The procedure for entering into civil circulation of medicines for medical use.

Posted on Monday July 6th, 2020 by beawire

Since November 2019, the Resolution of the Government of the Russian Federation No. 1510, which defines the new order of entry of the drugs into civil circulation, came into force. Previously, drug release required obtaining a declaration of conformity or certificate of conformity. The batch of the drug was checked for compliance with the quality indicators specified in the regulatory documentation on the drug. Based on the quality control, a test report was issued in the accredited laboratory, followed by a declaration/certificate of conformity. It must be said that such a certification procedure was, in the opinion of many experts, a formal one.

Current procedure of entry of drugs into civil circulation includes Roszdravnadzor participation in the process of drug release. Now “Before entering into civil circulation of each series or each batch of the drug, manufacturers of drugs and companies that import them into Russia will have to provide Roszdravnadzor with the documents confirming the quality of the drug or certifying compliance of the drug with the requirements established at its state registration”, – it is reported on the website of the Government of the Russian Federation. The procedure does not apply to immunobiological drugs.

Tests of the series of drugs for compliance with the requirements of the regulatory documentation are now carried out with the involvement of testing laboratories of federal institutions (FGBI “IMCEUAOSMP” Roszdravnadzor (11 branches); FGBI “NTSESMP” of the Ministry of Health of Russia). At the same time, in order to assess the quality of drugs, federal agencies have the right to send the samples for testing to other laboratories accredited in the national accreditation system.

It should be said that in practice, every distributor importing the drug into the territory of the Russian Federation needs to check each batch of the drug by at least two indicators: packaging and labeling. The procedure of verification is simple — experts focus on the text of the normative documentation approved by the Ministry of Health. The remaining indicators are usually checked by the manufacturer at the release control and are issued in the form of a manufacturer’s certificate confirming the quality, which is also submitted to the AIS of Roszdravnadzor

It should also be noted that each distributor must now have a responsible person authorized by a foreign manufacturer confirming compliance with the requirements of the drug, set when registering it.

In case the drug is produced in the territory of the Russian Federation, the responsible person = the authorized person of the manufacturer.

Summarizing the above, according to these requirements for the entry of the drug into civil circulation in Roszdravnadzor it is necessary to provide the following information:

For medicines produced in the Russian Federation:

– Manufacturer’s document confirming quality;

– Confirmation of the Authorized Person of the manufacturer on compliance with the requirements established at its registration;

For medicines imported into the Russian Federation:

– Manufacturer’s document confirming quality;

– Confirmation of the responsible person authorized by the foreign manufacturer of compliance with the requirements established at its registration;

ADDITIONALLY

for three first produced or first imported series (batches) of drug: the protocol of the Federal State Laboratory for Drug Quality Control accredited to established procedure in the field of quality control of the drug, for compliance with the indicators of approved regulatory documentation.

Further, information on the series (batches) of medicines put into circulation is published on the official website of Roszdravnadzor (https://www.roszdravnadzor.ru/services/turnover).

References:

tagged with Drugs

Drugs

medical device approvals | регистрация медицинских изделий

The procedure for entering into civil circulation of medicines for medical use.

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