State registration of drugs
The state registration of drugs is carried out within the framework of the Federal Law No. 61 “On Circulation of Drugs”.
According to Art. 13 registration is subject to:
1) all medicines to be put into circulation for the first time in the Russian Federation;
2) medicines registered previously, but produced in other dosage forms according to the list of names of dosage forms, in a new dosage with proof of its clinical relevance and effectiveness;
3) new combinations of previously registered medicines.
State registration is not subject to:
1) Drugs manufactured by pharmaceutical organizations, veterinary pharmaceutical organizations, individual entrepreneurs
2) Drugs purchased by individuals outside the Russian Federation and intended for personal use;
3) Drugs imported into the Russian Federation to provide medical care on the vital indications of a particular patient on the basis of a permit issued by the authorized federal executive body;
4) Drugs imported for clinical trials of medicinal products and (or) examination of medicinal products for state registration of medicinal products;
5) Pharmaceutical substances;
6) Radiopharmaceutical drugs manufactured directly in medical organizations
(7) Drugs produced for export.
State registration is not allowed for:
1) Drugs, which differ from each other in the qualitative composition of active substances, under the same trade name;
2) One drug submitted for state registration in respect of the same holder or holder of the registration certificate in the form of two or more drugs under different trade names.
- Preparation of the registration dossier.
- Submission to the Ministry of Health of the Russian Federation
- Examination of reliability and completeness of documents — 5 working days
- Examination of the quality of drug and examination of the ratio of expected benefit to the possible risk of drug use — 110 working days
- Issuance of registration certificate (RC)
Additional information may be requested at each stage of the examination. Term of elimination of the request — 90 working days.
In addition, in the application, you can specify the need to modify the registration procedure (the need for an accelerated registration procedure, examination of documents in the registration of orphan drugs). Read more about this in the relevant articles.
Terms and fees:
- The registration period is 160 working days, and does not include the deadline for the removal of requests.
- Fee for examination of the quality of the medicinal product and examination of the relation of the expected benefit to the possible risk of using the medicinal product for medical use in its state registration – 325 000 rubles;
- The fee for issuing the registration certificate of the medicinal product – 10 000 rubles;
- Federal Law “On Circulation of Drugs” dated 12.04.2010 N 61-FZ
- Order of the Ministry of Health of the Russian Federation dated 21.09.2016 N 725n “On Approval of Administrative Regulations of the Ministry of Health of the Russian Federation on Provision of Public Services in the State Register medicinal products 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 the state registration of medicines and registration of medicines for the purpose of forming a common market of medicines within the framework of the Eurasian Economic Union
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