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State registration of APIs in Ukraine
Issues associated with the state registration of active pharmaceutical ingredients are regulated by the Ukrainian Ministry of Health Protection. According to the Law “On Medicine”, Article 11 during manufacturing of medicinal products should be used only those active pharmaceutical ingredients that are allowed for usage by the corresponding state authority.
It is possible to register an active pharmaceutical ingredient together with the medicinal product that contains said active pharmaceutical ingredient or in a separate registration.
The application for state registration of active pharmaceutical ingredient is filed to the Ukrainian Ministry of Health Protection. The application for registration of active pharmaceutical ingredient should contain general information about the applicant, manufacturer, product form, shelf-life, storage conditions, etc.
The provided application materials are subject to the primary examination by the Ministry. According to the results of said examination the substantive examination is carried out by the Ukrainian State Expert Centre. For conducting the substantive examination it is necessary to provide the following documents and information:
1) Registration form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- the certified copy of the authorization document for industrial production of API issued by the competent authority of country-manufacturer (if available);
- the Certificate of suitability of monographs of European Pharmacopoeia (if available) or written consent for use of Drug Master File (in deliberate form) from API manufacturer;
- copies of patents for the invention, utility model or industrial design, which are valid in Ukraine (in the case of state registration of API related to the intellectual property objects);
- copy of trade mark in Ukraine (in the presence).
2) 1 Certificate of Analysis from API manufacturer;
3) Drug Master File (DMF) for API or registration dossier in the format of the section 3.2.S of common technical document (CTD).
Based on the results of examination the State Centre makes conclusions in respect of quality of the active pharmaceutical ingredient and recommends or does not recommend it for state registration. On the basis of this conclusion provided by the State Centre the Ministry of Health Protection makes a decision in respect of registration of the API or rejects registration thereof.
According to the Ukrainian legislation the procedure of state registration of API should be conducted within 90 workdays without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the State Centre and other factors the procedure of state registration of active pharmaceutical ingredient in Ukraine may constitute about 5-7 months without considering the time for preparation of responses to the remarks.
The Certificate about the state registration of a pharmaceutical substance in Ukraine is valid for 5 years and after that it is necessary to renew it each time for the next 5 years. The procedure of the renewal of the registration may be initiated no later than 90 days before expiration of previous registration. The usual renewal procedure lasts within about 3-4 months.
In order we could provide you with the information on costs associated with the registration of API in Ukraine together with the detailed information required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.