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 the Law of Ukraine “On Medicinal Products” medicinal products are allowed for use in Ukraine only after state registration.
The application for state registration of a 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, the manufacturer of said medicinal product, denomination of the product, a type of the 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:
1) Registration form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- 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 the 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;
- Certificate of suitability of monographs of European Pharmacopoeia (if available);
- written obligation of the applicant to ensure operation of adequate system to supervise safety of the medicinal product during its medical use including the territory of Ukraine;
- CV of qualified person responsible for pharmacovigilance;
- CV of contact person of qualified person responsible for pharmacovigilance with location in Ukraine;
- 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 trademark certificate in Ukraine (if available), etc.
2) Registration dossier in the format of the common technical document (CTD);
3) Samples of the medicinal product and standard samples (not required for medicinal products that has been registered in country which regulatory authorities apply high quality standards complying with standards recommended by WHO, particularly of EU Member States, Switzerland, UK, USA, Canada, Japan, Australia, Iceland, Lichtenstein).
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.
We would like to draw your attention to the fact that according to the Ukrainian legislation a foreign applicant must have a contact person of qualified person responsible for pharmacovigilance with location in Ukraine and provide this information in the registration dossier.
Besides, please note that the Ministry and State Expert Centre may request additional information and/or documents. It is individually for each particular registration.
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 examination of the registration dossier on a medicinal product should be conducted within 90-210 workdays depending on the type of a 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 the Law of Ukraine “On Medicinal Products” in case of registration of a 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 time frame for examination of the registration materials under the mentioned simplified procedure constitutes 10 working days without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice the procedure of the simplified state registration may last from 3 to 4 months without considering the time for preparation of responses to the remarks.
The Certificate about the state registration of a medicinal product in Ukraine is valid on the permanent basis, however, for 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 180 days before expiration of previous registration, but not earlier than 1 year. 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 and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.
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