Kazakhstan. Regulation of pharmaceutical export

The procedures of export of pharmaceutical products to the Republic of Kazakhstan (as well as registration of local production) include obligatory registration of the products at Ministry of Health (Committee of Pharmaceutical Control). The procedures to get the state registration are following:

1. Submission of the Application on registration of pharmaceutical products with enclosed confirmation of payment of state registration fee to the Committee of Pharmaceutical Control. The Application initialled by the head of the Department of the Committee of Pharmaceutical Control transfers to the department of experts’ work of National Center of Expertise of the Ministry of Health of RK (NCE).
2. The Applicant concludes the contract with NCE for carrying out expert examination.
3. The specialist of expert department accepts the Application for state registration, checks the availability of contract for expert examination, than issue the referral for payment. The referral for payment initials by specialist and head of department and goes to the account department. The account department prepare invoice within 5 working days.
4. After check the registration dossier, samples and standards of pharmaceutical products validity of samples, standards and storage mode all these goes to small achieve. The certificates of analyse is require for the given standards and samples. FYI: In case of failure to submit the all necessary document within 30 day the company must inform (in written form) about the term that is require for submission of all require papers. Otherwise the given pharmaceutical product will get a refusal in state registration. 
5. Primary expertise of documents and materials carry out within 20 days for registration of pharmaceutical product, 10 days in case of re-registration, and 5 days – for substance from the day of money in payment to the account of NCE. In case of positive finding of primary expertise the product sends for analytic expertise. 
6. Analytic expertise conducts out within 50 days, immunobiological products - 70 days. 
7. Special pharmaceutical expertise conducts by Pharmacopoeia Center (including expertise of technological normative document on control of quality and security, 40 days) within 90 days. 
8. Special pharmacological expertise conducts by Pharmacological Center within 90 days after getting the positive decision of pharmaceutical expertise. 
9. After passing of complete cycle of expert’s work the conclusion on safety, efficiency and quality of pharmaceutical product prepares within 20 days if registration, 10 days if re-registration  On the bases of the order of Chairman of Committee of Pharmaceutical Control the registration card issues.
10. The applicant receives following:

• Registration card with term within the given pharmaceutical product is allowed for  medical usage on the territory of the Republic of Kazakhstan. 
• Confirmed technical limitation document on control of quality and safety of the product. 
• Confirmed guidance for medical usage of pharmaceutical product in Russian and Kazakh languages.
• Confirmed package and labels design 
• Second exemplar of registration dossier

Sources:
Statistics Agency RK www.stat.kz
National Center of Expertise of the Ministry of Health of Kazakhstan www.dari.kz
SK-Parma http://www.sk-pharma.kz/