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Marketing Authorization Certificate: New Form

The Ministry of Healthcare of the Russian Federation has published Decree No 320n “On approval of the form of marketing authorization certificate of a medicinal drug” on 26.05.2016.

The document has been registered in the Ministry of Justice on August 4, 2016. However, it does not mean that holders of marketing authorizations of the old version must renew them as soon as possible. The documents issued are effective till the end of the valid term, while the drugs that currently undergo the registration procedure will receive certificates of new type, prepared on the blanks with level B protection, according to requirements of the Eurasia economic union.

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