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Main  >  News  >  The regulations for issuing GMP certificates of the EAEU were approved

The regulations for issuing GMP certificates of the EAEU were approved

On September 15, 2020, the Ministry of Justice registered (No. 59855) the order of the Ministry of Industry and Trade of the Russian Federation dated September 4, 2020 No. 2945, which approves the administrative regulations of the Ministry of Industry and Trade for the provision of public services for the issuance of certificates of compliance of drug manufacturers with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU). The document was published on the portal publication.pravo.gov.ru.

THIS ORDER COMES INTO FORCE FROM THE DATE OF THE ENTRY INTO FORCE OF THE ACT OF THE GOVERNMENT OF THE RUSSIAN FEDERATION ON CERTAIN MATTERS RELATED TO THE PERFORMANCE OF PHARMACEUTICAL INSPECTIONS.

Control over the execution of the order is entrusted to the First Deputy Minister of Industry and Trade of the Russian Federation S.A. Tsyba.

The administrative regulations establish the terms and sequence of administrative procedures (actions) carried out by the Ministry of Industry and Trade, the procedure for interaction between its structural divisions, their officials, with government bodies when providing a public servant, including with the State Institute of Medicines and Good Practices ( GILS and NP).

Applicants for receiving government services are both drug manufacturers (legal entities) manufacturing in Russia, and foreign manufacturers, or their authorized representatives.

The provision of public services is carried out directly by the Department of Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation.

The term for the provision of public services is calculated from the day the Ministry receives a completed application, a full package of documents. The Ministry decides to issue (refuse) the certificate within a period not exceeding 90 calendar days after the last day of the last inspection. The deadline for eliminating violations in the submitted documents is 20 working days from the date of receipt of the corresponding notification.

The document says that the government service is provided free of charge.

 

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