Issues associated with the state registration of active pharmaceutical ingredients are regulated by the Ukrainian Ministry of Health Protection. According to the Law "On Medicinal Products", 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.
Requirements for registration
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 an active pharmaceutical ingredient is filed to the Ukrainian Ministry of Health Protection. The application for registration of the active pharmaceutical ingredient should contain general information about the applicant, the manufacturer of said API, product form, shelf-life, storage conditions, etc.
Required information and documents
1) Registration form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- certified copy of the authorization document for industrial production of API issued by the competent authority of country-manufacturer (if available);
- Certificate of suitability of monographs of European Pharmacopoeia (if available);
- 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 trademark certificate in Ukraine (if available).
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).
Procedure of registration of an API
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.
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.
Duration of registration process
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.
Validity term and renewal
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 not later than 180 days before expiration of previous registration, but not earlier than 1 year. The usual renewal procedure lasts for 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 and list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.
