Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

Article 88 Manufacturing authorisations

1. A manufacturing authorisation shall be required in order to carry out any of the following activities:

(a) to manufacture veterinary medicinal products even if intended only for export;

(b) to engage in any part of the process of manufacturing a veterinary medicinal product or of bringing a veterinary medicinal product to its final state, including engagement in the processing, assembling, packaging and repackaging, labelling and relabelling, storing, sterilising, testing or releasing it for supply as part of that process; or

(c) to import veterinary medicinal products.

2. Notwithstanding paragraph 1 of this Article, Member States may decide that a manufacturing authorisation shall not be required for preparation, dividing up, changes in packaging or presentation of veterinary medicinal products, where those processes are carried out solely for retail directly to the public in accordance with Articles 103 and 104.

3. Where paragraph 2 applies, the package leaflet shall be given with each divided part and the batch number and expiry date shall be clearly indicated.

4. The competent authorities shall record the manufacturing authorisations granted by them in the database on manufacturing and wholesale distribution set up in accordance with Article 91.

5. Manufacturing authorisations shall be valid throughout the Union.