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«The Company of Decade - the Russian pharmaceutical products manufacturer»

Manufacturing Licenses

Pursuant to the law 'On the Circulation of Pharmaceuticals in the Russian Federation', the Government of the Russian Federation Decree 'On Amending Several Acts of the Government of the Russian Federation in Connection with the Adopted Federal Law «On the Circulation of Pharmaceuticals», the authority to license the production of pharmaceuticals and keeping the registry of the issued licenses has been transferred to the Ministry of Industry and Trade of the Russian Federation.

According to the new Provisions for Licensing the Production of Pharmaceuticals, in addition to the already existing requirements and conditions, to receive a license the producer should have, among its employees, an authorised person who confirms compliance of the pharmaceuticals to the requirements established during their registration and guarantees that the pharmaceutical preparations have been produced in accordance with the Rules of GMP. Apart from that, the licensee should be in conformity with the requirement regarding state registration of maximum selling prices for pharmaceuticals and regarding the rules of disposal of poor-quality, fake and counterfeit pharmaceuticals.

At the present moment, the enterprises of Pharmstandard have all the necessary licenses for production of various forms of sterile and non-sterile pharmaceutical preparations.

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