The procedure applies to units of import/production/distribution of active substances used in the manufacture of veterinary medicinal products for obtaining the registration of the importer/producer/distributor of active substances from the National Sanitary Veterinary and Food Safety Authority (ANSVSA).

ANSVSA registers the application of the legal entity, checks the file, carries out the unit inspection, and issues the registration, within 60 working days from the date of registration of the application.

The term can be extended only once, by the competent sanitary veterinary and food safety authority, for a period of maximum 15 working days, in case the completion of the submitted documentation is requested.

- In the case of an incomplete application or documentation, the applicant is informed, within no more than 10 working days from the receipt of the application, regarding the submission of the necessary documents for the completion of the file.

- In case the submitted documentation is complete, the unit is inspected by specialized staff and an inspection report is drafted, in the format established by the European Commission through the document Compilation of Union Procedures on Inspections and Exchange of Information.

The activity of distribution of active substances is carried out in compliance with the provisions of Regulation (EU) 2019/6 and Commission Implementing Regulation (EU) 2021/1.280 regarding measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and Council.

For units that meet the conditions provided in Order of the ANSVSA president no. 83/2014 with subsequent amendments and completions, ANSVSA issues the registration of importers/producers/distributors of active substances used in the manufacture of veterinary medicinal products, in the format established by the European Commission through the document Compilation of Union Procedures on Inspections and Exchange of Information, within 10 working days from the date of drafting the inspection report.

The inspection of import/production/distribution units of active substances used in the manufacture of veterinary medicinal products is carried out for each work point.

If, following verification by specialized personnel within ANSVSA, it is found that the conditions provided by the legislation in force are not met, a deadline for remedying the deficiencies of maximum 30 calendar days from the date of drafting the inspection report is granted.

If, after verification of the unit, after the expiration of the remedy period granted, the non-fulfilment of the conditions provided by the legislation in force is found, the registration file is rejected based on the findings made and recorded in the inspection report; the applicant is informed of the decision regarding the rejection of the file, within 5 working days from the date of finding the failure to meet the legal operating conditions.

The certificate of compliance with good manufacturing practice is issued by the specialized directorate within ANSVSA only for manufacturers of active substances used in the production of veterinary medicinal products. This certificate reflects the status of the manufacturing site at that date.