The preliminary draft applies to veterinary medicinal products as referred to in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing the Directive 2001/82/EC.

Preliminary draft law on veterinary medicinal products

This preliminary draft law on veterinary medicinal products provides for the completion and adoption of the implementing provisions of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

In the light of the present notification, this preliminary draft specifically provides for:
- rules on the procedure for obtaining a marketing authorisation and exemption schemes;
- rules on labelling and package leaflets;
- rules on pharmacovigilance;
- rules on manufacture and preparation;
- rules on wholesale and retail trade;