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Main  >  News  >  Rosselkhoznadzor will change the forms of the inspection report and the conclusion on GMP in accordance with the EAEU norms

Rosselkhoznadzor will change the forms of the inspection report and the conclusion on GMP in accordance with the EAEU norms

Amendments to the order of the Rosselkhoznadzor of 18.10.2016 No. 755 "On approval of the application form for issuing an opinion on the compliance of the manufacturer (foreign manufacturer) of medicinal products for veterinary use with the requirements of the rules of good manufacturing practice, the form of the inspection report based on the results of the inspection of the manufacturer (foreign manufacturer) of medicinal products for veterinary use for compliance with the requirements of the rules of good manufacturing practice and the form of conclusion on the compliance of the manufacturer (foreign manufacturer) of medicinal products for veterinary use with the requirements of the rules of good manufacturing practice ”. The draft document was published on the regulation.gov.ru portal, its discussion will last until October 22, 2020.

The document introduces technical changes to Appendices 2 and 3 (the form of the inspection report and the conclusion on the compliance of the manufacturer (foreign manufacturer) of medicinal products for veterinary use with the requirements of the rules of good manufacturing practice). In the latter, the words of the “Rules of Good Manufacturing Practice, approved by order of the Ministry of Industry and Trade of the Russian Federation No. 916 dated June 14, 2013” ​​are replaced with the words “Rules of Good Manufacturing Practice of the Eurasian Economic Union”.

The inspection report specifies that all identified inconsistencies are assessed in accordance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union, with references to the clauses of the regulatory legal act.

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