Ukraine. Procedure of state (re-) registration of medical immunobiological drugs
The current legislation of Ukraine defines medical immunobiological drugs (hereinafter MIBD) as vaccines, detoxified bacterial products, immunoglobulin, serums, bacteriophages, interferon, bacterial preparation and other medicinal products used in medical praxis for specific prevention and diagnostics of infectious, parasitical illnesses and allergic conditions and made by means of organisms strain’s and eukaryote cells’ cultivation, extraction of substances from biological tissue and blood, including human, animal and plan tissue and blood (allergens), use of recombinant DNA technology, monoclonal antibody technology, reproduction of living agents in animal embryos or organisms, and specifies as MIBD manufacturer a company carrying out at least one of MIBD manufacturing stages, including packing.
Only such MIBD which comply with requirements of state and international standards and are registered in Ukraine, included to the state register and have passed quality control according to procedure stipulated by the MHC of Ukraine can be used in medical practice in Ukraine.
The state (re-)registration of MIBD is conducted by the MHC of Ukraine.Expert examination of MIBD submitted for state (re-)registration has following stages:
Initial expert examination of registration materials is carried out by the MHC of Ukraine. Preliminary and specialized expert examination of registration materials and laboratory analysis of samples is carried out by the State Enterprise «Centre of Immunobiological Drugs» upon submission of the MHC of Ukraine.
Upon results of expert examinations, researches and MIBD quality control the Centre shall execute a motivated conclusion on efficacy, safety and quality of MIBD according to which it recommends MIBD for state (re-)registration.
Decision on state registration, re-registration, amendments to registration materials and/or Certificate on state registration of MIBD or on refusal in such shall be made by the MHC of Ukraine on the basis of a motivated conclusion on efficacy, safety and quality of MIBD.
In case of decision making on registration, re-registration, amendments to registration materials and/or Certificate on state registration of MIBD the MHC of Ukraine shall approve a package insert for MIBD, package graphic design, analytical-normative documentation and approves the normative-technical documentation.
The validity period of the state registration of MIBD is up to 5 years. After expiration of this term MIBD are subject to re-registration. Within period of validity of the state registration certificate the applicant shall be liable for quality of the registered MIBD and shall provide information on any changes and amendments regarding manufacturing and quality control of MIBD.
The expert examination of changes shall be carried out in the same procedure as the expert examination of registration materials during the (re-)registration of MIBD. Each single change is subject to expert examination, even if there are several simultaneous changes. The term of state (re-)registration of MIBD and expert examination of materials which have been amended within the validity term of the state registration certificate and require new registration of MIBD shall not exceed 210 calendar days.
Expert examination of changes in order to carry out state registration of a patented MIBD which is licensed (registered) in the European Economic Community under centralized procedure, MIBD generics, materials for state re-registration of MIBD, expert examination of materials on amendments of Type I and II occurring within the validity term of the state registration certificate shall not exceed 90 calendar days.
It shall be noted that aforementioned time of expert works does not include time when documents have been amended by the application and the time for quality control and research.
Certificate on state registration of MIBD in Ukraine which pursuant to the legislation confirms state registration of medical immunobiological drug in Ukraine is issued to the applicant after payment of the registration fee.
Fee for issuance of the certificate confirming MIBD state registration shall be paid by the applicant in UAH in the amount equivalent to 1000 EUR for each pharmaceutical form, 100 EUR for each next dose and 100 EUR for each next package.
Fee for issuance of the certificate confirming state registration of MIBD used in medical practice for diagnostic purposes shall be paid by the applicant in UAH in the amount equivalent to 500 EUR for each pharmaceutical form, 50 EUR for each next dose and 50 EUR for each next package of MIBD.
Fee for re-registration of MIBD shall be paid by the applicant in the amount of 50% of the certificate issuance fee.
For issuance of the certificate confirming state registration of MIBD included to the list of diagnostic MIBD used for medical purposes for diagnostics of infectious diseases (hereinafter – the List) as determined by the MHC of Ukraine, volume of import (customs value) and sale of which does not exceed amounts stated in the List for each drug under single nosological units of human infectious diseases, the applicant shall pay a fee in UAH in the amount equivalent to 100 EUR for each pharmaceutical form.
The state registration certificate on MIBD included to the list of diagnostic MIBD used for diagnostics of infectious diseases (hereinafter – the List) as determined by the MHC of Ukraine is valid 1 year. One month prior to the end of the validity period of the state registration certificate the applicant shall submit an application on prolongation of the state registration to the MHC of Ukraine. If the volume of import (customs value) and sale of MIBD registered according to the List is not exceeded, the validity term of the state registration certificate shall be prolonged free of charge, and if the volume of import (customs value) and sale of MIBD registered according to the List is exceeded, the validity term of the certificate shall be prolonged provided payment of the difference between the actual amount and amount of the certificate issuance fee for MIBD not included to the List.
For issuance of the certificate confirming the state registration of MIBD packed «in bulk» the applicant shall pay a fee in UAH in the amount equivalent to 25 EUR for each pharmaceutical form and 25 EUR for each next package. Within the validity term of the MIBD state registration certificate the applicant shall be obliged to provide to the MHC of Ukraine information on side and nonspecific effects of the drug:
Once in 6 months within first 2 years after MIBD registration;
thereafter – annually
Total and selective quality control of immunobiological drugs manufactured in Ukraine and incoming quality control of imported immunobiological drugs is carried out by the MHC of Ukraine.
Only such MIBD which comply with requirements of state and international standards and are registered in Ukraine, included to the state register and have passed quality control according to procedure stipulated by the MHC of Ukraine can be used in medical practice in Ukraine.
The state (re-)registration of MIBD is conducted by the MHC of Ukraine.Expert examination of MIBD submitted for state (re-)registration has following stages:
- primary expert examination of registration materials and state (re-)registration application for MIBD with respect to motivated conclusion of the possibility of state (re-)registration of the medicinal product from the point of view of its belonging to medical immunobiological drugs, execution of materials;
- preliminary expert examination as to complexity of registration materials on MIBD analysis of which allows to decide on possibility of acceptation of documents for (re-) registration or refuse in case of lack (non-compliance) of documents and registration materials;
- specialized expert examination of the registration file, results of MIBD quality control conducted in order to give motivated conclusion as to efficacy and safety of MIBD.
Initial expert examination of registration materials is carried out by the MHC of Ukraine. Preliminary and specialized expert examination of registration materials and laboratory analysis of samples is carried out by the State Enterprise «Centre of Immunobiological Drugs» upon submission of the MHC of Ukraine.
Upon results of expert examinations, researches and MIBD quality control the Centre shall execute a motivated conclusion on efficacy, safety and quality of MIBD according to which it recommends MIBD for state (re-)registration.
Decision on state registration, re-registration, amendments to registration materials and/or Certificate on state registration of MIBD or on refusal in such shall be made by the MHC of Ukraine on the basis of a motivated conclusion on efficacy, safety and quality of MIBD.
In case of decision making on registration, re-registration, amendments to registration materials and/or Certificate on state registration of MIBD the MHC of Ukraine shall approve a package insert for MIBD, package graphic design, analytical-normative documentation and approves the normative-technical documentation.
The validity period of the state registration of MIBD is up to 5 years. After expiration of this term MIBD are subject to re-registration. Within period of validity of the state registration certificate the applicant shall be liable for quality of the registered MIBD and shall provide information on any changes and amendments regarding manufacturing and quality control of MIBD.
The expert examination of changes shall be carried out in the same procedure as the expert examination of registration materials during the (re-)registration of MIBD. Each single change is subject to expert examination, even if there are several simultaneous changes. The term of state (re-)registration of MIBD and expert examination of materials which have been amended within the validity term of the state registration certificate and require new registration of MIBD shall not exceed 210 calendar days.
Expert examination of changes in order to carry out state registration of a patented MIBD which is licensed (registered) in the European Economic Community under centralized procedure, MIBD generics, materials for state re-registration of MIBD, expert examination of materials on amendments of Type I and II occurring within the validity term of the state registration certificate shall not exceed 90 calendar days.
It shall be noted that aforementioned time of expert works does not include time when documents have been amended by the application and the time for quality control and research.
Certificate on state registration of MIBD in Ukraine which pursuant to the legislation confirms state registration of medical immunobiological drug in Ukraine is issued to the applicant after payment of the registration fee.
Fee for issuance of the certificate confirming MIBD state registration shall be paid by the applicant in UAH in the amount equivalent to 1000 EUR for each pharmaceutical form, 100 EUR for each next dose and 100 EUR for each next package.
Fee for issuance of the certificate confirming state registration of MIBD used in medical practice for diagnostic purposes shall be paid by the applicant in UAH in the amount equivalent to 500 EUR for each pharmaceutical form, 50 EUR for each next dose and 50 EUR for each next package of MIBD.
Fee for re-registration of MIBD shall be paid by the applicant in the amount of 50% of the certificate issuance fee.
For issuance of the certificate confirming state registration of MIBD included to the list of diagnostic MIBD used for medical purposes for diagnostics of infectious diseases (hereinafter – the List) as determined by the MHC of Ukraine, volume of import (customs value) and sale of which does not exceed amounts stated in the List for each drug under single nosological units of human infectious diseases, the applicant shall pay a fee in UAH in the amount equivalent to 100 EUR for each pharmaceutical form.
The state registration certificate on MIBD included to the list of diagnostic MIBD used for diagnostics of infectious diseases (hereinafter – the List) as determined by the MHC of Ukraine is valid 1 year. One month prior to the end of the validity period of the state registration certificate the applicant shall submit an application on prolongation of the state registration to the MHC of Ukraine. If the volume of import (customs value) and sale of MIBD registered according to the List is not exceeded, the validity term of the state registration certificate shall be prolonged free of charge, and if the volume of import (customs value) and sale of MIBD registered according to the List is exceeded, the validity term of the certificate shall be prolonged provided payment of the difference between the actual amount and amount of the certificate issuance fee for MIBD not included to the List.
For issuance of the certificate confirming the state registration of MIBD packed «in bulk» the applicant shall pay a fee in UAH in the amount equivalent to 25 EUR for each pharmaceutical form and 25 EUR for each next package. Within the validity term of the MIBD state registration certificate the applicant shall be obliged to provide to the MHC of Ukraine information on side and nonspecific effects of the drug:
Once in 6 months within first 2 years after MIBD registration;
thereafter – annually
Total and selective quality control of immunobiological drugs manufactured in Ukraine and incoming quality control of imported immunobiological drugs is carried out by the MHC of Ukraine.
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