Certificate of Good Manufacturing Practice for veterinary medicinal products

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• 1
  Step 1. Submission of the request

  The applicant (legal entity) submits the application at the ANSA counter at the address: Chisinau municipality, M. Kogălniceanu str. 63, by post, or by email: info@ansa.gov.md.

  Only a holder of the sanitary veterinary authorization with the profile manufacturing veterinary medicinal products can apply for the issuance of the Certificate of Good Manufacturing Practice (GMP) of veterinary medicinal products.

  
  

• 2
  Step 2. Payment of the service

  Payment for the service can be made through the government electronic payment service MPay.

• 3
  Step 3. Processing and Review

  After receiving the confirmation of payment of the service, the National Agency for Food Safety examines the application and accompanying documents and verifies their authenticity. In the case of finding the lack of necessary documents/information expressly provided by the legislation, the Agency suspends the term for examining the application and informs the applicant with the specification and description of the basis for the suspension, the term and remedial actions to initiate the examination of the application.

  The Agency starts an inspection, verifying whether the Good Manufacturing Practice Rules are respected in the production process. It is also checked (within up to 90 calendar days) whether the manufacturing processes used in the production of veterinary medicinal products are fully validated and whether the conformity and uniformity of the batches is ensured. The representatives of the Agency prepare an "assessment report" in which it is recorded whether the applicant complies with the Good Manufacturing Practice Rules and inform the applicant of its contents.

  
  

• 4
  Step 4. Release/deferral/refusal of release

  If the present documents meet the requirements and the "evaluation report" states that the Good Manufacturing Practice Rules are respected, the Agency completes the act, and the completed certificate is issued. The certificate is received at the Agency counter.