Pharmaceuticals for human use registration in Russia
According to the definition of the Federal Law "On the Circulation of Medicines" No. 61, medicines are called:
substances or combinations thereof that come into contact with the human or animal body, penetrate into organs, tissues of the human or animal body, used for prevention, diagnosis (with the exception of substances or combinations thereof that do not come into contact with the human or animal body), disease treatment, rehabilitation, to preserve, prevent or terminate pregnancy, and obtained from blood, blood plasma, organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies. Medicines include pharmaceutical substances and drugs;
Pharmaceutical substance (PhS) is a medicinal product in the form of one or more active substances with pharmacological activity, regardless of the nature of origin, which is intended for the production, manufacture of medicines and determines their effectiveness;
In the Russian Federation, pharmaceutical substances are subject to registration according to national requirements (entry into the state register of Medicines - GRLS), if they are planned to be imported, for example, for further production of medicines.
The amount of the state fee for entering into the GRLS is 253,000 rubles.
The timeline for reviewing the dossier on the PhS in the regulatory authorities is 2 months + 90 working days to respond to the request.
Drugs are medicines in the dosage forms used for the prevention, diagnosis, treatment of the disease, rehabilitation, preservation, prevention or termination of pregnancy;
Starting from 2021, medicines are subject to registration only according to the requirements of the EAEU.
The amount of state fees for the registration of LP is:
1) For the examination of a drug for medical use during its registration - 325,000 rubles.
2) For the issuance of a registration certificate of a medicinal product for medical use - 10,000 rubles.
The period of registration and examination of a drug in the reference state should not exceed 140 working days from the date of filing an application for registration of a medicinal product to the date of issuance of the registration certificate.
The reference state is a member State of the EAEU that prepares an expert report on the assessment of the safety, effectiveness and quality of a drug based on its examination.
References:
Federal Law No. 61-FZ of 12.04.2010 (as amended on 08.08.2024) "On the circulation of medicines"
Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (as amended on 05/29/2024) "On the Rules for registration and examination of medicines for medical use"
The Tax Code of the Russian Federation Article 333.32.1. The amount of the state fee for the commission of actions by the authorized federal executive body in the implementation of state registration of medicines and registration of medicines for medical use in order to form a common market of medicines within the Eurasian Economic Union
