Russia to Recognize GMP Certificates Issued in EAEU
The EEC Council’s Decision No.101 of September 27, 2023 provides for mutual recognition of EAEU GMP certificates, granting the competent national authorities the right to certify a local manufacturer not later than March 13, 2024. As of now, five companies from Belarus can exercise this right.
The EEC Council’s Decision “On Amending EEC Council’s Decision No. 1 of January 21, 2022” took effect on October 20, 2023. It was designed to remove the inconsistency between Russian national law and the Treaty of the Eurasian Economic Union, as the requirement to obtain Russian GMP certificates for VMPs manufacturers companies to access the market was recognized by the Council as “an obstacle or a barrier” to trade.
In Russia, the regulation on market release of VMPs came into effect on September 1, 2023. It requires laboratory tests to be carried out within the country’s borders and bans imports of drugs whose manufacturers have yet to obtain GMP certificates from Russia’s authorities. Since 2017, foreign companies have made almost 200 attempts to go through the GMP audit process, but mostly to no avail. As of now, only 36 production sites abroad have passed the Russian GMP audits successfully.
AVPHARM estimated that the changes in the EAEU regulatory framework would enable five companies from Belarus to supply more than 400 veterinary medicinal products to Russia. With valid Belarussian EAEU GMP certificates at their disposal, such manufacturers are permitted to release their VMPs to the Russian market. It is noteworthy that Belarussian veterinary medicinal products are familiar to Russian customers, as they could circulate in the country freely and without local market authorizations well before the September 1 regulation came into force.
The draft decision was developed by the EEC back in the spring of 2023, with the version of the document open to public discussion allowing more scope for mutual recognition. For instance, it would oblige the member states to mutually recognize EAEU GMP certificates, including those issued in third countries. As Belarus is currently the only country in the EAEU beyond Russia with the functional GMP inspectorate, the final draft of the decision favors primarily local manufacturers, but fails to address the needs of international manufacturers who have yet to be GMP certified by Russia’s competent authorities.
It is worth mentioning that AVPHARM is being bombarded with questions about veterinary medicinal products, above all immunobiologicals, produced by non-CIS countries. These days most international animal health companies are no longer allowed to access the Russian market, because they have failed to receive valid Russian EAEU GMP certificates. Given the fact that 36 manufacturing sites abroad have so far passed GMP inspections, it is now possible to expect the market release of only 180 medicinal products. This is in stark contrast to the year 2022 when more than 740 foreign veterinary medicines were imported to Russia from non-CIS countries. The actual number of imported new products differs from that of drugs allowed for market release. For instance, the Russian veterinary market has received just six foreign vaccines in recent three months.
EEC Board meeting on November 21, 2023, photo by EEC
