Mutual Recognition of GMP Certificates in EAEU

| By | EAEU, GMP certificate, GMP Inspectorate, Russian Pharma, SID&GP
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In Sochi, within the «Healthy Life. On the Way to Target 80+» Forum, a session under the topic «The system of universal health coverage as a key to achieving the national target» was held.

How much investment is needed to provide drugs to the whole country, what is the share of the state in such investment, what should be a starting point in implementation of the system of universal health coverage, how to define long-term demand of drugs, are there options for reducing prices for drug products along with an increase of the volume of government procurement – these and other relevant topics were discussed by representatives of subject-matter authorities, key drug manufacturers and industry associations on the first day of the Russian Investment Forum. In particular, they talked about mutual recognition of GMP certificates among the EAEU countries.

«If we mean EAEU GMP certificates issued to manufacturers of the member countries, they are recognized by all Union countries. Starting from 01 January, 2021, within the EAEU, only GMP certificates issued according to the EAEU guidelines will be acceptable and acknowledged», reminded the Director of FSI «SID & GP» Mr. Vladislav Shestakov. «Now, in Kazakhstan, a foreign manufacturing company has registered its drug, while its manufacturing site was inspected by the Russian GMP inspectorate. The package of documents submitted by the company to the Ministry of Health of the Republic of Kazakhstan included a GMP certificate issued by the Russian authority, and the documents were deemed acceptable by the Kazakhstan body.»

He also emphasized that currently there are examples of GMP certificate issuance according to the EAEU guidelines: at the end of last year, such a certificate was issued by the regulator of the Republic of Belarus, and this certificate is acknowledged by all EAEU member states.