The procedure applies to units for import/production/distribution of active substances used in the preparation of veterinary medicinal products for obtaining registration as importer/manufacturer/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 inspection of the unit, and issues the registration within 60 working days from the date of registration of the application.

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

- In case of an incomplete application or documentation, the applicant is informed, within a maximum of 10 working days from receipt of the application, regarding the transmission of the necessary documents to complete the file.

- If the submitted documentation is complete, the unit is inspected by specialized personnel and an inspection report is drawn up, 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 practices for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

For units that meet the conditions provided in the ANSVSA President's Order no. 83/2014 with subsequent amendments and completions, ANSVSA issues the registration of importers/manufacturers/distributors of active substances used in the preparation 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 the inspection report is drawn up.

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

If, after verification by specialized personnel from ANSVSA, the non-fulfillment of the conditions required by current legislation is found, a period for remedying deficiencies of maximum 30 calendar days from the date of drawing up the inspection report is granted.

If, upon verification of the unit, after expiration of the remediation period granted, it is found that the conditions required by current legislation are not fulfilled, the registration file is rejected based on findings made and recorded in the inspection report; the applicant is informed about the decision regarding rejection of the file, within 5 working days from the date of finding non-compliance with legal operating conditions.

The certificate regarding compliance with good manufacturing practice is issued by the specialty department within ANSVSA only in the case of manufacturers of active substances used in the preparation of veterinary medicinal products. This certificate reflects the status of the manufacturing site at that time.