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The rules for the provision of public services for veterinary producers on the GMP certification

The Rosselkhoznadzor has submitted a draft Administrative Regulation on the provision of public services to issue an opinion on the compliance of the manufacturer of medicines for veterinary use with the requirements of the rules of good manufacturing practice (GMP). The draft document was published by regulation.gov.ru, its discussion until April 10, 2020.

The order must enter into force on the date of recognition of the order of the Ministry of Agriculture of Russia dated March 1, 2017 No. 82 “On approval of the Administrative Regulations of the Federal Service for Veterinary and Phytosanitary Supervision for the provision of public services on issuing an opinion on the conformity of the manufacturer of medicines for veterinary use with the requirements of the rules Good Manufacturing Practices ”(registered by the Ministry of Justice on May 24, 2017, No. 46807).

According to the document, the applicants are manufacturers of medicines for veterinary use, the production of which is carried out in the Russian Federation, or manufacturers of medicines for veterinary use, the production of which is carried out outside the Russian Federation, or their authorized representatives.

The provision of public services for the issuance of an approval / refusal to issue an opinion is carried out within a period not exceeding 219 working days from the date of receipt by the Rosselkhoznadzor of an application for the issuance of an opinion and documents.

The provision of public services for the issuance of a new opinion with the expiration date of the previously issued opinion when the name and (or) address of the location of the manufacturer or foreign manufacturer, the list of drugs manufactured at the same production site and in the same conditions, change during the validity period of the issued opinion, specified in the conclusion, is carried out in a period not exceeding forty 3 working days from the date of receipt in the Rosselkhoznadzor from the manufacturer or foreign production Itel application for issuing opinions and documents.

Elimination of the revealed violations by the applicant in case of incompleteness and (or) inaccuracy of the information contained in the application and (or) in the submitted documents - 20 working days from the date of documentary confirmation of receipt by the applicant of a notification about the need to eliminate the detected violations.

Issuance (direction) to the applicant of a conclusion or direction to the applicant of a notice of refusal to issue a conclusion - 3 business days from the date of signing the conclusion or notification of refusal to issue a conclusion.

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