General information about the state registration of pharmaceutical products in Russia

Grounds of drug registration

Russian law allows the use of the medicinal products by citizens of the Russian Federation only if they are registered by the authorized executive body.

State registration of pharmaceutical products is required in the following cases:

1. In case of changes to the registered dosage or to the dosage form of the pharmaceutical products.
2. When the pharmaceutical products previously registered are produced in new combinations.
3. In case of recovery of the pharmaceutical products.
4. For original medicines and medicinal products.

Drug registration process in Russia.

Drugs for medical purposes can be registered according to the results of drug experts, and the ethical possibility of clinical drug testing. For veterinary purposes, following the results of the pharmaceutical product expert appraisal, the drug can be registered by the state bodies for veterinary application.
Drug registration shall be performed by the authorized federal executive body. The registration period takes up to 160 business days from the date of application for the drug state registration to be accepted.This period covers the time required for re-expertise of the pharmaceutical product and an ethical review according to Article 25 of the current Federal Law.

Registration period of drugs

It starts as soon as the application statement for drug registration is submitted to the body. It is important that all necessary documents are included with the application statement. This period ends only when the registration certificate for drug is issued.
After the time provided for the state registration of drug is over, any time used for clinical testing is not considered.

Substances that cannot be registered

Items not subject to the state registration:

1. Drugs produced for export only.
2. Drug raw materials.
3. Pharmaceutical products bought abroad for personal use.
4. Radiopharmaceutical drugs produced by medical entities in compliance with the requirements of the authorized federal executive body.
5. Pharmaceutical products produced by pharmaceutic and vet enterprises, or by individual entrepreneurs having a license for pharmaceutical activity on prescriptions for medicinal products and upon request of medical or veterinary organizations.

The following 2 items cannot pass the state registration of drugs:

1. Different pharmaceutical products under the same trade name.
2. Medicinal products produced by a manufacturer as two different trade names, and applied for drug registration as two or more medicinal products.