For further guidance on the notification of the activities of importers, manufacturers and distributors of active substances (API) for veterinary medicinal products (VMP) and on the notification of changes.
Main legislation:
Regulation (EU) 2019/6 on veterinary medicinal products
Implementing Regulation (EU) 2021/1280 on good distribution practice measures for active substances used as starting materials in veterinary medicinal products
Act No 378/2007 on pharmaceuticals, as amended
Documents which are available only in Czech are at this link.