Authorization of wholesale distribution of veterinary medicinal products (VMP), good distribution practice (GDP)
Pursuant to Section 77(1)(g) of Act No 378/2007 on medicinal products and amending certain related acts, as amended, the ÚSKVBL publishes guidelines, procedures and information.
These guidelines, procedures and information are intended for existing VMP distributors and new applicants for a wholesale distribution authorisation for VMP and provide further information on the procedures for the approval of a distribution activity, including the approval of changes and extensions to that activity. Furthermore, they describe in more detail some legal regulations and requirements in the area of SDP for VMP.
Instructions for reporting the sales of VMPs can be found here.
Main legislation:
Regulation (EU) 2019/6 on veterinary medicinal products
Implementing Regulation (EU) 2021/1248 on measures for good distribution practice for 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
Decree No. 229/2008 Coll., on the production and distribution of pharmaceuticals, as amended
Documents which are available only in Czech are at this link.