Issues associated with the state registration of medicinal products are regulated by the Ministry of Health of Ukraine. In accordance with the Law of Ukraine “On Medicinal Products”, medicinal products are allowed for use in Ukraine only after state registration thereof.
In order to initiate a registration procedure, it is necessary to submit an application for state registration of a medicinal product to the Ministry of Health of Ukraine (MoH of Ukraine). The application should contain general information about the applicant, the manufacturer of said medicinal product, denomination of the product, a type of the product, its pharmaceutical form, dosage, quantitative and qualitative formulation, including active ingredient and excipients, indications and contraindications, storage conditions, etc.
WHAT IS REQUIRED
Registration of a medicinal product is conducted in several stages, each of which involves submission of specific documents. In order to register a medicinal product it is necessary to submit the following:
1) Registration form with the attached documents:- 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 competent authorities of countries-manufacturers and a GMP Certificate or Conclusion of Compliance to the GMP requirements for a manufacturing site responsible for batch release of the medicinal product issued by the State Service of Ukraine on Medicines and Drugs Control (SMDC);
- copy of a Registration Certificate or Certificate of a Pharmaceutical Product (Free Sale Certificate) issued by a competent authority of country of applicant/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 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 of the applicant with confirmation that 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) 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 have been registered in a 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).
Also, according to the Ukrainian legislation a foreign applicant must have a contact person responsible for pharmacovigilance (CPPV) with location in Ukraine and provide this information in the registration dossier. Our company provides services on acting as a CPPV in Ukraine.
REGISTRATION PROCEDURE
As an initial step, application materials should be submitted to the MoH of Ukraine for a preliminary examination. Upon passing the preliminary examination, the materials are subject to the substantive examination by the State Expert Center of the MoH of Ukraine.
Based on the results of the substantive examination the State Expert Center makes conclusions in respect of efficiency, safety and quality of a medicinal product and recommends or does not recommend it for state registration. Taking into account the recommendation of the State Expert Center the Ministry of Health either makes a decision to register the medicinal product or rejects registration thereof. A Registration Certificate is issued within about 60 days from the date of the positive decision.
Duration of registration process
According to the Ukrainian legislation, the substantive examination of a registration dossier on a medicinal product should be conducted within 90-210 working days depending on the type of a medicinal product to be registered, without consideration of the time for preparation of responses to requests. However, in accordance with the usual practice, depending on the completion of provided materials and scope of documentation, number of requests of the State Expert Center and other factors, the procedure of state registration may last from 9 to 15 months without consideration of the time for preparation of responses to requests.
Simplified registration of medicinal products
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, such product is not subject to the standard examination. A Registration Certificate shall be issued with consideration of a copy of the registration dossier for said medicinal product which 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. Besides, said documents should be accompanied by a written obligation of the manufacturer to produce said product for import to Ukraine at the same production facilities that are used in the production of the medicinal product intended for the market of the country of the referenced registration. This written obligation can be replaced with a Conclusion of Compliance of the medicinal products manufacturing conditions with the GMP requirements for manufacturing site responsible for batch release of the medicinal product issued by the SMDC.
The time frame for examination of the registration materials under the mentioned simplified procedure constitutes 10 working days without consideration of the time for preparation of responses to requests. However, in accordance with the usual practice, the procedure of simplified state registration may last from 3 to 4 months without consideration of the time for preparation of responses to requests.
Validity term and renewal
A Certificate about the state registration of a medicinal product in Ukraine is valid on the permanent basis. However, it is necessary to renew the registration of medicinal products that are first registered in Ukraine within 5 years. The procedure of renewal of the registration may be initiated no later than 180 days before expiration of previous registration, but not earlier than 1 year. Normally, renewal procedure lasts for about 9 months without consideration of the time for preparation of responses to requests. 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 PSUR data and safety/efficacy data accumulated since the first registration, making reference to relevant new information in the public domain.
For more detailed information, including on the costs associated with registration of medicinal products in Ukraine, list of documents required for submission, sample of the Power of Attorney for execution, etc. please contact our specialists.
