Medicinal Product Registration
General Information

Medicinal products are introduced into civil circulation in the territory of the Russian Federation upon their registration by the appropriate authorized federal executive body.

According to the Federal Law of the Russian Federation dated April 12, 2010, No. 61-FZ "On the Circulation of Medicines," the following are subject to state registration:

  • All medicinal products intended for initial introduction into circulation in the Russian Federation.
  • Previously registered medicinal products that are manufactured in different dosage forms as per the list of medicinal forms, in a new dosage with proven clinical significance and efficacy.
  • New combinations of previously registered medicinal products.

According to the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 78:

Medicinal products intended for circulation in the general market of medicines within the Union or in the territory of one of the member states are subject to registration under these Rules.

  • From January 1, 2021, registration is only possible according to international EAEU rules. Registration certificates for medicinal products issued in accordance with the legislation of member states are valid until the expiration of their validity, but no later than December 31, 2025; and medicinal products registered under the legislation of member states must comply with the requirements of international treaties and acts constituting Union law by December 31, 2025.

State registration of medicinal products for medical use is carried out based on the results of medicine expert evaluation.

The expert evaluation of medicinal products includes:

  • Evaluation of documents submitted by the applicant for state registration of the medicinal product.
  • Evaluation of the proposed methods for quality control of the medicinal product and the quality of the samples provided using these methods.
  • Evaluation of the expected benefit versus the potential risk of the medicinal product.

Registration Certificate

Upon completion of the evaluation, a Registration Certificate for the medicinal product is issued, indicating the forms and dosages. The validity period of the registration certificate for a medicinal product registered for the first time in the reference state is 5 years. After this period, a perpetual registration certificate for the medicinal product is granted, provided its registration (re-registration) is confirmed.

Services and Stages:

  • Analysis of submitted documents.
  • Unification of documents according to registration rules based on the Decision of the EAEU Council No. 78 dated November 3, 2016.
  • Preparation of necessary documents, formation of a dossier (both paper and electronic), and submission of the dossier to the Ministry of Health of the Russian Federation.
  • Conducting user testing of the package insert.
  • Monitoring the expert evaluation and registration process (documentary and pharmaceutical expertise), providing consultations, and responding to inquiries from experts of the Ministry of Health of the Russian Federation and FGBU NC ESMHP.
  • Completion of the registration process, inclusion in the Register of Medicines, and obtaining the Registration Certificate.
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.
© ООО «ФармРегС»
Made on
Tilda