in the reference state;</li>
<li>recognition of the expert evaluation report and drug registration in states of recognition.</li>
</ul>
<br />
For the purpose of registration of a medicinal product, the applicant submits the following documents to the authorized body (expert organization) of the reference state:<br />
<ul style="text-align: left;">
<li>An application for registration of a drug in the established form on paper and (or) in the electronic form in accordance with Appendix No. 2 to these Regulations;</li>
<li>Documents confirming the payment of the fee (tax) for drug registration and examination of the medicinal product according to the procedure established by the legislation of the reference state;</li>
<li>Drug registration dossier in accordance with Annexes 1 to 5 to these Regulations on electronic media;</li>
<li>Samples of medicinal products.</li>
</ul>
<br />
Within 14 working days from the date of submission of documents to the authorized body (expert organization) of the reference state, the applicant shall submit to the authorized bodies (expert organizations) of the states of recognition the following documents:<br />
<ul style="text-align: left;">
<li>A statement on paper and (or) in soft copy in the established form in accordance with Appendix No. 2 to these Regulations;</li>
<li>Electronic version of Module 1 of the drug registration dossier;</li>
<li>Documents confirming the payment of the fee (tax) for drug registration and examination according to the procedure established in accordance with the legislation of the state of recognition.</li>
</ul>
<br />
The examination of a drug in a reference state according to the decentralized registration procedure includes:<br />
<ul style="text-align: left;">
<li>evaluation of completeness and correctness of preparation of the submitted documents of the registration dossier of the drug;</li>
<li>evaluation of documents and data submitted by the applicant in the registration dossier of the medicinal product for safety, efficacy and quality;</li>
<li>conduction of the laboratory tests for compliance with the requirements of the normative document on the quality and reproducibility of the declared quality control procedures carried out in the accredited testing laboratories;</li>
<li>initiation, if necessary, of an unscheduled or planned pharmaceutical inspection in the cases specified in these Regulations;</li>
<li>preparation of an expert report on the evaluation of the drug by the reference state.</li>
</ul>
<br />
The expertise of the pharmaceutical product in the states of recognition according to the decentralized drug registration procedure is carried out by consideration of:<br />
<ul style="text-align: left;">
<li>statements, documents and data of the registration dossier of the drug;</li>
<li>an expert evaluation report prepared by the reference state.</li>
</ul>
<br />
The authorized body (expert organization) of the reference state shall, within 14 working days from the date of submission of the application for drug registration, evaluate the completeness and correctness of the submitted documents of the registration dossier of a drug before sending the materials of the registration dossier for expertise. The applicant is granted no more than 90 calendar days not included in the registration and examination period of the drug, for submission of missing materials to the registration dossier to consider the remarks of the authorized body (expert organization) of the reference state.<br />
<br />
The authorized body (expert organization) of the reference state shall, not later than in 14 calendar days from the date of filing the application for registration of the drug in the reference state, after evaluating the completeness of the submitted registration dossier files, submits the registration dossier of the pharmaceutical product to the authorized bodies (expert organizations) according to the procedure of decentralized registration of a drug through an integrated system.<br />
<br />
The authorized body (expert organization) of the reference state rejects the application for drug registration in case the documents and materials of the registration dossier on the remarks of the authorized body (expert organization) of the reference state are not submitted in due time and (or) in case of failure to confirm payment of the fee (tax) for registration and examination of a pharmaceutical product in cases and in the manner established by the legislation of the reference state, and informs the applicant and the authorized bodies (expert organizations) of the states of recognition through the integrated system within a period of not more than 5 working days from the date of the decision.<br />
<br />
The authorized body (expert organization) of the reference state within the period of drug registration and examination of the medicinal product has the right to send the request on submission of the missing additional information, necessary explanations or clarifications concerning the submitted documents and data of the registration dossier to the applicant, in writing and (or) electronically, in accordance with the application No.6,7, 8 attached to these Regulations.<br />
<br />
The authorized body (expert organization) of the reference state shall, within 90 calendar days from the date of commencement of the examination, send to the authorized bodies (expert organizations) of the states of recognition a copy of the reports with the formulation of comments and requests to the applicant in accordance with the Appendices No 6,7, 8 to these Regulations and the preliminary report on evaluation in accordance with the Appendix No. 11 to these Regulations.<br />
<br />
If there are requests sent to the applicant, the authorized body (expert organization) of the state of recognition within 30 calendar days from the date of receipt of the preliminary report on evaluation of the reference state shall send the requests to the authorized body (expert organization) of the reference state, which within 5 working days from the date of receiving the last request from the state of recognition, forms a unified request and sends it to the applicant in accordance with clause 93 of these Regulations.<br />
<br />
The period for submitting a response to the above request by the applicant should not exceed 90 calendar days. Procedures for sending requests and presenting the answers are established by requirements of the legislation of the Member States.<br />
<br />
If necessary, on the basis of the relevant application of the applicant, the response time to the request may be extended by the authorized body of the reference state. The total period for responding to inquiries should not exceed 180 calendar days.<br />
<br />
The examination is resumed after the applicant responds to the inquiries of the authorized body (expert organization) of the reference state.<br />
<br />
If the applicant fails to submit the documents and materials requested by the authorized body (expert organization) in due time, the expertise and registration of the drug shall be terminated. The authorized body (expert organization) notifies the applicant and the authorized bodies (expert organizations) within 14 working days from the date of adoption of such decision in the written and (or) electronic form.<br />
<br />
The expertise of the drug in case of initiating a pharmaceutical inspection for compliance with the proper pharmaceutical practices of the Union shall not be suspended. Upon that the preparation of an expert evaluation report is completed by the reference state only after the expert organization of the reference state receives the results of the inspection. An unscheduled pharmaceutical inspection with a report on the inspection carried out should be conducted within the period of registration of the drug, but not exceeding 180 calendar days from the date the decision on initiating the inspection was made by the authorized body (expert organization).<br />
<br />
The applicant organizes a visit to the production site, the research centre, the pharmacovigilance system of the holder of the registration certificate within 30 calendar days after receiving information on the need for an inspection or specifies a specific visit period, but no more than 90 calendar days after receipt of the information.<br />
<br />
In case of no information from any state of recognition regarding the expertise of the medicinal product (the submission of comments, the results of the examination of the preliminary assessment report), the reference state considers that the state of recognition agrees with the opinion (including comments, if applicable) contained in the preliminary report on evaluation.<br />
<br />
Written consultations between the authorized bodies (expert organizations) of the reference state and the recognition states, if necessary, are carried out electronically using the means of an integrated information system.<br />
<br />
The expert reports on quality aspects, pre-clinical, clinical aspects, final expert evaluation report are compiled in accordance with the instructions given in Annexes 13,14, 15 and 23 to these Regulations. The final expert report on the evaluation of the reference state is drawn up in accordance with the form provided in Appendix No. 16 to these Regulations.<br />
<br />
Within 155 calendar days from the date of submission of the application for drug registration, the authorized body (expert organization) of the reference state shall send the draft of final evaluation report to the recognition state and the applicant in accordance with Appendix No. 16 to these Regulations along with the applicant's responses to the requests, the draft summary of product characteristics, the draft guidelines for instruction for medical use (leaflet), the draft of package mock-ups, the draft of Normative Document, and, if necessary, the draft of risk management plan for the use of the drug. If the expert organization of the reference state prepares a negative draft of the final expert evaluation report and decides not to register a drug in accordance with clause 114 of this Regulation, the examination and registration of the drug shall be terminated. The authorized body (expert organization) notifies the applicant about the decision made within 14 working days from the date of adoption of such decision in the written and (or) electronic form with the above-mentioned final expert evaluation report attached. If the expert organization of the reference state prepares a positive draft of the final expert evaluation report, it is reviewed by the authorized bodies (expert organizations) of the states of recognition.<br />
<br />
In case of no comments were received from the authorized bodies (expert organizations) of the states of recognition or after their withdrawal in accordance with paragraph 106 of these Regulations, the authorized body (expert organization) of the reference state and the recognition states complete the expertise procedure for the pharmaceutical product within 10 working days (175th calendar Day from the date of application for registration).<br />
<br />
If the comments from the competent authorities (expert organizations) of the states were issued regarding the draft of final evaluation report, the draft of summary of the product characteristics, the draft of instruction on medical use, the draft of package mock-up or the draft of Normative Document, the draft of risk management plan for the use of the drug (if necessary), the authorized bodies (expert organizations) of the recognition states, if necessary, carry out consultations with the authorized body (expert organization) of the reference state or recognition states in the electronic form within 10 working days in accordance with the form provided in Appendix 18 to this Regulation (the 165th calendar day from the date of application for registration of the drug).<br />
<br />
In case there are unresolved disputes as a part of mutual consultations, the authorized body (expert organization) of the state of recognition within a period not exceeding 10 working days from the date of receipt of the final expert report on evaluation of the reference state, taking into account the conditions of paragraph 106 of these Rules, using the means of the integrated system, produces the impossibility of recognizing the expert evaluation report prepared by the expert organization of the reference state, with justification of reasons for a negative decision to the authorized body (expert organization) of the reference state and states of recognition, as well as to the Committee of Experts, including issuing such report on paper.<br />
<br />
The expert committee shall conduct a dispute settlement procedure in accordance with the procedure established by the Commission, within a period not exceeding 60 calendar days from the date of conclusion declared by the states that it is not possible to recognize a positive expert evaluation report prepared by an expert organization of the reference state.<br />
<br />
In case the disagreements between the authorized bodies of the referenced State and the States of recognition regarding the recognition of the expert evaluation report are settled, they proceed to completion of drug expertise and issuance of the final documents in accordance with paragraphs 105 and 109 to 113 of these Rules.<br />
<br />
In case the disagreements between the authorized bodies of the referenced State and the States of recognition regarding the recognition of the expert evaluation report are not settled, the authorized bodies of the reference state and the recognition states that have accepted the positive decision to recognize the expert evaluation report shall proceed to completion of expertise and the procedure for issuing the final documents in accordance with paragraphs 105 and 109 - 113 of these Rules. Upon the request of the applicant, the issuance of a registration certificate by the authorized bodies of such Member States may be suspended until the disagreements of the authorized bodies of other recognition and reference States are settled.<br />
<br />
The authorized bodies (expert organizations) of the reference state and states of recognition that have made a positive decision on the expertise results and consider to issue registration of the drug in accordance with paragraphs 105 and 108 of these Rules proceed to the procedure for issuing final documents within a 30-calendar-day period. As well as within the specified period of 10 working days, the applicant is obliged to translate the summary of product characteristics, the draft of instruction for medical use, the mock-ups of the packages into the languages of the Member States, if there is a corresponding requirement in their legislation.<br />
<br />
Within no more than 30 calendar days (the 205th calendar day from the date of submission of the application for drug registration):<br />
<ul style="text-align: left;">
<li>the authorized body of the reference state issues the registration certificate of the drug to the applicant in accordance with Appendix No. 17 to these Regulations, approved by the summary of product characteristics, the medical application guidelines, Normative Document, the package mock-ups, the evaluation expert report (if necessary, the applicant is given the approved summary of product characteristics, the guidelines for medical use and package mock-ups of the medicinal product in the national language of the reference state), and also, if necessary, the agreed risk management plan for the use of the drug;</li>
<li>the authorized bodies of the recognition states issue the registration certificates of the drugs to the applicant in accordance with the form provided in Appendix No. 17 to these Regulations, approved by the summary of product characteristics, the instruction for medical use, package mock-ups of the drug in the official languages of the recognition states (if applicable in the legislation of the Member States), and, if necessary, an agreed risk management plan for the use of the medicinal product.</li>
</ul>
<br />
The authorized bodies of the reference state and the states of recognition publish the information on registration of the drug and the active pharmaceutical substances that are included in its composition into the unified register with the attachment of the approved summary of product characteristics, instructions for medical use, package mock-ups, Normative document, and the final expert evaluation report, compiled in accordance with Appendix No. 16 to these Regulations, after confiscation of confidential data and data on the experts, summary of an agreed risk management plan for the use of the medicinal product (If necessary) in accordance with the procedure for forming and maintaining the unified register.<br />
<br />
The registration certificate of the medicinal product is issued by the authorized body of the state of recognition with the validity period of the drug registration certificate established by the authorized body of the reference state.<br />
<br />
The authorized body of the reference state refuses drug registration under a decentralized procedure in the following cases:<br />
<ul style="text-align: left;">
<li>the ratio of the expected benefit to the possible risks associated with the use of the medicinal product is not favourable;</li>
<li>the effectiveness of the drug is not confirmed by the data provided by the applicant;</li>
<li>the quality of the medicinal product is not confirmed;</li>
<li>the proposed methods and techniques of quality control are impracticable;</li>
<li>the applicant provided false information;</li>
<li>according to the results of the designated inspection, compliance with the relevant pharmaceutical practices of the Union has not been confirmed during the drug registration process.</li>
</ul>
<br />
The authorized body of the state of recognition does not recognize the expert evaluation report prepared by the expert organization of the reference state and thereby denies drug registration under the decentralized procedure if following the results of examination of the registration dossier of the medicinal product and conclusions of the dispute resolution procedure in the Expert Committee, a decision has been taken that the data presented in the expert evaluation report cannot be deemed sufficient to confirm quality, and (or) objectivity, and (or) favorable benefit-risk ratio of the medicinal product.<br />
<br />
<h2 style="text-align: left;">
1.7. Establishment of post-registration measures (registration on terms)</h2>
The authorized body (expert organization) of the reference state with respect to the drug registration process and the procedures related to registration may establish one or more of the following additional requirements:<br />
<ul style="text-align: left;">
<li>Inclusion of certain measures into the risk management system to ensure the safe use of the drug;</li>
<li>Execution of post-registration clinical studies to measure safety of a drug;</li>
<li>Establishment of additional requirements for drug registration and reporting on suspected adverse reactions;</li>
<li>Conducting the post-registration studies of the medicinal product effectiveness, the studies of various aspects of the efficacy of the medicinal product, if necessary, that cannot be investigated before the product is sold;</li>
<li>Other conditions or restrictions for safe and effective use of the medicinal product in accordance with the requirements of the Rules of Good</li>
<li>Pharmacovigilance Practice of the Eurasian Economic Union.</li>
</ul>
<br />
The established conditions and restrictions, as well as the time periods for their implementation, are indicated in the registration certificate, the unified register, as well as in the summary of product characteristics and the instruction for medical use.<br />
<br />
The continuation of presence of the drug in the Union market being the object of the above mentioned procedures, is possible only on the basis of re-assessment of the benefit-risk ratio conducted annually by the authorized body (expert organization) of the reference Member State, with preparation of an expert report on evaluation of the medicinal product. The authorized body of the reference state has the right to cancel the registration certificate of the medicinal product in cases when the holder of the registration certificate does not fulfill the additional requirements established by the authorized body (expert organization) of the reference state with regard to this particular drug when registering it and implementing procedures related to drug registration in accordance with clause 116 of this Regulation, and if the positive decision on the benefit-risk ratio in the process of re-assessment of the benefit-risk ratio conducted annually by the authorized body (expert organization) of the reference state is not confirmed.<br />
<br />
A condition for registration of a drug and confirmation of registration (re-registration) of a medicinal product by an authorized body may be the obligation to be fulfilled by the holder of the registration certificate:<br />
<ul style="text-align: left;">
<li>post-registration safety studies of the medicinal product in case there are risk concerns about this product. In case the risks are related to more than one medicinal product, the authorized bodies of the Member States encourage joint conducting of post-registration safety studies by the holders of the registration certificates of such products,</li>
<li>post-registration studies for efficacy of the product, if the understanding of the disease or the clinical methodology show that previous assessments require a major revision.</li>
</ul>
<br />
The holder of the registration certificate has the right to submit written explanations in response to the introduction of the obligation provided in clause 118 of these Regulations within 90 calendar days from the date of receiving the relevant notification from the authorized body (expert organization) on the introduction of the obligation.<br />
<br />
Based on the written explanations provided by the holder of the drug registration certificate in accordance with clause 118 of these Regulations, the authorized body (expert organization) is required to remove or confirm the obligation to conduct the studies specified in clause118 of these Regulations within 30 calendar days. If the obligation specified in clause118 of these Regulations is confirmed, the conditions for registration of the medicinal product must be changed by including the relevant provisions therein, and the risk management systems should be modified.<br />
<br />
<h2 style="text-align: left;">
1.8. Confirmation of registration (re-registration) of a drug</h2>
The date of the registration confirmation (re-registration) of the medicinal product for all Member States where the medicinal product is registered is determined by the date of registration of the drug in the referenced State under the mutual recognition procedure or decentralized procedure.<br />
<br />
For medicinal products that are not recognized as orphaned in the territory of a Member State in accordance with its legislation, the date of confirmation of registration (re-registration) is determined by the date of registration of a drug in a given Member State under the mutual recognition procedure.<br />
<br />
Confirmation of registration (re-registration) is carried out on the basis of re-assessment of the benefit-risk ratio conducted by the authorized body (expert organization) of the referent Member State, with the preparation of an expert report on the evaluation of the medicinal product.<br />
<br />
The examination of the medicinal product upon confirmation of registration (re-registration) in the states of recognition is carried out by:<br />
<ul style="text-align: left;">
<li>Processing of application, documents and data of the registration dossier;</li>
<li>Processing of the expert evaluation report prepared by the reference state.</li>
</ul>
<br />
During the procedure of confirming the registration (re-registration) of a drug, its circulation on the territory of the Union is allowed.<br />
<br />
The applicant submits applications for confirmation of registration (re-registration) to all Member States where the medicinal product is registered.<br />
<br />
In case the holder of the registration certificate of the medicinal product does not submit an application for confirmation of registration (re-registration) before the expiry of the validity period of the registration certificate, the registration certificate of the medicinal product shall be recognized as invalid.<br />
<br />
The procedure for confirming registration (re-registration) should not exceed 120 calendar days from the date of submission of the application for drug registration confirmation (re-registration).<br />
<br />
The application for registration confirmation (re-registration) of the drug must be submitted not earlier than 210 calendar days before expiry of the validity period of the drug registration certificate in the reference state, but not later than the expiry date of the validity of the registration certificate.<br />
<br />
In order to confirm the registration (re-registration) of the medicinal product, the applicant submits the following documents to the authorized body (expert organization) of the reference state:<br />
<ul style="text-align: left;">
<li>application for confirmation of registration (re-registration) of the drug in an established form on paper and (or) in the electronic form in accordance with Appendix No. 2-1 to these Regulations;</li>
<li>documents confirming the payment of the fee (fee) for confirmation of drug registration (re-registration) and expertise in a case and according to the procedure established in accordance with the laws of the reference state;</li>
<li>modules 1 and 2 of the registration dossier, prepared in accordance with Annexes 1 to 5 to these Regulations, in an electronic media.</li>
</ul>
<br />
The authorized body (expert organization) of the reference state within a period not exceeding 5 working days from the date of submission by the applicant of the documents specified in paragraph 127 of these Rules shall ensure access to the registration dossier of the drug for the authorized bodies (expert organizations) using the integrated system means.<br />
<br />
Within 14 working days maximum from the date of submission of the application for confirmation of drug registration (re-registration) to the referenced State, the applicant shall submit the following documents to the authorized body (expert organization) of each state of recognition:<br />
<ul style="text-align: left;">
<li>an application on paper and (or) electronic media in accordance with Appendix No. 2 to these Regulations;</li>
<li>documents confirming the payment of the fee (toll) for confirmation of drug registration (re-registration) and expertise in the case and procedure established in accordance with the legislation of the states of recognition;</li>
<li>module 1 of the registration dossier, in the electronic form;</li>
<li>in the presence of relevant requirements in the legislation of the Member State, the summary of product characteristics, guidelines for medical use and mock-ups of medicinal product packages in the state language of the state of recognition are also submitted.</li>
</ul>
<br />
The authorized body (expert organization) of the reference state within 14 working days from the date of submission of the application for confirmation of drug registration (re-registration) shall inspect the completeness, contents and correctness of registration of the submitted documents of the registration dossier before sending the materials of the registration dossier for examination.<br />
<br />
The applicant is granted no more than 90 calendar days beyond the time of confirmation of registration (re-registration) and examination of the medicinal product, for submission of missing materials to the registration dossier following the remarks of the authorized body (expert organization) of the reference state.<br />
<br />
The authorized body (expert organization) of the reference state rejects the application for confirmation of registration (re-registration) of the drug in case of failure to submit missing documents to the registration dossier according to previously submitted remarks within the established period and (or) failure to confirm payment of the fee (toll) for confirmation of drug registration (re-registration) and expertise for the medicinal product in cases and according to the procedure established by the legislation of the reference state, as well as due to the violation of the period of submission of the application for confirmation of drug registration (re-registration) specified in paragraph 126 of these Regulations, and notifies the authorized bodies (expert organizations) of the recognition and applicant countries in writing and (or) electronically about it.<br />
<br />
During drug examination conducted by the authorized body (expert organization) of the reference state within 50 calendar days from the date of submission of the application for confirmation of drug registration (re-registration), the preliminary expert report is prepared and sent using the means of the integrated system to the authorized bodies (expert organizations) of the states of recognition according to the form in accordance with Appendix No. 11 to these Regulations.<br />
<br />
In case of disagreement with the conclusions presented in the preliminary expert report on evaluation of the reference state in terms of the benefit-risk ratio of the drug, or if there is a requirement on the part of authorized bodies (expert organizations) of the states of recognition to introduce changes to the summary of product characteristics, instructions for medical use, package mock-ups of a drug or other documents of the registration dossier, the authorized body (expert organization) of the state of recognition no later than in 20 calendar days from the date of sending by the authorized body (expert organization) of the reference state of the preliminary expert evaluation report, sends, via the integrated system, a respective justified request to the authorized body (expert organization) of the reference state.<br />
<br />
In the course of reviewing by states of the recognition of the preliminary expert evaluation report prepared by the expert organization of the reference state, reviewing by the authorized bodies (expert organizations) of the reference state of the requests of the authorized bodies (expert organizations) of states for recognition and reviewing by the authorized bodies (expert organizations) of states of the recognition of the final expert evaluation report prepared by the expert organization of the reference state, the authorized bodies (expert organizations) of the Member States participating in the procedure, using the integrated system means, in accordance with Appendix No. 18 to this Regulation, consider and agree upon the final expert evaluation report prepared by the authorized body (expert organization) of the reference state.<br />
<br />
The authorized body (expert organization) of the reference state during the procedure of confirmation of drug registration (re-registration) and examination of the medicinal product has the right to send the request about submission of the missing additional information, necessary explanations or clarifications concerning the submitted documents and data of the registration dossier to the applicant in writing and (or) electronically. The deadline for submitting a response to the above request by the applicant should not exceed 90 calendar days.<br />
<br />
The time period for submission of documents by the applicant upon the request of the authorized body (expert organization) of the reference state in the process of confirming drug registration (re-registration) and examination of the medicinal product is not included in the time of confirmation of drug registration (re-registration) and examination of the medicinal product.<br />
<br />
The authorized body (expert organization) of the reference state conducts the examination of the applicant's answers, including responses to the requests of authorized bodies (expert organizations) of the states of recognition within a period of no more than 20 calendar days as a part of the expertise of drug.<br />
<br />
If the applicant fails to submit the requested documents and data within the prescribed period, the confirmation of drug registration (registration renewal) and examination of the medicinal product shall be terminated. The authorized body (expert organization) notifies the applicant and the authorized bodies (expert organizations) within 14 working days from the date of making such decision in the written and (or) electronic form.<br />
<br />
According to the results of examination of the drug within a period not exceeding 90 calendar days from the date of submission of the application for confirmation of drug registration (drug registration renewal), the authorized expert body (expert organization) of the reference state shall prepare and approve, in accordance with Appendix No. 16 to these Regulations, the final expert evaluation report, which is sent using the integrated system to the authorized bodies (expert organizations) of all states of recognition involved in the verification procedure of drug registration (drug registration renewal) of the product. The expert evaluation report is drawn up in accordance with Appendices No. 13, 14, 15 and 23 to these Regulations.<br />
<br />
The authorized body (expert organization) of the state of recognition on the basis of the results of examination of the medicinal product within a period not exceeding 20 calendar days from the date of receiving the final expert report on evaluation of the reference state conclusion whether to recognize the expert report on the evaluation of the reference state or not shall be compiled, approved and, using the the integrated system, sent to the authorized body (expert organization) of the reference state in accordance with Appendix no. 18 to this Regulation.<br />
<br />
Proposals of the authorized bodies (expert organizations) of the reference state and states of recognition on changes in the summary of product characteristics, instructions for medical use, drug package mock-ups or other documents of the registration dossier in the event that the applicant agrees with them cannot serve as grounds for refusal to confirm registration (renewal) of the drug.<br />
<br />
If, based on the results of examination of the medicinal product in the reference country, it is established that the benefit-risk ratio is assessed positively and the drug registration dossier, taking into account the changes introduced, meets the requirements:<br />
<ul style="text-align: left;">
<li>the authorized body (expert organization) of the reference state issues a timeless drug registration certificate to the applicant in accordance with the form provided in Appendix No. 17 to these Regulations;</li>
<li>the authorized bodies of the recognition states issue the timeless registration certificates of the drug to the applicant in accordance with Appendix No. 17 to these Regulations, as well as, if necessary, approved by the summary of product characteristics, instructions for medical use, medicinal product package layouts in the national language of the recognition states, within the legislation of these states;</li>
<li>the authorized bodies of the Member States participating in the procedure of confirming drug registration (re-registration) include the necessary information on the drug and its active pharmaceutical substances in a single register, along with a summary of the agreed risk management plan for the use of the drug (if necessary).</li>
</ul>
<br />
If it is impossible to recognize the expert evaluation report prepared by the expert organization of the reference state, the authorized body (expert organization) of the state of recognition shall send, in soft and (or) hard copy, the conclusion on the impossibility of recognizing this expert report with the justification of the decision made by the authorized body (expert organization) of the reference state and state of recognition, participating in the procedure for confirming drug registration (drug registration renewal), as well as to the Expert Committee within the period specified in clause 137 of these Regulations.<br />
<br />
The expert committee shall, within a period not exceeding 60 calendar days from the date of receipt of the opinion of the authorized body of the state of recognition of the impossibility of recognizing the expert report on the assessment of the reference state, implement the procedure for considering disputes in accordance with the procedure established by the Commission.<br />
<br />
The authorized body of the State of Recognition refuses to confirm drug registration (drug registration renewal) if, following the examination of the medicinal product and after the procedure for resolving the disagreements in the Expert Committee, it is established that the expert evaluation report prepared by the expert organization of the reference state cannot be recognized by the authorized body Expert organization of the state of recognition for the reasons specified in<br />
paragraph 146 of these Rules.<br />
<br />
When drug registration (drug registration renewal) is confirmed by the authorized body (expert organization) of the Member State, the fulfillment by the holder of the registration certificate of the conditions related to the registration of the medicinal product set forth in Section VII<br />
of these Regulations is carried out if these obligations were applied to this holder of the registration certificate. When new data on the safety and efficacy of a medicinal product is revealed, the authorized body may introduce changes to the conditions of drug registration and (or) new conditions may be put forward.<br />
<br />
During evaluation of the registration dossier of the drug in the process of confirming drug registration (drug registration renewal) by the authorized bodies (expert organizations) of the Member States, it verifies the fulfillment by the holder of the registration certificate of the obligation to maintain information about the medicinal product in the up-to-date state in the light of current scientific knowledge, taking into account the conclusions of the results assessments and recommendations of the authorized body (expert organization).<br />
<br />
If the authorized body (expert organization) of the reference state identified, at expertise of the medicinal product during confirmation of drug registration (re-registration of the drug), that the obligations specified in clause142 of this Regulation were not fulfilled for objective reasons and changes in the registration dossier of the drug are required, then after the reference state makes a positive conclusion on confirmation of the registration (re-registration) of the medicinal product, the regulatory document (If applicable) should be updated by initiating, by the holder of the registration certificate, the appropriate procedure for introducing changes to the registration dossier within a period not exceeding 180 calendar days from the date the authorized body (expert organization) of the reference state is requested to make changes to the registration dossier of a drug.<br />
<br />
The authorized body (expert organization) of the reference state may allow the introduction of changes to the registration dossier of a medicinal preparation of type I in accordance with Appendix No. 19 to these Regulations upon confirmation of drug registration (re-registration of the medicinal product) in order to avoid additional application for changes to the registration dossier of a drug.<br />
<br />
Based on the pharmacovigilance data, and taking into account the circumstances specified in paragraphs 143 and 144 of these Regulations, upon confirmation of the drug registration (re-registration of a drug) by the authorized body of the reference state, upon the examination of the medicinal product, a decision may be taken to issue a registration certificate with a validity period of 5 years with necessity for subsequent confirmation of drug registration (drug registration renewal) after expiration of the validity period of the drug registration certificate.<br />
<br />
Grounds for refusal to confirm drug registration (drug re-registration) by the authorized body of the reference state and recognition by the authorized state body of the recognition of the expert evaluation report can be the following:<br />
<ul style="text-align: left;">
<li>the preservation of the following serious health risks associated with the use of the medicinal product at the time of confirmation of drug registration (drug registration renewal):</li>
<li>the proven unfavourable benefit-risk ratio or the apparent lack of therapeutic efficacy provided that the conditions for the use of the drug described in the approved summary of product characteristics are met;</li>
<li>the facts established by the pharmacovigilance data indicating an unfavourable benefit-risk ratio (including a significant excess of the reporting frequency of any undesirable reactions in comparison with the data specified in the approved summary of product characteristics);</li>
<li>the discrepancy between the qualitative and quantitative composition of the declared product or repeated quality discrepancy of the drug during its circulation in the market of the Union declared at the time of registration;</li>
<li>inaccurate or outdated data in registration dossier of a drug accompanying the application for confirmation of drug registration (re-registration of a drug);</li>
<li>failure of the holder of the drug registration certificate to comply with the remarks or to respond to questions raised during the examination of the medicinal product within the allotted time;</li>
<li>failure by the holder of the registration certificate to fulfil the obligations under the pharmacovigilance or obligations under the drug registration procedure on the terms.</li>
</ul>
</div>
</div>
Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comEurasia45.4506875 68.83190050000007445.4506875 68.831900500000074 45.4506875 68.831900500000074tag:blogger.com,1999:blog-5861472110415643495.post-87222552452108618302017-10-19T15:49:00.001+03:002017-10-19T15:49:58.274+03:00Ukraine Adopts Crucial Healthcare Reform<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1kX_CWS9cUUKyP4uum-eESnBaSW-3nDvfiDCyJs4DGNyYUaOy968GACG7f5H6IX1zxvD-huyhvJtEtEEWvIDco2djWfMOo_sWXg8WOQbd4Z7vt2E7lu9xoPbVfjq9S1TIZOIcaVKGW2Ew/s1600/Kyiv_Golden+gate.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="596" data-original-width="640" height="596" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1kX_CWS9cUUKyP4uum-eESnBaSW-3nDvfiDCyJs4DGNyYUaOy968GACG7f5H6IX1zxvD-huyhvJtEtEEWvIDco2djWfMOo_sWXg8WOQbd4Z7vt2E7lu9xoPbVfjq9S1TIZOIcaVKGW2Ew/s640/Kyiv_Golden+gate.jpg" width="640" /></a></div>
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Ukraine’s parliament adopted crucial legislation aimed at fixing the country’s ailing healthcare system on Thursday, as opposition groups staged a third day of protests calling for the ruling coalition to speed up political and economic reforms.<div>
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A new healthcare setup based on western models – replacing the remnants of a Soviet system that left Ukraine with one of the highest mortality rates in Europe – was supported by 240 MPs – more than the 226 required for a majority.<div>
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Officials said financing “will follow patients” covered by state medical insurance, who will now choose their primary care doctors. Doctors that service more patients will see a boost in earnings.<div>
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Currently a large share of healthcare funding is inefficiently spent and pocketed by vested interests along layers of bureaucracy, leaving few resources for care and medical professionals’ salaries. Patients are often forced to make illegal cash payments to underpaid doctors.</div>
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“Passage of the reform will be a positive sign that Ukraine is moving in the right direction and making progress towards becoming a European country,” the healthcare ministry said in a statement ahead of the vote.</blockquote>
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The IMF and Ukraine’s western supporters have backed the reform efforts, which have been pushed through despite fierce internal opposition. The successful vote signalled that Ukraine’s pro-western leadership remained capable of pushing forward with reform efforts, despite growing worries about its commitment and stability.</div>
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Concern has mounted that Kiev was failing to keep up with the requirements of a $17.5bn IMF assistance programme that had helped to stabilise the country’s economy after years of conflict with Russian-backed separatists in eastern regions. Earlier this month, lawmakers adopted an overhaul of a dysfunctional pension system, but the IMF has not yet made clear if the legislation was fully compliant with the programme.</div>
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Foot-dragging on other commitments, including further increases on natural gas tariffs and formation of an independent anti-corruption court are among conditions for securing a long-delayed $1.9bn tranche. Formation of the new anti-corruption court is one of three key demands of opposition groups and thousands of protestors that have surrounded the parliament since Tuesday, some camping outside overnight.</div>
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President Petro Poroshenko has pledged to submit legislation on the new court before the end of the year. Ahead of that, lawmakers were hoping to partially defuse the three-day political standoff on Thursday by adopting legislation in a first reading that would strip their immunity from prosecution. Protestors are also seeking reform of the country’s electoral system.<div>
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Source: <a href="https://www.ft.com/content/6358591f-2785-34b7-a1fe-b0d075a014a3?mhq5j=e5" target="_blank">Financial Times</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUkraine48.379433 31.16557990000001237.555531 10.511282900000012 59.203334999999996 51.819876900000011tag:blogger.com,1999:blog-5861472110415643495.post-86929319521547519522017-10-14T23:15:00.001+03:002017-10-14T23:15:46.379+03:00The Lifecycle of a Rare-Disease Cancer Drug<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEga6yYuQjLTdzsc2CooGZ-6dSz-RM_AZsnXiY5LGWV9EeDNcNewn3RaEvdCbcuV6APBtMGilNt5Be8dUEPE1QuOeBlyVOu2vPouypQL7UCx7JvHknUX7WSAK6tsOyZ9BpqkAEDjt80xJZJs/s1600/pretty+image.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="421" data-original-width="720" height="374" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEga6yYuQjLTdzsc2CooGZ-6dSz-RM_AZsnXiY5LGWV9EeDNcNewn3RaEvdCbcuV6APBtMGilNt5Be8dUEPE1QuOeBlyVOu2vPouypQL7UCx7JvHknUX7WSAK6tsOyZ9BpqkAEDjt80xJZJs/s640/pretty+image.jpg" width="640" /></a></div>
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Medicines are increasingly targeted at small patient populations and win orphan drug market protections; a trend labeled the “orphanization” of drugs.</div>
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The pharmaceutical industry says scientific developments have led to more targeted medicines, for example, those that hone in on a genetic mutation. This mutation might apply to several rare cancers, meaning they can test it and license it across several rare diseases, as Novartis did.<br />
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One pharma company’s medicine illustrates how firms can benefit from different layers of market-exclusivity protections.<br />
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Pharmaceutical company Novartis has earned $50.42 billion from its cancer drug Glivec since 2001, using a variety of market-exclusivity protections to shield the medication from the competition.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiz_JPWD8jdJnKlwKQVIvD-qlgMSYZHwoLNZiALrdTqObBcodB2oujH6ePnvIA5axpEIJ3RjmOqt8vUiqAsJQatG2t5dHXVWBmc3D4I7RrnpUSitewsX2Yp1H3jo2g1slefMKXzFktpn6ar/s1600/Glivec-graphic_with-embed.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="972" data-original-width="1600" height="388" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiz_JPWD8jdJnKlwKQVIvD-qlgMSYZHwoLNZiALrdTqObBcodB2oujH6ePnvIA5axpEIJ3RjmOqt8vUiqAsJQatG2t5dHXVWBmc3D4I7RrnpUSitewsX2Yp1H3jo2g1slefMKXzFktpn6ar/s640/Glivec-graphic_with-embed.png" width="640" /></a></div>
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The chart below shows Glivec’s market progression. The drug was licensed for six different rare diseases, earning additional protections in each instance. By later withdrawing these protections, Novartis could also secure additional protections to reap back the lost market exclusivity while the drug was still in development and for testing in children.<br />
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Source: <a href="http://www.politico.eu/interactive/the-lifecycle-of-a-rare-disease-cancer-drug/" target="_blank">Politico</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comSwitzerland46.818188 8.227511999999933346.818188 8.2275119999999333 46.818188 8.2275119999999333tag:blogger.com,1999:blog-5861472110415643495.post-35167623703925699512017-10-09T12:49:00.001+03:002017-10-14T23:35:20.386+03:00Big Pharma Gets Boost as China Speeds Up New Drug Approvals<div dir="ltr" style="text-align: left;" trbidi="on">
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For decades, Chinese patients have struggled to gain access to cutting-edge medicines thanks to bureaucratic delays that have hamstrung drug development. Now a sweeping government overhaul of drug approvals is poised to change that. <br /><br />Beijing on Sunday announced new rules that will speed up approvals of medicines and medical devices, easing bottlenecks in introducing new treatments. The move is also a growth opportunity for international and local drugmakers in the world’s second biggest pharmaceutical market. It also parallels the acceleration of approvals by the U.S. Food and Drug Administration.<br /><br />Under China’s new rules, data from overseas clinical trials can be used for drug registrations in the country. That removes the need for manufacturers to conduct added tests in China after receiving overseas approvals and will likely cut delays in the launch of new drugs by several years.<br /><br />Faster approvals could deliver a revenue boost in coming years to Pfizer Inc., AstraZeneca Plc, GlaxoSmithKline Plc and other multinationals that are expanding there. China spent $116.7 billion on medicine in 2016 and the market is second only to the U.S. in size, according to researcher QuintilesIMS. China is revamping its drug regulatory system as demand for new therapies surges due to an aging population and rising incidence of diseases such as cancer and diabetes.<br /><br /><img height="324" src="https://assets.bwbx.io/images/users/iqjWHBFdfxIU/i4XmZBcTBlEk/v1/800x-1.png" width="640" /><div>
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“For multinational and leading local innovative drugmakers, the anticipated acceleration of approval will improve patients’ access to new medicine and increase revenues for pharmaceutical companies,” said Jialin Zhang, senior health-care analyst at ICBC International Research Ltd.</blockquote>
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Foreign manufacturers control about a quarter of the Chinese pharma market, with the rest held by local players, he estimates.<br /><br />The changes were announced by the State Council, China’s cabinet, just days before a key leadership gathering in Beijing next week. On Oct. 18, delegates will gather for the 19th National Congress of the Communist Party, a twice-in-a-decade shuffling of China’s political decks.<br /><br />Shares of Chinese drugmakers researching new medicines jumped on expectations they will also benefit. Jiangsu Hengrui Medicine Co. advanced 3.4 percent and Shanghai Fosun Pharmaceutical Group Co. rose 2 percent in Shanghai on Monday. The Shanghai Composite Index gained 0.8 percent.<div>
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Promoting Innovation</h3>
Due to insufficient innovation, the pharmaceutical and medical device products marketed in China fall short of international advanced standards, according to the State Council policy statement. The reforms aim to promote restructuring and innovation in order to meet the public’s clinical needs, it said.<br /><br />In the short term, foreign drugmakers might be the prime beneficiaries because they’re already starting to see quicker approvals for their drugs and have deep pipelines of medicines in development, Zhang said. Most local drug companies are still climbing the innovation ladder. That said, Chinese rivals might be bigger beneficiaries over the long-term thanks to expertise in the local market and cheaper costs, he said.<br /><br />For now, most international pharmaceutical companies get only a small fraction of their global sales from China. But they still count on the country to serve as a growth driver given its vast unmet medical needs and a burgeoning middle class that can increasingly afford cutting-edge treatments.<br /><br />Local and multinational drugmakers have for years struggled with delayed approvals in China as a surging number of applications and a relatively small team of government reviewers resulted in a regulatory backlog. The delays in access to life-saving therapies led Chinese patients to buy drugs from grey markets over the Internet or from bootleggers, putting them at risk of receiving counterfeit drugs.<br /><br />Both Pfizer and AstraZeneca said they welcome the new rules.<br /><br /><blockquote class="tr_bq">
“China is a key growth market for AstraZeneca and we are working closely with authorities to ensure our medicines are accessible by the many patients who can benefit from them,” the Cambridge, England-based company said in a statement.</blockquote>
<br />The policies will “pave the way for China’s integration into the system for multiregional clinical trials that supports global drug development,” New York-based Pfizer said in its own statement.<br />Bold Reforms<br /><br />The changes announced Sunday had already been widely telegraphed by the Chinese government, which earlier this year said it was considering overhauling the approval process. The China Food and Drug Administration has been introducing bold reforms in recent years, and the latest policy appears to have received the blessing of top-levels of the central government, said Zhang.<br /><br />More recently, the China FDA has already been working to reduce the backlog. That has already led to speedier approvals for some treatments like AstraZeneca’s lung cancer therapy called Tagrisso, <a href="https://www.bloomberg.com/news/articles/2017-03-28/global-drugmakers-poised-for-windfall-of-new-approvals-in-china">estimated</a> to become a global blockbuster next year.<br /><br />As more innovative drugs make an entrance, foreign manufacturers will still have to manage rising price pressures in China. The government has sought to cut prices to manage costs in its public health insurance system, putting foreign drugmakers through more negotiations with hospitals and local governments and squeezing margins.<br />Patent Protection<br /><br />The reforms announced Sunday include other measures to speed up approvals for clinically needed drugs and equipment, establish a compulsory-licensing system and make it easier for research institutions to conduct clinical trials, according to the document.<br /><br />The government said it will also explore a new system linking drug approvals to patent status. This could potentially delay the introduction of generics when there are legal challenges posed by the patent holder.<br /><br />China’s protection of intellectual properties is still lacking, “and this is also an important reason that restricts the development of our medical innovation industry,” said Wu Zhen, vice minister of China FDA, at a press briefing webcast on Monday.<br /><br />Measures on patents were previously adopted by developed markets such as the U.S., Europe and Japan, and their implementation helped boost both innovative companies and generic drugmakers, Wu said.<br /><br />In the U.S., the FDA is taking advantage of policy groundwork laid in past years to speed drug approvals. Thirty-four new drugs have been approved so far this year -- on pace to nearly double from last year.<div>
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Source: <a href="https://www.bloomberg.com/news/articles/2017-10-09/china-launches-overhaul-of-drug-approval-in-win-for-big-pharma" target="_blank">Bloomberg</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comChina35.86166 104.19539699999996-12.676611999999999 21.578209499999957 84.399932 -173.18741550000004tag:blogger.com,1999:blog-5861472110415643495.post-91917495004841159152017-10-06T22:10:00.000+03:002017-10-09T22:12:11.780+03:00Uzbekistan. The Number of Private Clinics is Expected to Grow<div dir="ltr" style="text-align: left;" trbidi="on">
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State assets of 48 medical facilities are sold at auction in the order of privatization, with the condition of preserving the type of their activities for 10 years. <br /><br />The reason for this decision is the ineffectiveness of their activities. At the same time, it is planned to increase the share of private medical services. <br /><br />In the future, on the basis of privatized facilities, private clinics that provide modern medical services will function. <br /><br />It is important that privatization will take place with the preservation of jobs. <br /><br />In case of equal bids of participants on the terms of bidding, preference in the privatization process is given to the participant-member of the labor collective of the privatized medical institution.<div>
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Source: <a href="http://ut.uz/en/healthcare/the-number-of-private-clinics-will-be-increased-through-privatization-of-state-ones/" target="_blank">UzbekistanToday</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUzbekistan41.377491 64.58526200000005741.377491 64.585262000000057 41.377491 64.585262000000057tag:blogger.com,1999:blog-5861472110415643495.post-11872410484656284502017-10-06T17:53:00.000+03:002017-10-09T01:26:04.227+03:00Pricing of Pharmaceuticals Products in the United Arab Emirates<div dir="ltr" style="text-align: left;" trbidi="on">
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The pricing of pharmaceutical products is a sensitive issue in which governments across the world adopt varying approaches.<br />
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The US, which operates a free-market system in respect of pricing, where the price of pharmaceutical products is determined by the pharmaceutical companies, has come under increased scrutiny, particularly in recent years where the price of pharmaceutical products has risen rapidly. It is a heavily debated topic in the US in respect of which both of the candidates for the upcoming presidential election in the US have raised concerns.<br />
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In the UAE, pharmaceutical pricing legislation is in place and provides fixed margins for the distributors and pharmacies in respect of registered pharmaceutical products sold to consumers.<br />
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In accordance with Article 65 of UAE Federal Law No. 4 of 1983, all pharmaceutical products imported into the UAE, need to be registered with the Ministry of Health. At the time of being registered, a committee at the Ministry of Health will undertake a review of the pharmaceutical product and then determine the “CIF” price for the particular pharmaceutical product. Pursuant to Incoterms, CIF (cost, insurance and freight) generally means all of the costs incurred to get the relevant product from the place of origin to the named port of destination.<br />
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In accordance with Ministerial Resolution (140) of 2013 (the Pricing Resolution), once the CIF price for a pharmaceutical product has been set by the Ministry of Health:<br />
<ol style="text-align: left;">
<li>the agent or distributor of the pharmaceutical products (that supplies such products to private hospitals and pharmacies); and </li>
<li>the pharmacy or private hospitals (that then sell the pharmaceutical products to the end consumer), </li>
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shall each be paid a fixed margin of the CIF price as set out in the table below. The margin changes in accordance with the 3 CIF pricing categories:<br />
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<tbody>
<tr>
<th></th>
<th>CIF Price<br />
(AED 0 – 250)</th>
<th>CIF Price<br />
(AED 0 – 250)</th>
<th>CIF Price<br />
(above, AED, 500)</th>
</tr>
<tr>
<td><div style="text-align: left;">
Distributor / Agent</div>
</td>
<td><div style="text-align: center;">
15%</div>
</td>
<td><div style="text-align: center;">
15%</div>
</td>
<td><div style="text-align: center;">
15%</div>
</td>
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<td><div style="text-align: center;">
Pharmacy / Private Hospital</div>
</td>
<td><div style="text-align: center;">
28%</div>
</td>
<td><div style="text-align: center;">
28%</div>
</td>
<td><div style="text-align: center;">
20%</div>
</td>
</tr>
</tbody></table>
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Accordingly, pursuant to the Pricing Resolution, the price of the pharmaceutical product to the end consumer is the CIF price, plus the agent’s margin, plus the pharmacy’s margin.<br />
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Previous UAE legislation relating to the pricing of pharmaceutical products made a distinction between pharmaceutical products used for chronic diseases and non- chronic diseases, however, the Pricing Resolution removed this distinction and applied a single set of margins as detailed above.<br />
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The Pricing Resolution applies to both prescription pharmaceutical products and pharmaceutical products which are available over the counter. Certain generic products such as paracetamol and aspirin are products that are not covered under the Pricing Resolution.<br />
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The Pricing Resolution applies to the supply of pharmaceutical products to the private sector, including pharmacies and private hospitals. Where drug companies are supplying pharmaceutical products directly to government authorities such as the Dubai Health Authority or to government-owned hospitals or to the Abu Dhabi Health Services Company (SEHA), the pricing of pharmaceutical products is not subject to the Pricing Resolution and the price of pharmaceuticals in this instance is determined as set out in the commercial arrangements entered into between the relevant pharmaceutical company and government body or hospital.<br />
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It should be noted that the increase in the supply of generic pharmaceutical products in the marketplace (as a result of the expiry of patents applying to private label products) and the government’s shift to generic medicines (where possible) is also having an impact on the pricing of pharmaceutical products.<br />
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In 2011, the UAE government issued a circular which prohibited the discounting of pharmaceutical products or the provision of additional/bonus pharmaceutical products, which could also be interpreted to cover sample products. Whilst this is another example of the government attempting to exerting control over the supply and pricing of pharmaceuticals, there are questions whether, in practice, this circular is strictly adhered to or enforced in the marketplace.<br />
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Source: <a href="https://www.clydeco.com/" target="_blank">Clyde & Co LLP</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comtag:blogger.com,1999:blog-5861472110415643495.post-54785841390873086662017-10-06T16:25:00.000+03:002017-10-09T13:26:00.457+03:00Belarus Pharmaceutical & Healthcare Industries Overview 2017 & Forecast to 2017-2019<div dir="ltr" style="text-align: left;" trbidi="on">
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REPORT SUMMARY</h4>
The Overview uncovers economic, pharmaceutical and healthcare insights in a tailored made systematic and business styled manner.<br />
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<table><tbody>
<tr><td><b>Report name:</b></td><td> Pharmaceutical and Healthcare Industries Overview 2017</td></tr>
<tr><td><b>Country:</b></td><td> Belarus</td></tr>
<tr><td><b>Data years:</b></td><td> 2011-1HY 2017</td></tr>
<tr><td><b>Forecast for:</b></td><td> 2017-2019</td></tr>
<tr><td><b>Price:</b></td><td> EUR 500</td></tr>
<tr><td><b>Contents:</b></td><td><span class="label-head"> <a href="https://goo.gl/S2s3jk" rel="tag">Download contents</a></span></td></tr>
<tr><td><b>Options to buy:</b></td><td><span class="label-head"> <a href="https://goo.gl/forms/bcF7MnCMLEZXB5cG2" rel="tag">Request Invoice</a></span><br />
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This report is intended for decision makers, industry professionals, and other stakeholders globally.</div>
<br />
The report covers a 2016 full year data with the forecast of the economics and pharmaceutical market growth to 2017-2019.<br />
<h4 style="text-align: left;">
<br />BELARUS ECONOMICS SUMMARY</h4>
<h4 style="text-align: left;">
2001-2015</h4>
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkLS3dau7-ja-XJuWiLWSMsckhh8Ka0UJ97Wh72vlSnUgef-Jzp9-0ROPWaqr4_U0qAL8L5vfgWLZrufv85oD1h_pIpPtgidw3vmA0qSjBMJ25bMmPRAfII1xRWgQtBOAmdFfQNDXwZwIo/s1600/2017_10_03_Table+1.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" data-original-height="465" data-original-width="434" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkLS3dau7-ja-XJuWiLWSMsckhh8Ka0UJ97Wh72vlSnUgef-Jzp9-0ROPWaqr4_U0qAL8L5vfgWLZrufv85oD1h_pIpPtgidw3vmA0qSjBMJ25bMmPRAfII1xRWgQtBOAmdFfQNDXwZwIo/s320/2017_10_03_Table+1.jpg" width="298" /></a>This article is based on the "Belarus Pharmaceutical and Healthcare Industries Overview 2017" report developed by UPharma Consulting and contains short excerpts from this report The full report is available for purchase now.<br />
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The Republic of Belarus is the 83rd economy in the world by nominal GDP (US $ 45.3 Bn in 2016). With GDP per capita amounting US $ 5,143 (93rd in the world in 2016). Belarus described as authoritarian country, as Alexander Lukashenko rules the state since 1994 and controls main levers of power. After its independence, the country chose a path of “market socialism”, meaning the government was to take control over prices and currency exchange rates.<br />
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Despite a well-developed industrial base inherited from the USSR, Belarus industry and agriculture failed to become competitive. However, in 2000’s due to the burst of oil prices and preferences for oil imports obtained from Russia, Belarus’ GDP was growing 8.3% annually (2001-2008). After 2008 the World economic crisis, Belarus economy started suffering from chronic disturbances followed by inflation increase and budget deficit. In 2011, with the CPI amounted 109%, while the National currency (Belarus Ruble) depreciated from 3,010/US $ at the year beginning to 8,470/US $ at the year-end.<br />
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In 2014, the economy was affected by the economic decline in Russia and fall in the world oil prices. Having, weak diplomatic relations with the US and the EU (sanctions against President Lukashenko and other key figures in the government introduced in 2010 and lifted in 2015), Belarus primarily relies on Russia when demanding external financial aid. In 2014, Belarus received US $ 2 Bn loans from Russia but continued to struggle under the high external debt, trade deficit and ruble devaluation. In 2014, Belarus joined dominated by Russia Eurasian Economic Union (EEU).<br />
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In 2015, after 19 years of active growth, Belarus economy fell by 3.9% y-o-y due to contraction in all the key sectors caused by weak demand on domestic and foreign markets. The year has revealed the country’s high dependence on the economic situation in Russia and a huge need for structural reforms.<br />
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<h4 style="text-align: left;">
2016</h4>
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_x4Ysh6AngESWRJ-nkkyMn6PAeNaX3iHwErfuDSBVw59u-FLimaaGQ4FV7n5QE3UMNkQH0CSyk8jgpKSfJKGjL45_5ZqY2ZfH99xifxFWEdbU5WsOwtnkIhK4476V6apXn-Wh2UMf5Vw2/s1600/2017_10_03_Table+2.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="565" data-original-width="602" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_x4Ysh6AngESWRJ-nkkyMn6PAeNaX3iHwErfuDSBVw59u-FLimaaGQ4FV7n5QE3UMNkQH0CSyk8jgpKSfJKGjL45_5ZqY2ZfH99xifxFWEdbU5WsOwtnkIhK4476V6apXn-Wh2UMf5Vw2/s320/2017_10_03_Table+2.jpg" width="320" /></a>In 2016, domestic demand remained suppressed, and final consumption fell dramatically, while further cuts in directed lending and public capital expenditures continued to dampen gross fixed investments. As the same time, the relations with Moscow started worsening. Russia refused the liberal policy and shifted to a utilitarian calculation of incomes and expenses. After a price gas dispute crude oil supplies from Russia downed by 21%.<br />
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On Jan 2016, the authorities abolished price controls on socially important goods and services and eliminated volume output targets for SOEs. Basic household tariffs for water supply and wastewater treatment were increased by 85%. On Jul 1, 2016, the National Bank of Belarus conducted denomination of the national currency by replacement of old banknotes with the newer ones in the ratio of 1: 10,000. Meanwhile, the World Bank projects Belarus’ GDP to decline by 0.4% in 2017, followed by modest growth of 0.7% in 2018 and 1.2% in 2019.<br />
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<h3 style="text-align: left;">
PHARMACEUTICAL MARKET OF BELARUS</h3>
Despite Ukraine and Russia, Belarus had not inherited important industrial facilities in pharmaceutical sphere after the USSR collapse. At the beginning of the 1990s, the country had few small plants in Minsk and Barysaw. The full version of the report is available for purchase now. Considering social orientation of the Belarus economy, the development the pharmaceutical industry was primarily controlled by the state.<br />
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The local pharmaceutical market has been experiencing harsh reorganisation since 2014-2015 when a severe crisis hit the country on all fronts. The total market value has decreased by almost 20% since then. The government is striving to reallocate the public procurement of pharmaceuticals to locally manufactured products instead of importing them. The total market in 2016 sagged both, in volumes (-2.4%), and in values (-1.4%) in US $ compared with 2015. Reduction n the size of the pharmaceutical market in physical terms has been a trend for the last three years – from 2014 to 2016.<br />
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It is evident that the market demonstrates the same development trend as the whole country’s economy: stagnation, the decline in consumption and lack of visible signs of impetuous recovery. However, we expect the local market to return to insignificant growth in the mid-term (2-3 years perspective) due to overall country’s economic external and internal stabilisation and normalisation of domestic demand.<br />
<br />
Other reports<br />
<ul style="text-align: left;">
<li><a href="https://www.upharma-c.com/en/news/165-ukraine-pharma-healthcare-industries-overview-2016/">Ukraine Pharmaceutical & Healthcare Industries Overview 2016</a></li>
<li><a href="https://www.upharma-c.com/en/news/172-Kazakhstan-pharmaceutical-and-healthcare-report/">Kazakhstan Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Belarus Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Georgia Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Azerbaijan Pharmaceutical & Healthcare Industries Overview 2017</a></li>
</ul>
<br />
Source: <a href="https://www.upharma-c.com/news/175-Belarus-pharmaceutical-and-healthcare-report/" target="_blank">UPharma Consulting</a><br />
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comBelarus53.709807 27.95338900000001648.893959499999994 17.626240500000016 58.5256545 38.280537500000015tag:blogger.com,1999:blog-5861472110415643495.post-91981821581931194612017-10-04T21:51:00.000+03:002017-10-09T21:54:39.862+03:00Uzbekistan's Pharmaceutical Market Gets Rid of Bureaucratic Delays<div dir="ltr" style="text-align: left;" trbidi="on">
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The Republican foreign economic state enterprise "Uzmedexport" signed a memorandum of cooperation with the joint-stock company "Pharmstandard" of the Russian Federation. <br /><br />The purpose of the document is to establish mutually beneficial long-term and confidential cooperation in providing medicines. The term of the memorandum is three years. <br /><br />It should be reminded that from August 1, 2017, import purchases of socially important medicines and medical products by way of exception are carried out by the Republican External Economic State Enterprise "Uzmedexport" without holding tenders on direct contracts at prices approved by the Republican Commission for Control of Provision of Medical Establishments and Population with Medicines and Products of medical purpose.<div>
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<blockquote class="tr_bq">
From August 1, 2017, import purchases of socially important medicines and medical products by way of exception are carried out by the Republican External Economic State Enterprise "Uzmedexport"</blockquote>
<br />The practical value of this measure is that previously imported drugs before entering the territory of our country and pharmacies were subjected to a procedure in several stages. As a result, the necessary drugs because of excessive bureaucracy came for sale late. A measure to buy medicines without tender biddings will solve this problem.<div>
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<div>
Source: <a href="http://ut.uz/en/healthcare/uzbekistan-s-pharmaceutical-market-gets-rid-of-bureaucratic-delays/" target="_blank">UzbekistanToday</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUzbekistan41.377491 64.58526200000005729.199661499999998 43.930965000000057 53.5553205 85.239559000000057tag:blogger.com,1999:blog-5861472110415643495.post-67131126279418645892017-09-26T13:42:00.000+03:002017-10-09T12:50:27.739+03:00Kazakhstan Pharmaceutical & Healthcare Industries Overview 2017 and Forecast for 2017-2019<div dir="ltr" style="text-align: left;" trbidi="on">
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REPORT SUMMARY</h4>
The Overview uncovers economic, pharmaceutical and healthcare insights in a tailored made systematic and business styled manner.<br />
<div>
<br />
<br />
<table><tbody>
<tr><td><b>Report name:</b></td><td>Pharmaceutical and Healthcare Industries Overview 2017</td></tr>
<tr><td><b>Country:</b></td><td>Kazakhstan</td></tr>
<tr><td><b>Data years:</b></td><td>2011-1HY 2017</td></tr>
<tr><td><b>Forecast for:</b></td><td>2017-2019</td></tr>
<tr><td><b>Price:</b></td><td>EUR 500</td></tr>
<tr><td><b>Contents:</b></td><td><span class="label-head"><a href="https://app.box.com/s/oa3negowdftq8pi9eorkes7nan00defg" target="_blank">Download contents</a></span></td></tr>
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This report is intended for decision makers, industry professionals, and other stakeholders globally.</div>
<br />
The report covers a 2016 full year data with the forecast of the economics and pharmaceutical market growth to 2017-2019.<br />
<div style="text-align: left;">
</div>
<h3 style="text-align: left;">
<br />KAZAKH ECONOMY SUMMARY</h3>
This article is based on the Kazakhstan Pharmaceutical and Healthcare Industries Overview 2017 developed by UPharma Consulting. The full report is available for purchase.<br />
<div style="text-align: left;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9gpzFIPekzV8vYD4YhjGdlLoRiTo0OtkmuCgosOdpghjXRPyKXe_f43_x69v_citm6tAaLGcFLYwzz4ZBruDWCfxaLuIefei2TBU4JzjTBIAEsZQR4SPjXKJNmJe3fp2oRZd3NgtmFEVt/s1600/KAZ+tab+1.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" data-original-height="434" data-original-width="453" height="306" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9gpzFIPekzV8vYD4YhjGdlLoRiTo0OtkmuCgosOdpghjXRPyKXe_f43_x69v_citm6tAaLGcFLYwzz4ZBruDWCfxaLuIefei2TBU4JzjTBIAEsZQR4SPjXKJNmJe3fp2oRZd3NgtmFEVt/s320/KAZ+tab+1.jpg" width="320" /></a><br />
The Republic of Kazakhstan is an upper-middle-income country (according to the World Bank’s classification) located predominately in Central Asia. Kazakhstan is the world’s largest landlocked country and the 9th largest country in the world by land area. At the same time, Kazakhstan is the 227th country in the world by population density.</div>
<div style="text-align: left;">
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Kazakhstan’s economy is the largest one in Central Asia while about half of the country’s GDP is contributed by industries based on raw materials. According to British Petroleum's estimates, Kazakhstan possesses 3.2% of the world’s oil reserves and 1.7% of the world’s gas reserves.</div>
<div style="text-align: left;">
After in 2006 the Kazakhstan’s GDP had grown significantly by (10.6%) in a virtue of boost of trade relations with Russia, China, and the CIS countries, in 2008 the economy was affected by the global financial crisis.n 2014, due to the consequences of the Ukrainian crisis and oil prices fall, the GDP growth in Kazakhstan slowed down, while the country’s currency devalued by 19% in February 2014.<br />
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Kazakhstan’s economy continued to suffer from a protracted slowdown in global oil prices and weak domestic demand. Real GDP growth declined from 1.2% in 2015 to an estimated 1% in 2016.<br />
The economic slowdown negatively affected the labour market and affected household income adversely in 2016, with the decline in average real wages (0.9%) and employment (0.5%).<br />
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According to the latest EBRD Transition Report, after struggling with poor growth and social unrest in 2016 due to low commodity prices, the World Bank expects the Kazakh economy to rebound in 2017. Large uncertainties remain around the two parallel reforms.</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrn4JaioQG9afDoDtgLbk7ue26_K5Y0nQFBiPZ7X58U3tn1q4WREqerZG-Df5KiAt0VvKZrPcj7j8-Ip_rC3M8m9eBjhuFt9Sp7aRloKdAio5I-xEfSxt9QwkQCj7Phax5ugcx6XD5_v9s/s1600/KAZ+tab+2.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="445" data-original-width="525" height="271" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjrn4JaioQG9afDoDtgLbk7ue26_K5Y0nQFBiPZ7X58U3tn1q4WREqerZG-Df5KiAt0VvKZrPcj7j8-Ip_rC3M8m9eBjhuFt9Sp7aRloKdAio5I-xEfSxt9QwkQCj7Phax5ugcx6XD5_v9s/s320/KAZ+tab+2.jpg" width="320" /></a><br />
One the one hand, the language of the announcement on political reform was vague and heavily wrapped in rhetoric.<br />
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<h3 style="text-align: left;">
PHARMACEUTICAL MARKET OF KAZAKHSTAN</h3>
Pharmaceutical market of Kazakhstan is the biggest and the most structured one in Central Asia. However, it is weaker compared to the CEE market in terms of business environment and its amount.<br />
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Kazakhstan pharmaceutical market started its formation in the middle 1990s. In 1994, the provision of drugs in the country was carried by the State Joint Stock Holding “Pharmacia” owning 1832 pharmacies. After the demonopolization of the Holding and privatization of its pharmacies, the national drug provision system was destroyed.<br />
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In 1996, transformation processes allowed developing a drugs provision system based on market relationships.</div>
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Currently, the pharmaceutical market of Kazakhstan is among the most developed ones in the CIS region. Consolidation and evolution of vertically integrated companies can be seen in local producers, distributors, and pharmacies together with the improvement of service culture.</div>
<div style="text-align: left;">
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Despite considerable growth dynamics (the market rose 14.3% in 2010-2014), the contribution of the pharmaceutical industry in the country’s GDP remains quite low – 0.2% in values in 2016. The main reason for this is a relatively low base of the local pharmaceutical industry.</div>
<div style="text-align: left;">
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Big expectations are related to the formation of a common market of drugs and medical devices within the EEU. Kazakh producers plan to enhance the export of pharmaceuticals to the EEU states to USD 360 mio per year. The common market foresees harmonization of rules for drugs circulation and registration as well as quality standards for drugs...</div>
<div style="text-align: left;">
<br />
The full version of the report is available for purchase now.</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
Other reports</div>
<ul style="text-align: left;">
<li><a href="https://www.upharma-c.com/en/news/165-ukraine-pharma-healthcare-industries-overview-2016/">Ukraine Pharmaceutical & Healthcare Industries Overview 2016</a></li>
<li><a href="https://www.upharma-c.com/en/news/172-Kazakhstan-pharmaceutical-and-healthcare-report/">Kazakhstan Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Belarus Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Georgia Pharmaceutical & Healthcare Industries Overview 2017</a></li>
<li><a href="https://www.upharma-c.com/en/news/171-cis-pharmaceutical-healthcare-market-overviews-2017">Azerbaijan Pharmaceutical & Healthcare Industries Overview 2017</a></li>
</ul>
<br />
Source: <a href="https://www.upharma-c.com/news/175-Belarus-pharmaceutical-and-healthcare-report/" target="_blank">UPharma Consulting</a><br />
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comKazakhstan48.019573 66.9236839999999826.195413000000002 25.615089999999981 69.843733 108.23227799999998tag:blogger.com,1999:blog-5861472110415643495.post-48495992416949786682017-09-25T17:17:00.000+03:002017-10-14T17:18:31.056+03:00Russia. Analysis of Key Pharmaceutical Market Indicators<div dir="ltr" style="text-align: left;" trbidi="on">
<h2 style="text-align: left;">
Trend</h2>
<br />The year 2016 saw the Russian pharmaceutical market grow by 6.7 percent in ruble terms while decreasing by 3 percent in US dollar terms due to a weaker weighted average ruble exchange rate. In 2016 the market saw a positive growth mainly due to the growth in sales (in ruble terms) in 4Q 2016.<div>
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<br />Market size forecast for 2017 (in ruble terms):</h3>
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<ol style="text-align: left;">
<li>DSM Group: up by 8-9 percent. According to the forecast, the growth will be primarily driven by sales in the commercial segment.</li>
<li>RNC Pharma: up by 10 percent. It is expected that higher consumption, combined with inflation, will be a key driver for growth.</li>
<li>QuintilesIMS: up by 9.2 percent.</li>
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<i>Picture 1. Pharmaceutical Market trends in Russia</i></div>
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Source: Deloitte</div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comRussia61.52401 105.31875600000001-4.7231790000000089 -59.915618999999992 90 -89.446868999999992tag:blogger.com,1999:blog-5861472110415643495.post-21353138073799012032017-09-25T14:20:00.000+03:002017-10-13T14:20:48.648+03:00China Details Major Tasks in Healthcare Reform<div dir="ltr" style="text-align: left;" trbidi="on">
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The central government has detailed major tasks for healthcare reform in 2017 in a circular issued by the State Council on May 5.<br /><br />The document lists 56 tasks focusing on making quality medical care more accessible and setting up diversified medical services.<br /><br />According to the circular, China will expand its tiered medical system and contract-based family doctor services to 85 percent of prefecture-level cities. The contract rate for family doctors among key groups should reach above 60 percent in 2017, covering all impoverished populations, said the circular.<br /><br />Meanwhile, more diversified forms of medical partnership pilot projects should be started nationwide, with top-level public hospitals playing leading roles. Each province should deliver an action plan for carrying out such efforts before the end of June.<br /><br />The government also plans to fully strengthen its ability to serve people with traditional Chinese medicine especially among the grassroots-level hospitals.<br /><br />All public hospitals should carry out comprehensive reforms before the end of September and remove all the medicine markups, the document stated.<br /><br /><div class="separator" style="clear: both; text-align: center;">
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<blockquote class="tr_bq">
The circular also emphasized building modern hospital management systems with efficient coordination, supervision and interaction.</blockquote>
<br />Local governments are required to control annual medical fee increases, with average growth rates kept below 10 percent for all public hospitals, and related indicators should be released to the public periodically.<br /><br /><br /><br />The document stressed the need to finish medical insurance integration among urban and rural residents, forming a unified standard on related items, such as medical benefits and fund management.<br /><br />The government also pledged to roll out an enhanced health information platform across the country which will be better connected with provincial and lower-level platforms, to further meet the growing demand for health and medical services.<br /><br />In addition, eight ministerial departments are expected to introduce 14 related guidelines this year on medical reforms such as promoting medical partnerships, modern hospital management, diversified healthcare services with enhanced social support and a credit system for buying and selling medicine.<div>
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Source: <a href="http://english.gov.cn/policies/latest_releases/2017/05/05/content_281475646380958.htm" target="_blank">The State Council of the People's Republic of China</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comChina35.86166 104.19539699999996-12.676611999999999 21.578209499999957 84.399932 -173.18741550000004tag:blogger.com,1999:blog-5861472110415643495.post-11348903022509204092017-09-22T01:29:00.000+03:002017-10-10T01:30:17.449+03:00Indian Glenmark Charts Out a New Path for Growth<div dir="ltr" style="text-align: left;" trbidi="on">
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Glenmark, one of the top ten Indian drug companies, has unveiled a blueprint for next decade growth with new business strategies and focus areas, considering the pressures and transformation happening in the global generic drug scene.<br />
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The Rs 9,185 crore turnover Glenmark, one of the pioneering Indian drug companies to take up new drug research as a business, is well-positioned to have 30 percent of revenues from specialty and innovative products by 2025, Glen Saldanha, chairman and managing director told its shareholders.<br />
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The company will pursue oncology, dermatology and respiratory as three chosen therapy areas of focus and will straddle the entire value chain of products. The business will revolve around global generic sales, specialty and innovative products, Glen Glen Saldanha said recently at the company's annual general meeting.<br />
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The global drugs industry is going through testing times and in advanced markets, prices are under pressure and channel consolidation, besides high regulatory barriers and government control on drug prices. Indian companies will have to shift their priorities to higher barrier generics as well as diversification into areas like specialty brands to tide over the crisis, Lupin's CEO Vinita Gupta had told Business Today in a recent interview.<br />
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<blockquote class="tr_bq">
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"We are prepared to transition from being a generics-driven company to one that has an optimal mix of generics, specialty and research driven innovative products", said Saldanha.</blockquote>
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Commenting on drug development, he said the company would initiate co-development deals as opposed to the earlier model of selling new drugs under development. The company has about 10 new drugs under development.<br />
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Source: <a href="http://www.businesstoday.in/sectors/pharma/glenmark-charts-out-new-path-for-growth/story/260832.html" target="_blank">Business Today India</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comIndia20.593684 78.962880000000041-8.6044825 37.654286000000042 49.791850499999995 120.27147400000004tag:blogger.com,1999:blog-5861472110415643495.post-35343620506184910752017-09-18T13:54:00.001+03:002017-09-18T13:54:04.549+03:00Chinese Fosun has agreed to acquire 74% of India’s Gland Pharma for $1.1 billion<div dir="ltr" style="text-align: left;" trbidi="on">
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Chinese conglomerate Fosun has agreed to acquire 74% of India’s Gland Pharma for $1.1 billion, sealing a previously unsuccessful deal which was thought to have been blocked by the Indian government.<br /><br />Shanghai Fosun Pharmaceutical Group, the unit of Fosun which will make the acquisition, had previously been aiming to grab 86% of the company for around $1.26 billion with an attempt made in July last year. While the move was given approval from the Competition Commission of India and the Foreign Investment Promotion Board (FIPB), when referred to the Cabinet Committee on Economic Affairs (CCEA), the buyout bid was reportedly blocked. <br /><br />Other explanations have included increased border tensions between India and China as well as concerns over the transfer of technology to Chinese firms.<br /><br />Following this, it was reported that shareholders of Gland Pharma began to consider a new deal, taking advantage of new regulations implemented in 2016 which allows for the foreign direct investment of up to 74% of existing pharmaceutical firms through the automatic approval route.<br /><br />“While an original agreement was entered into over a year ago, a number of approvals already obtained globally are nearing expiration and the parties have agreed to a revised shareholding agreement to complete the deal,” Gland Pharma announced. “The partnership will leverage synergies as foreseen by the management teams of both Gland Pharma and Fosun Pharma. Some of these synergies include the bio-similar programme developed at Fosun being made available for manufacturing by Gland Pharma and introducing them to the Indian market. Furthermore, the partnership will create new channels to sell the products of Gland Pharma in markets where Fosun has an existing presence.”<br /><br />The company announced that its board had approved the new deal while also delaying its closing date to 3 October from 26 September.<div>
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Source: <a href="http://www.pharmafile.com/news/515159/chinas-fosun-group-grabs-74-stake-indias-gland-pharma-11-billion" target="_blank">Pharmalife</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comChina35.86166 104.19539699999996-12.676611999999999 21.578209499999957 84.399932 -173.18741550000004tag:blogger.com,1999:blog-5861472110415643495.post-18904877021038021272017-09-17T12:43:00.001+03:002017-10-09T01:27:53.294+03:00Iran Pharmaceutical Market Opportunities And Market Access <div dir="ltr" style="text-align: left;" trbidi="on">
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Iran has one of the longest histories of medical practice in the world. The ancient Mesopotamians, for example, were carving diagnoses and prescriptions into stone tablets at least 4,100 years ago. Some still survive, as do some of the more rational treatments, such as the use of antiseptic plasters to cover wounds.<br />
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Much later, in around 300 A.D., the university at Gundeshapur became a recognized center for the teaching of evidence-based medicine, and it is thought Persians established the modern hospital system around the same time. The Canon of Medicine, a medical encyclopaedia completed in 1025 by the Persian philosopher Ibn Sina, remained an influential text in European universities until the 1650s.<br />
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In the modern era, however, Iran has fallen off the world‘s medical and pharmaceutical radar. Crippling international sanctions have restricted trade with Iran, severely affecting the pharmaceutical sector and resulting in price controls and a lack of transparency. But since January 2016, most international sanctions have been lifted under the internationally agreed Joint Comprehensive Plan of Action (JCPOA).<br />
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International exporters and investors are free to return, although some sanctions – for example relating to USD-related banking transactions– remain. These are under review, and in the meantime will likely have limited effect on healthcare companies which pay close attention to the remaining compliance requirements.<br />
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The political situation in Iran has also developed further. The reformist government that signed the JCPOA agreement has been working hard to maintain market stability and market openness and is actively seeking foreign investment. Indeed, the level of progress achieved already since lift of sanctions provides sizeable coverage against any deviation in course of policies following changes or transitions in administrations both inside as well as outside of Iran. As a result, early movers have the opportunity of gaining a head start in entering the Iranian market, provided they are aware of the risks and ambiguities and know how to mitigate them.<br />
<h2 style="text-align: left;">
<br />GROWTH OPPORTUNITIES</h2>
Five key factors stand in favour of market entrants seeking growth opportunities in Iran's pharma market:<br />
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<h4 style="text-align: left;">
1. POSITIVE MARKET DYNAMICS</h4>
Iran's economy is in good shape. Its nominal gross domestic product (at market price) is forecast to grow by around 12% annually, reaching a nominal GDP of USD 665 billion in 2020. An Inflation has been halved since 2013 to a 25-year low of around 10%. These and other positive economic indicators explain why Goldman Sachs has identified Iran as having one of the highest growth potentials outside the BRIC nations.<br />
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Graph 1. Development of pharmaceutical sales, GDP, healthcare spending, and population</div>
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<i><span style="font-size: x-small;">(Source: ILIA Corporation, Roland Berger, Roland Berger estimates based on IMF Data and BMI Research)</span></i></div>
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The outlook for healthcare is particularly rosy. Spending is forecasted to grow at a similar rate to GDP, reaching nearly USD 40 billion (6% of overall spending) in 2020, driven by rising Ministry of Health and Medical Education (MOHME) expenditure. Iran's population is also on the up. By 2020 it will have 84.2 million inhabitants – more than Germany.<br />
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Roughly 30% will be aged 19 or under, 60% aged 20 to 59 and 10% aged over 60. This represents a growing customer base for pharmaceutical products, with baby boomers of the 1980s now entering the workforce and fueling out-of-pocket spending.<br />
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In addition, the proportionally high urban population enjoys good access to basic healthcare. In rural areas access is growing due to government reforms, further boosting potential. More than 90% of the population is covered by one of the four government-run health insurers.<br />
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As a result, the Iranian pharmaceuticals market – valued by BMI Research at USD 1.9 billion in 2015 – is predicted to grow at a compound annual growth rate of 6%. By 2025, it will be the fourth largest in the Middle East and North Africa, after Turkey, Egypt and Saudi Arabia.<br />
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<h4 style="text-align: left;">
2. ESTABLISHED PHARMACEUTICAL INFRASTRUCTURE</h4>
Sanctions have forced Iran to build a substantial, largely self-sufficient drug production infrastructure. Some 60 plants produce almost 40 billion drug units each year, meeting 96% of domestic demand. Most do not meet international good manufacturing practice standards, but government initiatives are addressing this.<br />
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Research and development focus mainly on new generic drugs, although investment in novel products is increasing: 12 new treatments for diseases including cancer and diabetes were launched in 2015, for example. Iran’s biotechnology capabilities are also improving.<br />
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The country is queueing among the world's leading nation as for stem-cell research and has a considerable infrastructure of related facilities, e.g. for plasmapheresis (blood plasma treatment). The biggest biopharmaceutical company, CinnaGen, produces Biosimilars of leading immunology and cancer drugs, among others, and invests 20% of revenues in R&D.<br />
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In a nod to the global trend of establishing biotechnology hubs, Iran is also building a government-backed USD 2 billion "Industrial Pharmaceutical City" near Tehran. It will house incubators and startups under the same roof as research labs and biotech producers. Foreign investors will be exempted from taxes and it is hoped the venture will attract international experts.<br />
<h4 style="text-align: left;">
<br />3. SKILLED WORKFORCE</h4>
Some 80% of Iranians receive a secondary education, and the literacy rate is more than 98%, according to the UN. When it comes to science and medicine, its high standards of education appear to be paying off.<br />
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In 2012, the science database Scopus ranked Iran 17th in the world in terms of output of scientific papers, and it was 23rd in terms of highly cited medical articles in 2011. This indicates a significant research base, as evidenced by internationally recognized biomedical centers such as the Pasteur Institute of Iran.<br />
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In 2014, there were 0.93 physicians per 1,000 people according to BMI Research, about 2.5 times less than the US but more than South Africa. However, Iran has suffered from a brain drain in the recent years mainly because of low domestic incomes and market challenges.<br />
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<h4 style="text-align: left;">
4. COMPETITIVE LANDSCAPE</h4>
Iran has a lively pharmaceuticals market. The sector is made up of about 100 companies, with most focused on drug manufacturing. Some also carry out R&D, import non-locally produced drugs or provide distribution, offering ample potential for cooperation.<br />
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The largest producer is Darou Pakhsh Pharmaceutical Manufacturing, which also distributes drugs through its Darou Pakhsh Distribution subsidiary. The company generated revenues of over USD 700 million in 2014 and is listed on the Tehran Stock Exchange.<br />
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The sector is, however, largely consolidated. Most companies are owned by publicly controlled listed investors, such as the Ta'min Pharmaceutical Group (TPICO). Only a few private players, for example, cosmetics company Dr Abidi, exist.<br />
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Graph 2. Competitive landscape of drug manufacturers (selection of largest players)</div>
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<i><span style="font-size: x-small;">(Source: IMI 100, Iranian Stock Exchange, ILIA Corporation, Roland Berger)</span></i></div>
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<h4 style="text-align: left;">
5. A TRADE CROSSROAD</h4>
From the ancient Silk Road to China's new One Belt, One Road project, Iran has always enjoyed a prime position on international trade routes. Its geographic location also makes it an ideal export hub for Central Asia (especially Afghanistan, Russia, Syria, Iraq), a position enhanced by special economic zones and ready access to its 15 neighbours (population: 400 million) through trade agreements.<br />
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Iran's biotech and drug-making expertise have seen it win several large export deals. For example, Afghanistan sources 33% of its pharmaceutical products from Iran, and 11% of all Iran's pharma exports – worth a total of USD 159 million in 2014 – go to Syria under a contract agreement. Germany receives 16%. As Iran ramps up production, its regional trade relationships are likely to grow and help it to expand its export horizons beyond the Middle East.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyFO4hrc8Gv_zdoyl5ZP16ISkjBOgOBFFCp3b7Egtqn-EoPPS2mI-6bT54bDYbbVzxdKqbbibuA-RBWiOc1uhzISl15EaQ-kCnwJjx-eerLqKOS9a9Yj2pWzUWohQQTM8Lle9hcWxkQ8CN/s1600/graph+3.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="805" data-original-width="844" height="610" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyFO4hrc8Gv_zdoyl5ZP16ISkjBOgOBFFCp3b7Egtqn-EoPPS2mI-6bT54bDYbbVzxdKqbbibuA-RBWiOc1uhzISl15EaQ-kCnwJjx-eerLqKOS9a9Yj2pWzUWohQQTM8Lle9hcWxkQ8CN/s640/graph+3.jpg" width="640" /></a></div>
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Graph 3. Iran's Pharmaceutical Trade Relationships</div>
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<i><span style="font-size: x-small;">(Source: ILIA Corporation, Roland Berger, Roland Berger estimates based on IMS data)</span></i></div>
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<br />ENTERING THE MARKET</h2>
Pharmaceutical companies must have a thorough understanding of Iranian market conditions to maximize opportunities and avoid pitfalls.<br />
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1. ENTER – PREPARE WELL</h3>
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<b>A. UNDERSTAND THE MARKET</b><br />
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The Iranian healthcare system exhibits unique features that present both opportunities and hurdles for new entrants. Thorough preparation, including acquiring a deep knowledge of structure, decision makers and key stakeholders, is therefore essential, as is fostering good relationships with market players.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjjWEZ6qh66z0jsu2Vjdl13WwbKI54rLKbCG42rFyrNobccopP6WOb_oT3-RyrqvY1Uuyp15lvAxp20wHRGDtTexyA0HGRsv7I_Zh6WsER9ulz3CPsqTPlItlMIXq8RYMeaIwYC_lDjLBkh/s1600/graph+4.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="472" data-original-width="754" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjjWEZ6qh66z0jsu2Vjdl13WwbKI54rLKbCG42rFyrNobccopP6WOb_oT3-RyrqvY1Uuyp15lvAxp20wHRGDtTexyA0HGRsv7I_Zh6WsER9ulz3CPsqTPlItlMIXq8RYMeaIwYC_lDjLBkh/s640/graph+4.jpg" width="640" /></a></div>
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Graph 4. Regulations and funding bodies in Iran</div>
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<i><span style="font-size: x-small;">(Source: ILIA Corporation, Roland Berger)</span></i></div>
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Regulators and funding bodies: Authorization from two government "gatekeeper" bodies is essential to successful trading in Iran. The first is the Food and Drug Administration of Iran (FDA), an agency that authorizes the import and manufacturing of all drugs, and controls the Iran Drug List (IDL). Only products listed on the IDL can be imported.<br />
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The import of generic drugs listed on the IDL but with a locally produced equivalent is not officially allowed. Exemptions are only rarely granted, for example during a drug shortage. However, physicians are not currently prosecuted for prescribing non-IDL drugs, although this may soon change.<br />
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Currently, 70% of the active pharmaceutical ingredients (APIs) of the world's top-selling drugs are listed on the IDL. But there are notable exceptions, including Insulin lispro (off-patent), used in type-1 diabetes, and Aflibercept (patented), used in the treatment of macular degeneration and metastatic colorectal cancer. The second gatekeeper is the Supreme Council of Health Insurance (SCoHI). It decides which drugs can have their costs reimbursed and at what level.<br />
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The costs of most drugs in Iran are reimbursable, so securing this status ensures a strong competitive advantage. About 400 currently qualify for reimbursement, including some over-the-counter products. Insurers pay either 70% or 90% of costs.<br />
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<b>Providers:</b> Prescribed medicines account for about 90% of the sales value of drugs consumed in Iran. Prescribed medicines account for about 90% of the sales value of drugs consumed in Iran, according to BMI research. This is comparatively high – the proportion in Russia, for example, is 53% – and means the prescribing physician is usually the key decision maker in the buying process. Most physicians split their time between public and private practice.<br />
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Public healthcare facilities include more than 17,000 health houses – the first point of contact for patients – and 6,000 hospitals. The four health insurers own or contract these services, covering the full cost of treatment for their members. There are around 25,000 private general practices and 150 hospitals, which can usually only be accessed by those with private insurances.<br />
<b><br /></b> <b>Pharmacies:</b> There are around 8,500 pharmacies in Iran according to various articles published in the Iranian Journal of Pharmaceutical Research. About 55% are linked to public institutions, enjoying a large market share due to their near-monopoly position in the provision of scarce and expensive drugs. The rest are privately owned. Online pharmacies are yet to have an impact, selling only around 1% of drugs.<br />
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The influence of pharmacists on the buying decision is limited to 85% of patients present them with a predetermined prescription, limiting pharmacists to the role of operator. But in the case of OTC drugs, which make up about 15% of total sales, pharmacists can advise patients on their buying decision. This market is likely to expand in the future as growing numbers of OTC drugs lose their reimbursement status due to cost-cutting and become less attractive to prescribe, increasing the influence of pharmacists in the buying process.<br />
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<b>Patients:</b> As in most drug markets, patients are consumers of prescription medicines rather than selectors of them. This is particularly true in Iran, with its high proportion of prescription drug sales. But, as with pharmacists, they have a growing decision-making power in the OTC market due to the fall in medicines with reimbursable status.<br />
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<b>Existing market players:</b> About 100 domestic pharma companies are active in Iran and can serve as accelerators for multinationals entering the market. Most are affiliated with government-backed investment companies, ensuring ready access to crucial public stakeholders such as the FDA.<br />
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<b>B. CONSIDER THE REGULATORY FRAMEWORK</b><br />
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<b>Approval process:</b> FDA authorization is a prerequisite for the sale of drugs in Iran, whether the product is imported or produced locally. The application process to introduce new drugs is not dissimilar to those in developed markets, but may be less transparent and more time-consuming.<br />
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The first step involves registering the product by submitting drug data, import-export and authorization documents. Once certified by an Iranian consulate, these documents are passed to legal commissions for consideration. If successful, the drug is added to the IDL. The process usually takes about a year. If approval is being sought for a drug already listed on the IDL, the imported version need only be approved by an FDA-accredited laboratory.<br />
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<b>IP rights:</b> There is little patent protection for drugs in Iran. Under current legislation, pharmaceutical formulae and compounds are not patentable, leading t an extensive unauthorized production of generic medicines. However, with Iran currently seeking World Trade Organization membership, this is likely to change as the country will have to adopt the WTO's patent protection terms.<br />
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<b>Pricing:</b> Drug prices are determined by the FDA's Pricing Commission. It decides on the expenses incurred by producers and importers for each drug, and then fixes a price under the top-mark system, taking into account the upper range of cost.<br />
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<b>Reimbursement:</b> Health insurers pay 70% (outpatient dispensed) or 90% (inpatient dispensed) of the cost of drugs with reimbursement status. The remaining amount is paid by users. Most drugs, for example, cancer medicines, have this status, but numerous drugs commonly used in the West do not, including pantoprazole, a treatment for excess stomach acid.<br />
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2. LAND – START SMART</h3>
<b><br /></b> <b>A. DECIDE FOR LOCAL PRODUCTION OR EXPORT</b><br />
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New multinational entrants will first want to decide whether to make their product in Iran or export it to the country. There are benefits and costs to both. In the case of generic drugs already manufactured in Iran, local production has advantages because of the ban on, or heavy taxing of, imported equivalents. But both options are viable for new drugs or non-IDL listed generics.<br />
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Imports of these face only the general 5% customs tariff, and in selected cases, this is even subsidized. Local production may also be cost efficient, either at owned facilities or via cooperation with in-country partners. It also affords rudimentary IP protection.<br />
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<b>B. ESTABLISH BACK-END PROCESSES AND ROUTE TO MARKET</b><br />
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The setting up of backend functions, such as sourcing and manufacturing, will vary depending on the choice of local production or import. But in both cases the route to market is identical. Sourcing: Half of the raw material used in drug manufacturing in Iran is imported. But local sourcing is on the rise, and a number of base materials required to make rare medicines have reportedly been produced since 2013.<br />
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<b>Manufacturing:</b> The government is planning to expand Iran's already considerable drug-making capacity. It wants to build on its mostly generics-producing base by branching out into the manufacture of patented medicines as part of its post-sanctions strategy.<br />
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But whether carried out at self-owned facilities or those of partners, manufacturing in Iran must abide by certain cultural rules. Selected medicines and dosage advice must be halal compliant, for example, and patient information must be provided in English and Farsi.<br />
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<b>Imports:</b> Finished pharmaceutical products are shipped in by importing companies, which are often subsidiaries of large local pharma groups. These offer significant opportunities to tap into local expertise. Import taxes and custom tariffs range between 0 and 65% depending on whether the product has a locally produced equivalent.<br />
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<b>Distribution:</b> Drugs are primarily distributed by six government-owned companies. But smaller private operators are increasingly entering the market, with about 20 currently active. The state-backed Darou Pakhsh Distribution, which deals in both local and imported products, is the market leader with a 25% share.<br />
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Overall, the 10 largest distributors have a 75% market share. This level of consolidation makes the leveraging of existing local networks an attractive option. European operators, for example, Dutch ingredients group Barentz, are already entering into such agreements.<br />
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<b>Exports:</b> Iran's government is keen to promote the export of medicines to help chip away at its negative trade balance. By 2025 it hopes to have balanced exports and imports of medicines; as such, drug export income is tax exempt, and initiatives are underway to improve manufacturing practices. Export licenses must be signed off by MOHME's Food and Medicine Deputy.<br />
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3. SUCCEED – WIN FAST</h3>
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<b>A. ADDRESS PROMISING MARKET SEGMENTS</b><br />
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Several areas of unmet or growing demand exist in the Iranian pharma market. For example, although some 85% of all medicines consumed in Iran are prescribed by a physician, increasingly blurred lines between OTC and prescription drugs mean that a significant number of prescription medicines can be bought directly by users.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqlE7mxaew-yt49JvDfhUuXWBR3Di9ZeBVfz3BfUCUb1OLCAMrnyTLq-cYiXJpkEzyeaCQZjPJIuH6NV52CuYIwaoTXkd7w70UagZDH4UiMqHIw98rxarrUSUB0Kqrv3AzlvDad-Ca7f7X/s1600/graph+5.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="511" data-original-width="671" height="486" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqlE7mxaew-yt49JvDfhUuXWBR3Di9ZeBVfz3BfUCUb1OLCAMrnyTLq-cYiXJpkEzyeaCQZjPJIuH6NV52CuYIwaoTXkd7w70UagZDH4UiMqHIw98rxarrUSUB0Kqrv3AzlvDad-Ca7f7X/s640/graph+5.jpg" width="640" /></a></div>
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Graph 5. Iranian pharmaceutical market split according to value.</div>
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<i><span style="font-size: x-small;">(Source: BMI Research, Science direct, ILIA Corporation, Roland Berger)</span></i></div>
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Analgesics account for most OTC purchases, due to high demand and their reimbursement status. As health awareness rises in the country, the market for vitamin and dietary supplements is expected to become another important area according to Euromonitor. In the prescription sector, there are several supply gaps owing to the fact that many prescribed drugs cannot be produced locally.<br />
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The largest are for oncology, multiple sclerosis and insulin drugs. An expected epidemiological shift towards chronic diseases is likely to crank up this demand further. Large pharma companies are already moving to fill these shortfalls. For example, in 2015 Novo Nordisk announced it was building a USD 70 million insulin-manufacturing plant to exploit the fact that 65-70% of Iranian insulin is imported.<br />
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This move took advantage of the Iranian government's efforts to attract companies that can satisfy domestic demand by producing locally. Generic drug makers can also benefit from Iran's long tradition of favouring generic prescription medicines to keep down costs. Demand for low-cost generics in rural areas is particularly high, presenting opportunities for companies with scale advantages.<br />
<b><br /></b> <b>B. APPLY A SUCCESSFUL MARKETING MIX</b><br />
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Detailing visits by sales representatives are the primary marketing tool used by Iranian pharma companies, not least because they offer the best way to engage with providers, the key decision makers. Visits are usually undertaken once every two to five weeks, depending on the provider's prescription volume and their local population density.<br />
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Pharmacists, due to their lower prescription influence, receive much less attention. But this may change as more OTC products become available and their role in drug selection becomes more influential. Other forms of drug marketing in Iran are little developed. While the Iranian Medical Council allows advertisements aimed at health care professionals, any direct-to-consumer marketing in public media is limited. The use of alternative marketing techniques, such as sampling and promotional mailing, is rare.<br />
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4. LEVERAGE – BENEFIT FROM PARTNERS AND COMPETITORS</h3>
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<b>A. ESTABLISH DOMESTIC PARTNERSHIPS</b><br />
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Collaboration with local players is the dominant strategy employed by international companies wanting to establish a foothold and grow in the Iranian pharma market. As mentioned, such partnerships offer new entrants access to infrastructure, distribution networks and key stakeholders.<br />
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Large Western pharma companies such as Pfizer, Merck, Novartis, Roche, Boehringer Ingelheim and Sanofi have all already employed this tactic. Several multinationals, for example, have partnered with Tehran-based Modava Pharmaceutical Company to facilitate distribution through its affiliate Shafayab Distribution.<br />
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Novartis also sources secondary packaging from Modava and is instituting API production, too. Tie-ups with domestic companies have proven particularly beneficial for companies wishing to establish import-export businesses, as local expertise can be tapped to help manage regulatory compliance.<br />
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<b>B. LEARN FROM OTHERS</b><br />
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Foreign investment in the Iranian pharmaceuticals market is picking up a pace and becoming increasingly ambitious. In addition to the partnership strategies being employed by the multinationals, most of which focus on distribution, other companies are establishing a bricks-and-mortar presence.<br />
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For example, the Indian generics manufacturer Cipla is planning a new production plant in Iran to take advantage of the growth in the generics sector, and Novo Nordisk's insulin-production facility is designed to exploit the growing demand for biologicals and biotechnology expertise. Additionally, Italian construction company Pesina Costruzioni is cooperating with MOHME to build five new hospitals in Iran as part of the government's strategy to upgrade its health infrastructure.<br />
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While foreign investment is on the up, history has shown that international companies must do their homework before entering the Iranian market. Several failed because they underestimated the local competition, offering products that were expensive compared to local drugs. Others were tripped up by regulations or the now lifted sanctions.<br />
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Companies that have sought partnerships have fared best, with those prepared to go the extra mile and support local research doing best of all. Sanofi, for example, signed a Memorandum of Cooperation on research, helping it to secure government goodwill.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1rvs5pR0vB-QmVlvHc4QdPTR_y_9gboGUJy07E3d1_MoODAVYeA_cSs802fXdujAq8lTWTTZijN21mSBQ9I8KenW2W-XAL8YlUEuO6OLL5jKCrtFX6bK_NF5zYKuqFuIDYMMT7XdcnPaP/s1600/graph+6.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="663" data-original-width="753" height="562" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1rvs5pR0vB-QmVlvHc4QdPTR_y_9gboGUJy07E3d1_MoODAVYeA_cSs802fXdujAq8lTWTTZijN21mSBQ9I8KenW2W-XAL8YlUEuO6OLL5jKCrtFX6bK_NF5zYKuqFuIDYMMT7XdcnPaP/s640/graph+6.jpg" width="640" /></a></div>
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Graph 6. Case studies on market entries by pharma players</div>
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<i><span style="font-size: x-small;">(Source: Reuters, Press Research, Roland Berger)</span></i></div>
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<b>CONCLUSION</b><br />
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There is little doubt that Iran offers multinational pharmaceutical companies clear growth opportunities. But it is not a straightforward operating environment and its unique character presents risks rarely found in most developed or developing markets. In order to mitigate these and prepare foundations for success, it is recommended that new players comprehensively investigate local market mechanics, the regulatory framework, business culture and domestic competition before entering.<br />
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New entrants may also wish to consider partnering with local partners to smoothen their landing and enhance growth once operational. They should also closely study the actions of competitors. Prevention, after all, is better than cure.<br />
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<iframe allowfullscreen="" frameborder="0" height="714" marginheight="0" marginwidth="0" scrolling="no" src="//www.slideshare.net/slideshow/embed_code/key/miXhctBeNwWU8D" style="border-width: 1px; border: 1px solid #ccc; margin-bottom: 5px; max-width: 100%;" width="668"> </iframe> <br />
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<strong> <a href="https://www.slideshare.net/avigraf/pharmaceutical-market-in-iran-opportunities-and-market-access" target="_blank" title="Pharmaceutical Market in Iran - Opportunities and Market Access">Pharmaceutical Market in Iran - Opportunities and Market Access</a> </strong> from <strong><a href="https://www.slideshare.net/avigraf" target="_blank">UPharma Consulting</a></strong> </div>
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Source: Roland Berger Think Act</div>
Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comIran32.427908 53.68804599999998632.427908 53.688045999999986 32.427908 53.688045999999986tag:blogger.com,1999:blog-5861472110415643495.post-1740163455951401062017-09-15T22:15:00.000+03:002017-09-16T22:24:17.967+03:00Hikma Pharmaceuticals To Establish A Factory In Kazakhstan<div dir="ltr" style="text-align: left;" trbidi="on">
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Kazakh officials agreed to the establishment of a factory for Hikma Pharmaceuticals in the central Asian country with a starting capital of $150 million, Deputy Prime Minister for Economic Affairs and Minister of Industry, Trade and Supply Jawad Anani said on Saturday.<br />
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In a statement following the Jordanian-Kazakh Joint Committee’s fourth meeting that concluded in Astana on Thursday, Anani said this is an important step for Jordanian pharmaceuticals to penetrate the Kazakh market and other neighbouring markets, the Jordan News Agency, Petra, reported.<br />
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Both sides also agreed to examine the possibility of establishing an air shipping company to increase the commercial exchange volume, and the possibility to export to nearby markets.<br />
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At the meetings, Anani said Jordan attaches great importance to economic and trade cooperation with Kazakhstan and he urged the private sector in Amman and Astana to benefit from the “distinguished bilateral ties” between them. <br />
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Source: <a href="http://www.jordantimes.com/news/business/hikma-pharmaceuticals-establish-factory-kazakhstan" target="_blank">The Jordan Times</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comKazakhstan48.019573 66.9236839999999826.195413000000002 25.615089999999981 69.843733 108.23227799999998tag:blogger.com,1999:blog-5861472110415643495.post-67525818274892053352017-09-13T16:13:00.000+03:002017-10-08T16:14:36.486+03:00Legal Protection of Selection Inventions in Russia<div dir="ltr" style="text-align: left;" trbidi="on">
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Last year the discussion on patenting of inventions in the pharmaceutical field unexpectedly was given a new start. The Federal Anti- Monopoly Service (FAS) poured oil on the fire of this debate, according to which the Russian PTO improperly allows granting patents for such “minor,” from the point of view of FAS, improvements like the use of known pharmaceutical compositions for new purposes, new methods of treating diseases with the known pharmaceutical compositions and new methods of preparation of the known substances. According to FAS the issuance of these patents is abuse of intellectual property rights and reveals drawbacks in the procedure for granting patents.</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwep5VFtDcX0X-jsbl5Mmss0ybpLbHntFlvZrvjSEI2I2uYy8O2N9if_1qkS0RXCCFnsGaEY1mpzQye9RbNIm47p1jhig6nYR3v5O-xdAEh3TyO6tPd9ZIKTufJKbYHD7jATdX7x53a3tt/s1600/best-of-russia.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="503" data-original-width="894" height="360" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwep5VFtDcX0X-jsbl5Mmss0ybpLbHntFlvZrvjSEI2I2uYy8O2N9if_1qkS0RXCCFnsGaEY1mpzQye9RbNIm47p1jhig6nYR3v5O-xdAEh3TyO6tPd9ZIKTufJKbYHD7jATdX7x53a3tt/s640/best-of-russia.jpg" width="640" /></a></div>
<br />In this connection, FAS proposed to exclude the possibility of patenting known substances, methods of treatment and methods of using the pharmaceutical compositions for a new purpose, which do not have any features of the invention, since the existence of such possibility leads, according to FAS, to multiple patenting of the same invention and the unreasonable extension the term of protection of intellectual property rights (FAS, following some patent agents, calls this technique the maintenance of an “evergreen patent”).<br /><br />Of course, the Russian PTO did not agree with this assessment of FAS of the situation in the field of patent protection of pharmaceutical inventions. The position of the Russian PTO is, that regardless of what a claimed invention represents (including the use for a new purpose, a new method of treatment with the known means, etc.), the base to provide legal protection is conformance to the requisites of patentability “novelty,” “inventive step,” and “industrial applicability.” The Russian PTO noted that legal protection of inventions in the form of the use of a known substance for a new purpose and the method of treatment using a known substance, contrary to FAS, does not extend legal protection of the existing active ingredient. For example, the current legislation allows obtain a patent for the use of the active substance for a new purpose. Furthermore, the validity of such a patent in no way shall be related to the life of the patent for the active ingredient. The issuance of such patents is the usual practice adopted in most developed countries, relying, inter alia, on international agreements.<br /><br />The case in point went through all the judicial instances and the judgment of the Commercial Court of Moscow was upheld<br /><br />It is generally acceptable throughout the world the issuance of patents for so-called “selection inventions,” which, according to the opponents of such patents, also relate to “evergreen” patents. A selection invention is an invention related to a chemical compound falling within the general structural formula of the group of known compounds (the Markush formula), but not described as specifically obtained and investigated, and at the same time characterized by new properties unknown for this group in qualitative or quantitative terms. The selection inventions relate to chemical compounds, and the examination of applications is carried out in exactly the same way as the examination of patent applications for inventions relating to chemical compounds.<br /><br />Assessment of the novelty of the claimed chemical compound is carried out according to the entire combination of its characterizing features (structure, presence of specific substituents in certain positions and mutual alignment of the groups and atoms within the molecule). With regard to the selection inventions, this assessment shall also be carried out without fail, and it precedes the analysis and accounting of the new property of the claimed chemical compound (novel in relation to the properties of the well-known group of chemical compounds described by the Markush formula). The record of this novel property, belonging to the technical result, is only one of the associated requisites for recognition of the patentability of a chemical compound itself, but it is not the unique and self-sustainable.<br /><br />In Russia the problem in question is regulated by patent rules according to which: “a chemical compound falling within the general structural formula of a group of known compounds or a composition based on it are recognized as complying with novelty criteria if the chemical compound as such is not known from the prior art and there is no information regarding the basic substance, the process for its preparation and its properties, which became publicly available before the priority of the invention” (Para. 70 of the Rules for inventions of the Russian PTO).<br /><br />Similarly, the procedure for checking compliance with the inventive level criteria of selection inventions is generally the same the procedure for checking the inventive level of other chemical compounds with the defined structure, i.e. account is taken of the difference in the properties of the claimed and disclosed compounds unified by a known formula of a common structure and the extent of this difference is taken into account (it is not considered being sufficient proof of an inventive level the difference between quantitative indicators within the margin of error) (paragraph 9.1.12. of the Examination Guidelines of Applications for Inventions).<div>
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Accordingly, paragraph 78 of the Rules for inventions provides that a selection invention, i.e. a chemical mixture falling under the general structural formula of the group of known compounds, but not specifically described as specially obtained and studied, and at the same time showing new unknown properties in this group in qualitative or quantitative terms (selection invention), is recognized being non-obvious to a person skilled in the art and involves an inventive step requisite. Thus the patentability of inventions, called selection inventions, is based, like any other inventions, upon their statutory criteria. No case has come to our notice, in which the Russian PTO or the court would recognize the invention being patentable only because they qualified it as a “selection invention” without evaluating all of the criteria of patentability (novelty, inventive level and industrial applicability).<br /><br />A spectacular example of a selection invention is the invention according to the Russian patent No.2114838 for a group of inventions “Triazole Derivatives, Pharmaceutical Compositions and Intermediates” issued in the name of Pfizer Inc. (US). The said patent, in particular, protects also the exclusive rights to the active substance having the international non-proprietary name (INN) of VORICONAZOLE. The invention characterized in independent claim 1 according to Russian patent No.2114838 relates to triazole derivatives of general formula I.<br /><br />The compounds which are characterized by structural formula I in the independent claim 1 of the Russian patent No.2114838 are covered by the general structural form of a group of compounds known from the Russian patent No.2095358 (independent claim 1 and dependent claims 2, 3) as well as compounds which methods of preparation are known from the SU patent No.1836366 issued in the name of Pfizer Inc. (US). However, the compounds characterized by structural formula I under the Russian patent No.2114838 are not disclosed in the patent documents RF No. 2095358 and SU No.1836366, as specially obtained and studied. Thereby, in the specification of the invention under the Russian patent No.2114838 there are indicated the methods of preparing the compounds characterized in independent claim 1 and dependent claims 2-10. Furthermore, the specification contains experimental data evidencing that the compounds substituted by halogen in a certain position (substitute Y in the structural formula of independent claim 1), possess a surprisingly high level of antifungal activity (against species Aspergillus spp fungi) in comparison with the compounds disclosed under the Russian patent No.2095358 but which do not have the above- mentioned substitute. Thus, the triazole derivatives of the general formula I according to independent claim 1 under the Russian patent No.2114838 exhibits quantitatively new properties comparing with the compounds described in patent documents RF No.2095358 and SU No.1836366 as specially obtained and studied. It is conducting special research and discovery of new properties that allowed Pfizer Inc. (US) obtain the said patent for the selection invention.<br /><br />Meanwhile, other pharmaceutical market players - producers of generics are not comfortable with such approach. They believe that patents for selection inventions should not be issued because they artificially extend the term of validity of the earlier patent for a group of compounds covered by the general structural formula of the group of compounds contained in the original patent with an earlier priority date. In particular, this became one of the key issues in case No.A40-30012/2015, which was considered by the Moscow Commercial Court.<br /><br />In the case in question Pfizer Inc., (US) filed a lawsuit against the CJSC Canonfarma Production and its distributors for protection of the exclusive rights for the invention under the patent No.2114838 which protects the active ingredient INN VORICONAZOLE. The respondent for its part argued that since the active ingredient VORICONAZOLE is covered by the general structural formula of the patent No.2095358 which term of validity has expired, hence marketing of the pharmaceutical composition with the active ingredient INN VORICONAZOLE does not violate the patent No.2114838 since the invention passed into the public domain in accordance with Art. 1364 of the Civil Code of the Russian Federation. In order to verify the parties’ submissions the court ordered an expert report. In their report the experts confirmed that the controversial pharmaceutical composition both the invention under the patent No.2114838 and the invention under the patent No.2095358 are used. Having analyzed the expert opinion the court stated that the conclusion of experts on the use of the invention under the Russian patent No.2095358 does not repeal and in no way affects the conclusions of the experts on the use of the invention under the Russian patent No.2114838. Without regard to the number of patents used in the pharmaceutical composition the conclusion on the use of the particular patent remains unchanged.<br /><br />The simultaneous use in the pharmaceutical composition both of the patent which has passed into the public domain, and the patent being in force, is not a ground for discharging of responsibility for infringement of the exclusive rights to the patent being in force.<br /><br /><blockquote class="tr_bq" style="text-align: left;">
The current legislation allows obtain a patent for the use of the active substance for a new purpose</blockquote>
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The law contains no ban on the use in the pharmaceutical composition of more than one patent; however, the law bans the use in the pharmaceutical composition of a patent without the consent of the patent owner (Articles 1229, 1358 of the Civil Code of the Russian Federation). That is why the use in the pharmaceutical composition “Voriconazole Canon” according to the Russian patent No.2095358 (passed into the public domain due to expiration of the period of validity) does not make lawful the use in the same pharmaceutical composition according to Russian patent No.2114838 being in force. A different interpretation would purport the open-ended opportunity to avoid liability for violation of intellectual property rights through the simultaneous use of both the invention passed into the public domain and the invention under the patent being in force. Neither Article 1229 of the Russian Civil Code, nor Articles 1358 or 1359 of the Civil Code contain such an exception / ground for exemption from liability for infringement of the exclusive rights in the invention. The conclusion about the use of the invention under the Russian patent No.2095358 which passed into the public domain in accordance with Article 1358 of the Russian Civil Code does not negate the inference about the use of the valid Russian patent No.2114838, for infringement of the exclusive right to which the liability is incurred in accordance with Article 1252 of the Civil Code.<br /><br />The Russian patents Nos.2095358 and 2114838 protect different technical solutions, “otherwise these patents could not have been issued.” Aside from the above arguments the respondent argued that the company Pfizer Inc. abused its right by extending the life of the patents of the Russian Federation Nos.2114838 and 2095358, since by its actions the company tried to limit competition and occupy a dominant position on the market of pharmaceuticals.<br /><br />Meanwhile the Court for intellectual property rights noted in its decision that according to the tenor of paragraphs 1 and 2 of Article 10 of the Civil Code for recognition of actions of a person as the abuse of the right the court should establish that the malice of such a person was directed to a willful unfair use of the rights; that his or her only goal was causing harm to another person (the absence of other bona fide purposes). This abuse of right must have sufficiently clear character and the conclusion to that effect should not be the result of speculation. However Canonfarma Production did not provide relevant evidence in the case file. At the same time, on their own right, the actions of Pfizer Inc. to extend the period of validity of the aforementioned patents did not contradict current legislation.<br /><br />As a result of consideration of this dispute the court found the patent for the selective invention being infringed. Thereby, in fact, the Court confirmed that the patent for the selection invention is subject to protection regardless of the term of validity of the original patent having the general structural formula of a group of compounds which the selection invention falls under. Furthermore, the court confirmed the right of the patent owner to renew both patents (the original patent and the patent for the selection invention) on the basis of the same marketing authorization according to the provisions of paragraph 2 of Article 1363 of the Russian Civil Code.<br /><br />The case in point went through all the judicial instances and the judgment of the Commercial Court of Moscow was upheld.<br /><br />As it was mentioned in this article, the issue of the long-term validity of patents for pharmaceutical compositions including patents for selection inventions, worries both the manufacturers of generics and the FAS. The Federal Anti-Monopoly Service expresses extreme concern over a possible monopoly on the invention in such a vital area as pharmaceuticals and believes that the law favors artificial extension of validity of a patent in the pharmaceutical field.<br /><br />FAS has drafted several versions of changes in the Civil Code of the Russian Federation aimed at allowing the use of patented inventions without the consent from the patent owner (through a compulsory licensing mechanism or issuing a use permit by the Government).<br /><br />In one of the legislative drafts in particular, it seeks to complement Article 1350 of the Civil Code with a provision regarding the right of the government to allow the use of an invention, utility model or industrial design without the consent of the patent holder in order to protect the life and health of the people. Now the law allows the government to do so in the best interests of defense and security. In any case, both the current legislation and the legislative draft provide that the right holder shall immediately be notified of such a government decision and it should be paid commensurate compensation.<br /><br />Until now, all FAS initiatives to amend the legislation in this regard have been rejected by the government, and all the patents issued within the framework of existing legislation continue to have effect and are subject to protection by the state. As the heads of the Russian PTO correctly pointed out at the roundtable discussion organized by the Office in February 2016 any decisions related to the change in the pharmaceutical patenting practice should be well balanced and coordinated with all interested parties.</div>
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Source: Gorodissky & Partners</div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comMoscow, Russia55.755826 37.61729990000003555.1838695 36.326406400000032 56.3277825 38.908193400000037tag:blogger.com,1999:blog-5861472110415643495.post-13496775806345122242017-09-01T13:48:00.000+03:002017-10-09T15:24:22.287+03:00Ukraine Launches Procurement of Medicines/Medical Devices Reform<div dir="ltr" style="text-align: left;" trbidi="on">
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The Cabinet of Ministers approved the reform’s Concept on August 23, 2017.<br />
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The reform shall be implemented by 2019 to bring transparency, efficiency, best international practices and fair competition into the procurements system. The Concept introduces a new approach to public procurement of medicines and medical devices through the independent centralized procurement organization, coordinated through MoH.</div>
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The organization shall take over the public procurement functions from MoH, regional governments and public healthcare institutions. The Concept defines two main stages of the reform implementation:</div>
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<li>Setting up of the organization, creating a regulatory framework and internal policies/procedures, selection and training of the core team; conducting pilot procurement projects (2nd half of 2017);</li>
<li>Further development and capacity building of the organization in the areas of e-infrastructure (using a specialized electronic procurement platform), analytics, international cooperation; conducting selected regional procurement projects (2018).</li>
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When fully implemented, the centralized procurement organization will procure medicines and medical devices at the national (replacing the current temporary system of procurement through international organizations), as well as local level.</div>
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MoH is now developing a detailed implementation step plan, to be approved further by the Cabinet. The need for the reform is caused by ineffective and non-transparent centralized procurement system of MoH, as well as a decentralized system on the regional level, used in the recent decades.</div>
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Source: <a href="http://www.marchenkodanevych.com/node/219" target="_blank">MarchenkoDanevych</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUkraine48.379433 31.16557990000001237.555531 10.511282900000012 59.203334999999996 51.819876900000011tag:blogger.com,1999:blog-5861472110415643495.post-43300447062231848022017-08-23T14:20:00.000+03:002017-09-11T14:21:19.815+03:00Ukraine. The List of Rare Diseases Has Been Supplemented<div dir="ltr" style="text-align: left;" trbidi="on">
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The Ministry of Health has approved changes to the List of Rare (Orphan) Diseases which Shorten Life of Patients or Lead to Disability and for Which There Are Recognized Methods of Treatment (hereinafter - the List). The corresponding Order of the Ministry of Health of Ukraine No. 731 as of June 29, 2017, has been registered with the Ministry of Justice.<br /><br />Rare endocrine diseases, digestive disorders and metabolic disorders, as defined in Section I, have been supplemented with following 7 new positions: impaired ornithine metabolism, argininemia, ornithine carbamoyltransferase deficiency; impaired glycine metabolism; other disorders of lipid accumulation, Wolman's disease; hereditary erythropoietic porphyria; late cutaneous porphyria; other porphyrias; lipomatosis which was not classified elsewhere.<br /><br />Section IV list “Rare Diseases of the Nervous System” has been supplemented with 10 positions, which include the following:<br /><ul style="text-align: left;">
<li>encephalitis, myelitis and encephalomyelitis; encephalitis, myelitis and encephalomyelitis together with diseases classified in other sections; progressive encephalomyelitis with rigidity and myoclonus;</li>
<li>secondary parkinsonism caused by other external factors;</li>
<li>other forms of secondary parkinsonism;</li>
<li>dystonia;</li>
<li>craniocervical dystonia spreading to the larynx and upper limbs;</li>
<li>blepharospasm;</li>
<li>other dystonia;</li>
<li>unspecified dystonia;</li>
<li>specific epileptic syndromes;</li>
<li>hereditary motor and sensory neuropathy.</li>
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Also, the List has been amended with Section XI “Rare Diseases of Sclera, Cornea, Iris and Ciliary Body”, containing 2 points: interstitial (stromal) and deep keratitis (Kogan syndrome), and iridocyclitis.<div>
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Source: <a href="https://www.legalalliance.com.ua/eng/news/the-list-of-rare-diseases-has-been-supplemented/" target="_blank">Legal Alliance Company</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUkraine48.379433 31.16557990000001237.555531 10.511282900000012 59.203334999999996 51.819876900000011tag:blogger.com,1999:blog-5861472110415643495.post-58587276344237680722017-08-05T14:57:00.000+03:002017-09-11T14:58:25.459+03:00Uzbekistan. Pharmaceutical And Healthcare Regulatory Updates<div dir="ltr" style="text-align: left;" trbidi="on">
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This legal alert highlights the most important recent legal developments that affect the Uzbek pharmaceutical industry as a whole and activities of foreign pharmaceutical producers and their representative offices in Uzbekistan in particular.<div>
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UzMedEksport as an Exclusive Importer of pharm Products:</h3>
Starting from August 1, 2017, import of socially important pharmaceutical products shall be done exclusively by the State Enterprise “UzMedEksport” without conducting tender bids. The import shall be done by the conclusion of direct contracts with the suppliers at the prices set by the Republican Commission for Control over Supply of the Population with Pharmaceutical Products (the “Commission”).</div>
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The Decree instructs the Commission to develop a new mechanism for setting wholesale and retail prices for socially important pharmaceutical products, where the fluctuation of foreign currency exchange shall have minimal effect.<br /><br />Presidential Decree No. ПП-3137 dated 17.07.2017</div>
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Retail Trade in Pharmaceuticals:</h3>
The Ministry of Health shall establish its own chain of pharmacies with the aim of increasing availability of socially important pharmaceutical products.<br />Certification of medical products can now be done only by the state certification bodies accredited by “Uzstandard”.</div>
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<br />All pharmacies shall have their licenses re-issued by the Council of Ministers of the Republic of Karakalpakistan and local municipalities (khokimyats) until January 1, 2018.<br />The Ministry of Health shall develop and maintain a publically open registry of pharmacies, whose licenses were revoked due to the violation of license requirements, including price formation, as well as employees of such pharmacies, who were directly art and part in such violations.<br /><br />Presidential Decree No. ПП-3137 dated 17.07.2017</div>
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<br />Free Economic Zones for Pharmaceutical Activities:</h3>
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These free zones specialize in the cultivation of medical plants in newly established plantations within free economic zones and production of local pharmaceutical products from pharmaceutical substances and medical plants materials grown in those plantations. The free economic zones are established for 30 years with possible further extension of the term.Seven free economic zones have been established specializing in the production of pharmaceutics.</div>
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These are:</div>
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<li>(i) ‘Nukus-pharm’ in the Republic of Karakalpakstan,</li>
<li>(ii) ‘Zomin-pharm’ in Jizzakh region,</li>
<li>(iii) ‘Kosonsoy-pharm’ in Namangan region,</li>
<li>(iv) ‘Sirdaryo-pharm’ in Sirdarya region,</li>
<li>(v) ‘Boysun-pharm’ in Surkhandarya region,</li>
<li>(vi) ‘Bustonlik-pharm’ and</li>
<li>(vii) ‘Parkent-pharm’ in Tashkent region.</li>
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<br />The free economic zones are subject to certain tax, customs and forex incentives. Particularly, legal entities registered in these economic zones are exempted from land tax, corporate profit tax, property tax, infrastructure development tax, unified tax payment, mandatory deductions to the State Road Fund and the off-budget School Fund as well as customs payment for the equipment, spare parts and raw materials used for production needs.<br /><br />Presidential Decree No. УП-5032 dated 03.05.2017<br /><br /> <h3 style="text-align: left;">
<br />Market Foreign Currency Rate for Commercial Banks:</h3>
Amendments were introduced to the Regulations on OTC Forex Market No. 294 of July 10, 2001. Particularly, the requirement that Uzbek banks in their dealings with customers must refer to the average price of foreign currency determined during interbank trade sessions was abolished. It is now a ‘market rate’ that is to be used in banking operations, however, the Decree fails to provide the definition of the ‘market rate’.<br /><br />As it may be seen, interbank trade sessions, which were used as an instrument for controlling forex rates, are now supposed to be not a decisive indicator in forex dealings between banks and customers. With that, however, no clue is given what the “market rate” represents and indirect influence of the Central Bank may be used in order to fix such a rate.<br /><br />Decree of the Cabinet of Ministers No. 449 dated 30.06.2017</div>
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<br />Abolishment of Mandatory Sale of Export Proceeds:</h3>
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Starting from August 1, 2017, exporters of goods, works and services are not required to sell 25% of their export proceeds to their servicing bank at the official foreign currency exchange rate.<br /><br />Presidential Decree No. ПП-3157 dated 28.07.2017<br /></div>
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Import VAT: Exemption for Pharmaceutical Raw Materials:</h3>
<br />Amendments were introduced to the List of Raw Materials Used for Production of Pharmaceutical Products. 89 items were amended and 924 new items were added.</div>
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Source: <a href="https://kostalegal.com/category/legal-alerts/srt/legal-dev-affecting-t-phar-ind" target="_blank">Kosta Legal</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUzbekistan41.377491 64.58526200000005741.377491 64.585262000000057 41.377491 64.585262000000057tag:blogger.com,1999:blog-5861472110415643495.post-79516753357119892212017-08-02T11:19:00.000+03:002017-09-17T11:24:26.833+03:00Belarus Plans To Apply For The Membership In PIC/S<div dir="ltr" style="text-align: left;" trbidi="on">
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In the late 2018 – early 2019, Belarus plans to submit its application for the membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This was announced by Elena Alexandrova, the Deputy Head of Pharmaceutical Inspection and Drug Provision Organization Division – Head of Pharmaceutical Inspection Department of the Ministry of Health.<br /><br />Joining this authoritative international organization will confirm that the competency and knowledge of national inspectors are at the world-class level and, accordingly, the access to the markets of other countries for Belarusian drugs will be easier. The results of Belarusian inspections and national certificates will be recognized by all members of the organization, and the number of counter inspections will decrease.<br /><br />In 2012, the Belarusian Pharmaceutical Inspection applied for a preliminary assessment of its readiness to become a full member of this organization.<br /><br />This resulted in proposals and a corrective action plan, which is currently being worked upon.<div>
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Source: <a href="https://gmpnews.net/2017/08/belarus-plans-to-apply-for-the-membership-in-pics/" target="_blank">GMPnews</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comBelarus53.709807 27.95338900000001648.893959499999994 17.626240500000016 58.5256545 38.280537500000015tag:blogger.com,1999:blog-5861472110415643495.post-44023584942173825592017-07-31T22:23:00.000+03:002017-09-16T22:23:49.202+03:00Kazakhstan. 24 Pharmaceutical Manufacturers Are Allowed To Launch New Facilities<div dir="ltr" style="text-align: left;" trbidi="on">
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24 manufacturers of medicinal products and medical devices in Kazakhstan will be able to launch a new or upgrade their existing production facility as a result of guaranteed ten-year state order for pharmaceutical products.<br /><br />The companies were selected in an open tender for the conclusion of long-term contracts with TOO CK-Pharmacia (SK-Pharmacy LLP), the Single Distributor for procurement of medicines and medical devices.<br /><br />The guaranteed market outlet for pharmaceutical products through state orders for the period of ten years allows manufacturers to attract new investments in the pharmaceutical industry of Kazakhstan while finding the necessary resources to upgrade or build their pharmaceutical plants in accordance with GMP standards.<br /><br />In the tender announced on April 11, 2017, the manufacturers had the opportunity to state their intention to manufacture any of 772 medicinal products and 1367 medical devices. By the time of opening the bids, the organizers received 48 applications from 44 potential suppliers.<br /><br />Now, the winners will sign the long-term contracts for delivery of 523 drugs and 389 medical devices awarded following the tender.<br /><br />The companies will have five years to implement the projects, after which the manufacturers will have to start supplying high-quality and locally produced medicinal products and medical devices to the hospitals in Kazakhstan through the Single Distributor.<br /><br /><div>
Source: <a href="https://gmpnews.net/2017/07/24-pharmaceutical-manufacturers-in-kazakhstan-are-allowed-to-launch-new-facilities/" target="_blank">GMPnews</a></div>
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Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comKazakhstan48.019573 66.9236839999999848.019573 66.92368399999998 48.019573 66.92368399999998tag:blogger.com,1999:blog-5861472110415643495.post-32330367162441804882017-07-28T13:54:00.000+03:002017-09-11T13:59:25.233+03:00Ukraine Gives Transition Period For Introduction Of NEML<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi4rnOcnN70ph9w9F7qVgmFxDi2G9xWHkkdXwe3uVtPRIZg0r25943mXIPCVdLf5jBeMQvgo3A8U1wYt8W2-36X475V7RjwnIKDiMD9bdwbVEG0F8qRMbgjQ-nSkxLkFJ3EfysD6fk6iU_V/s1600/Eurovision-Kiev-Ukraine-things-to-do-919924.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="392" data-original-width="590" height="212" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi4rnOcnN70ph9w9F7qVgmFxDi2G9xWHkkdXwe3uVtPRIZg0r25943mXIPCVdLf5jBeMQvgo3A8U1wYt8W2-36X475V7RjwnIKDiMD9bdwbVEG0F8qRMbgjQ-nSkxLkFJ3EfysD6fk6iU_V/s320/Eurovision-Kiev-Ukraine-things-to-do-919924.jpg" width="320" /></a></div>
In March 2017 the Government introduced significantly revised and shortened NEML based on the 19th edition of WHO Model Essential Medicines List.<br />
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Initially, the NEML entered into force on July 1, 2017, restricting the list of procurable through tenders and reimbursable medicines. However, as of July 26, 2017, the Government introduced (by Resolution # 547) transition period for application of the new NEML.<br />
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<h2 style="text-align: left;">
TRANSITION FOR PUBLIC TENDERS</h2>
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<li><b>July 26 - August 31, 2017.</b> Public healthcare institutions and local governments may procure and/or initiate tenders to procure any medicines registered in Ukraine (including those not listed in the NEML). All tenders announced during this period may be completed under the rules in force on the date of the announcement.</li>
<li><b>September 1 - December 31, 2017.</b> Public healthcare institutions and local governments may only procure medicines registered in Ukraine, which are listed in the NEML.</li>
<li><b>After January 1, 2018.</b> Public healthcare institutions and local governments must fund 100% of medicines listed in the NEML according to the volumes defined based on specific MoH guidelines (yet to be adopted). Subject to full compliance with the said 100% coverage requirement, the purchasers will be allowed to procure medicines not listed in the NEML, with the preference to those listed in clinical standards/protocols.</li>
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The above restrictions do not apply to the centralized procurement procedures, which are currently conducted by the international organizations contracted by MoH (UNICEF, UNDP, Crown Agents).<br />
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<h2 style="text-align: left;">
REIMBURSEMENT</h2>
The Government also updated the NEML in part of dosages and forms of some of the already listed medicines. This shall extend the list of reimbursable medicines under the “Affordable Medicines” governmental program, as well as allow public procurement of the added dosages and forms. Maximum wholesale and retail markups of 10% and 15% respectively apply to reimbursable medicines.<br />
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<h2 style="text-align: left;">
FREE RETAIL MARKET</h2>
For the private retail sector, the new NEML remains in force as of March 25, 2017, and transition period does not apply. This means that maximum wholesale and retail markups of 10% and 25% respectively remain applicable to all NEML listed not reimbursable medicines.<br />
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Source: <a href="http://www.marchenkodanevych.com/node/222" target="_blank">MarchenkoDanevych</a></div>
Eugene Brovkohttp://www.blogger.com/profile/11403836886417419120noreply@blogger.comUkraine48.379433 31.16557990000001237.555531 10.511282900000012 59.203334999999996 51.819876900000011