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State registration of medicinal products in Ukraine
Issues associated with the state registration of medicinal products are regulated by the Ukrainian Ministry of Health Protection. In accordance with Decree of the Cabinet of Ministers of Ukraine dated May 26, 2005 No. 376 with last amendments dated August 8, 2016 medicinal products are allowed for use in Ukraine only after state registration.
The application for state registration of medicinal product is filed to the Ukrainian Ministry of Health Protection. The application for registration of the medicinal product should contain general information about the applicant, manufacturer of the medicinal product, denomination of the product, type of product, pharmaceutical form, dosage, quantitative and qualitative formulation, including active ingredient and excipients, indications and contraindications, 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 copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers and GMP Certificate or Conclusion of Compliance to the GMP requirements for manufacturing site responsible for batch release of medicinal product issued by the State Administration of Ukraine on medicines and drugs control;
- copy of Registration Certificate issued by the competent authority of country of applicant and/or manufacturer or justification of its absence;
- list of countries where the product is registered;
- the Certificate of suitability of monographs of European Pharmacopoeia or Drug Master File for active substance (-s);
- written obligation of the applicant to ensure operation of adequate system to supervise safety of medicinal product during its medical use including the territory of Ukraine;
- CV of qualified person responsible for pharmacovigilance;
- letter of the applicant with confirmation that rights of third party are not violated due to registration of the medicinal product;
- copies of patents for the invention, utility model or industrial design, which are valid in Ukraine (in the case of state registration of medicinal product related to the intellectual property objects);
- copy of trade mark in Ukraine (if available), etc.
2) Registration dossier in the format of the common technical document (CTD);
3) Samples of medicinal product and packaging thereof, etc. (if requested during examination);
4) Standard samples for the medicinal product (if requested during examination).
Please note that in case of registration of the original (new) medicinal product it is necessary to provide the full registration dossier including the data on the preclinical and clinical studies and examination thereof.
Besides, please note that the Ministry and State Expert Centre may request additional information and/or documents. It is individually for each particular registration case.
In case of need the materials for state registration of medicinal product may be sent by the State Centre for additional examination that is conducted in research institutions authorized by the Ministry of Health Protection. The results of additional examination are forwarded to the State Centre for review.
Based on the results of examination the State Centre makes conclusions in respect of efficiency, safety and quality of the medicinal product and recommends or does not recommend it for state registration. On the basis of these conclusions provided by the State Centre the Ministry of Health Protection makes a decision in respect of registration of the medicinal product or rejects registration thereof. The registration Certificate is issued within about 60 days from the date of acceptance of the positive decision.
According to the Ukrainian legislation the procedure of state registration of medicinal product should be conducted within 90-210 workdays depending on the type of the medicinal product to be registered 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 may last from 9 to 15 months without considering the time for preparation of responses to the remarks.
According to recent amendments into the Law of Ukraine “On Medicinal Products” from May 31, 2016, in case of registration of the medicinal product which has been already registered in the USA, Canada, Australia, Japan, Switzerland or the European Union according to the centralized procedure said product is not subject to the above-mentioned examination. The registration certificate shall be issued with consideration of the copy of the registration dossier for said medicinal product which has been already registered in the USA, Canada, Australia, Japan, Switzerland or the European Union according to the centralized procedure and upon verification of correspondence of the instruction for use and methods of quality control to the registration materials. Besides, said documents should be accompanied by written obligation of the manufacturer to produce said product for delivery to Ukraine on the same production facilities used in the production of medicinal product intended for use in the United States, Switzerland, Japan, Australia, Canada or the states - members of the European Union. This written obligation can be replaced by the Conclusion of Compliance to the GMP requirements for manufacturing site responsible for batch release of medicinal product issued by the State Administration of Ukraine on medicines and drugs control. The term for approval of a decision on registration or refusal to register thereof under the mentioned simplified procedure is reduced to 10 working days.
The Certificate about the state registration of medicinal product in Ukraine is valid on the permanent basis, however, for the medicinal products that are first registered in Ukraine within 5 years it is necessary to renew the registration. 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 9 months without considering the time for preparation of responses to the remarks. The renewal procedure does not require checking the quality control methods, however, it will be necessary to provide a critical discussion of the current benefit/risk balance for the product on the basis of the PSUR data and safety/efficacy data accumulated since the first registration, making reference to relevant new information in the public domain.
In order we could provide you with the information on costs associated with the registration of medicinal products in Ukraine together with the detailed information required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.