Medicinal Products Registration in Ukraine

The state registration of medicinal products in Ukraine is regulated by the Ministry of Health of Ukraine in accordance with the Law of Ukraine “On Medicinal Products”. Pharmaceutical products may be placed on the Ukrainian market only after obtaining state registration from the competent authorities. This procedure confirms the quality, safety, and efficacy of a medicinal product before it can be distributed and used in Ukraine.

Key registration facts

210 / 10

Working days

Official timeframe for substantive examination: 90–210 days for standard and 10 days for simplified procedures

9–15

Months

Average practical duration for state registration; excluding time for preparing responses to SEC requests

CPPV

Mandatory

A foreign applicant must appoint a local contact person responsible for pharmacovigilance located in Ukraine

5 / ∞

Validity

The initial registration certificate is valid for 5 years; after renewal, it is granted for an unlimited term

What is required to register a medicinal product

The registration of a medicinal product in Ukraine is conducted in several stages, each requiring submission of specific documents to the competent authorities. To initiate the registration procedure, it is necessary to submit an application for state registration of a medicinal product to the Ministry of Health of Ukraine (the MoH of Ukraine) for a preliminary examination. Upon passing the preliminary examination, it is necessary to submit the following to the State Expert Center (the SEC) of the MoH of Ukraine.

1. Registration form accompanied by the following supporting documents (in paper form):
   • Legalized Power of Attorney from the applicant to the representative;
   • Certified copies of Manufacturer’s Authorizations for all manufacturing sites involved in the manufacturing process issued by the competent authorities of the countries-manufacturers and a GMP Certificate or a Conclusion of Compliance to the GMP requirements for the manufacturing site responsible for batch release of the medicinal product issued by the State Service of Ukraine on Medicines and Drugs Control (the SMDC) (the procedure of issuance of these documents is conducted in parallel with the procedure of registration after submitting the Application for registration);
   • Copy of a Registration Certificate or Certificate of a Pharmaceutical Product (Free Sale Certificate) issued by a competent authority of the applicant’s and/or manufacturer’s country, 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 in the territory of Ukraine;
   • CV of a qualified person responsible for pharmacovigilance;
   • CV of a contact person responsible for pharmacovigilance (with location in Ukraine);
   • Letter from the applicant with confirmation that the rights of third parties are not violated due to registration of the medicinal product;
   • Copies of patents for an invention, utility model or industrial design, which are valid in Ukraine (in case of state registration of a medicinal product related to intellectual property objects);
   • Copy of a trademark certificate in Ukraine (if available), etc.
2. eCTD Modules 1-5;
3. Samples of the medicinal product and standard samples (not required for medicinal products already registered in countries whose regulatory authorities apply high-quality standards recommended by the World Health Organization, including the EU Member States, Switzerland, the United Kingdom, the United States, Canada, Japan, Australia, Iceland, and Liechtenstein).

According to Ukrainian legislation, a foreign applicant must appoint a contact person responsible for pharmacovigilance (CPPV) located in Ukraine and include this information in the registration dossier. Our firm provides services of acting as a CPPV in Ukraine and supporting compliance with pharmacovigilance requirements.

Duration of registration process

Under Ukrainian legislation, the substantive examination of a medicinal product registration dossier is conducted within 90–210 working days, depending on the type of medicinal product. This period does not include the time required to prepare responses to official requests issued during the examination, if any. However, in accordance with usual practice, depending on the completion of the provided materials, the scope of documentation, the number of requests from the SEC, and other factors, the state registration procedure may last from 9 to 15 months, not including a time for preparation of the responses to the official requests.

Simplified registration of medicinal products

According to the Law of Ukraine “On Medicinal Products”, a medicinal product that has already been registered in the United States, Canada, Australia, Japan, Switzerland, or the European Union under the centralized procedure may qualify for a fast-track registration procedure in Ukraine.

For said procedure the registration dossier should be provided in paper form. The Registration Certificate shall be issued with consideration of a copy of the registration dossier on said medicinal product that has been already registered in one of the mentioned countries and upon verification of correspondence of the instruction for use and methods of quality control to the registration materials.

In addition, the documentation must be accompanied by a written obligation from the manufacturer confirming that the medicinal product intended for import into Ukraine will be produced at the same manufacturing facilities used for the production of the product supplied to the market of the reference country. This written obligation can be replaced with a Conclusion of Compliance of the medicinal products manufacturing conditions with the GMP requirements for the manufacturing site responsible for batch release of the medicinal product issued by the SMDC.

The examination of registration materials under the simplified procedure is conducted within 10 working days. This period does not include the time required to prepare responses to official requests, if any. However, in practice the simplified state registration procedure may take approximately 3 to 4 months, depending on the completeness of the submitted documentation and the time required to respond to official requests, if any.

Validity term and renewal

A certificate of state registration for a medicinal product first registered in Ukraine is issued for a period of five years. After this initial period, the registration may be renewed for an unlimited term.

The renewal procedure may be initiated no later than 180 days before the expiration of the current registration, but not earlier than one year before its expiry. In practice, the renewal procedure usually takes about nine months, excluding the time required to prepare responses to official requests, if any.

The renewal process does not involve verification of the quality control methods. However, the applicant must submit a critical evaluation of the current benefit–risk balance of the medicinal product based on PSUR data and safety and efficacy information accumulated since the initial registration, with reference to relevant new information available in the public domain.

For more detailed information on the costs associated with registration of medicinal products in Ukraine, the lists of documents required for submission, etc. please contact our specialists.