In accordance with the Law of the Russian Federation "On circulation of Medicinal Products" of April 12, 2010, Article 45 "pharmaceutical substances that are included into the State register of medicinal products should be used during manufacturing of medicinal products".
Possible ways of registration of an API
According to the law of Russia, two possible ways of inclusion of pharmaceutical substances for human or veterinary use into State register are stipulated, namely:
- State registration of a pharmaceutical substance in the composition of the medicinal product for human or veterinary use - within the frame of registration of the medicinal product. In this case it is possible to use the pharmaceutical substance only for manufacturing of said medicinal product. Examination of quality of a pharmaceutical substance is conducted during registration of the medicinal product;
- State registration of a pharmaceutical substance used for sale - within the frame of the separate registration procedure.
Registration of pharmaceutical substances for human or veterinary use, i.e. inclusion of the substance into the State Register, not within registration of the medicinal product is possible on condition that the examination of quality is carried out in respect of such substance. Inclusion of the pharmaceutical substance in the State Register allows the use, importation and sale of said substance in the territory of the Russian Federation.
What is required for registration
For conducting the procedure of inclusion of the pharmaceutical substance into the State Register it is necessary to provide the following to the authorized body:
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
- copies of Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in manufacturing process issued by the competent Authority of the Russian Federation (the state procedure of issuance of these documents should be started before submitting the Application for registration);
- legalized copy of registration certificate issued by the authorized organ of applicant and/or manufacturer or justification of its absence.
2) Master file containing the general information about the pharmaceutical substance for human or veterinary use (including information on manufacturing technique, development of manufacturing process, specifications, quality control, stability, shelf-life, etc.).
3) Samples of pharmaceutical substance and standard samples.
Duration of registration process
According to the Russian legislation the procedure of state registration of pharmaceutical substance used for sale should be conducted within 75 workdays without considering the time for delivery of samples to the authorized body and 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 competent authority and other factors the procedure of state registration of pharmaceutical substance in the Russian Federation may constitute about 5-7 months without considering the time for preparation of responses to the remarks.
Validity term and renewal
Registration of a pharmaceutical substance used for sale in the Russian Federation, i.e. inclusion of the substance in the State Register, is valid on the permanent basis, however, in case of absence of the substance in the market of the Russian Federation for more than 3 years, it is excluded from the State Register.
In order we could provide you with the information on costs associated with the registration of API in Russia 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.