The procedure applies to manufacturing/import units of veterinary medicinal products, for obtaining the certificate regarding 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 documents submitted for the purpose of carrying out the inspection:

a) if the documentation presented 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 provided; in this case, the 90-day term stipulated in the Veterinary Sanitary Norm regarding the conditions for organizing and operating veterinary pharmaceutical units, as well as the procedure for veterinary sanitary registration/authorization of units and activities in the veterinary pharmaceutical field, approved by the Order of the President of ANSVSA 83/2014, with subsequent amendments and additions, begins to run from the date when the applicant has completed the documentation.

- The manufacturing authorization for veterinary medicinal products, for requesting 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 Veterinary Sanitary Norm regarding the establishment of principles and guidelines related to good manufacturing practice for veterinary medicinal products, approved by the 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 within ANSVSA, which is sent to the requesting 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, in accordance with the provisions of the Order of the President of ANSVSA no. 83/2014, with subsequent amendments and additions; 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 the applicant registers the complete documentation, ANSVSA issues the Certificate regarding compliance with good manufacturing practice and the manufacturing authorization;

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

- The certificate regarding 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 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 conditionally upon fulfillment of certain imposed obligations;

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

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

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