The procedure applies to manufacturing/import units of veterinary medicinal products, for obtaining the certificate of compliance with good manufacturing practice and the manufacturing authorization for veterinary medicinal products from the National Sanitary Veterinary and Food Safety Authority (ANSVSA).

Within 30 days from the date of registration of the application, ANSVSA responds to the applicant regarding the submitted documents for the purpose of conducting the inspection:

a) if the submitted documentation is complete, the applicant is notified regarding the acceptance of their inspection request and the amount of the fee to be paid;

b) if the documentation is not complete, the applicant is notified regarding the information that needs to be submitted; in this case, the 90-day period provided in the Sanitary Veterinary Regulation on the conditions for the organization and operation of veterinary pharmaceutical units, as well as the procedure for veterinary sanitary registration/authorization of units and activities in the veterinary pharmaceutical field, approved by Order of the President of ANSVSA 83/2014, with subsequent amendments and completions, starts from the date the applicant has completed the documentation.

- The manufacturing authorization for veterinary medicinal products, for applicant units, has as a mandatory requirement the certification of the unit regarding compliance with good manufacturing practice; the inspection consists of verifying compliance with the provisions of the Sanitary Veterinary Regulation regarding the establishment of principles and guidelines relating to good manufacturing practice for veterinary medicinal products, approved by Order of the President of ANSVSA no. 86/2020, and the Good Manufacturing Practice Guide for veterinary medicinal products, published on the website of the National Sanitary Veterinary and Food Safety Authority.

- The inspection is carried out according to the evaluation plan drawn up by designated specialists from ANSVSA, which is sent to the applicant unit at least 3 days before the inspection date;
- The unit inspection is finalized by drawing up an inspection report in the format established by the European Commission through the document Compilation of Union Procedures on Inspections and Exchange of Information, according to the provisions of Order of the President of ANSVSA no. 83/2014, with subsequent amendments and completions; the report is sent to the applicant within 15 calendar days from the date it is drawn up;

- In the case of a favorable evaluation report, within a maximum of 90 days from the date of registration of the complete documentation by the applicant, ANSVSA issues the Certificate of Compliance with Good Manufacturing Practice and the Manufacturing Authorization;

- In the case of an unfavorable evaluation report, after correcting the identified deficiencies, the unit may request a new inspection;

- The certificate of compliance with good manufacturing practice is issued in the community format published on the website of the National Sanitary Veterinary and Food Safety Authority and reflects the status of the manufacturing site at the date of the inspection; this certificate is valid for 3 years from the date of the unit's inspection;

- The manufacturing authorization is issued in the format established by the European Commission through the document Compilation of Union Procedures on Inspections and Exchange of Information.

- In accordance with the provisions of Regulation (EU) 2019/6, the manufacturing authorization may be issued subject to fulfillment of certain imposed obligations;

- The validity of the manufacturing authorization is conditioned by the validity of the certificate of compliance with good manufacturing practice;

- The manufacturing authorization is granted only for the spaces, veterinary medicinal products and pharmaceutical forms specified in the application and is valid for 3 years from the date of the last inspection of the unit for good manufacturing practice.

- At least 3 months before the expiry of the certificate of compliance with good manufacturing practice, its holder must submit to the specialized department within ANSVSA the documents provided for in art. 65, in order to carry out the inspection according to the provisions of Regulation (EU) 2019/6.