Publication
Information for Wholesale Distribution Authorisation Holders
From Department of Agriculture, Food and the Marine
Published on
Last updated on
Wholesale distribution means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products (VMPs) whether for profit or not, apart from retail supply of veterinary medicinal products to the public.
The wholesale distribution of VMPs is subject to the holding of a wholesale distribution authorisation (WDA). All WDAs will be valid throughout the Union.
The European Medicines Agency (EMA) are developing a WDA & Manufacturing Co database - Eudragmdp . All WDAs will appear on this database.
All WDAs must comply with Good Distribution Practice (GDP), details can be found in EU 2021/1248 . The aim of GDP is to assist WDAs in conducting their activities and to guarantee that VMPs are appropriately procured, stored, transported and handled as well as to ensure control of the distribution chain and consequently maintain the quality and the integrity of VMPs while preventing falsified medicines from entering the legal supply chain. As part of GDP all WDAs must have in place a Responsible Person (RP). The RP shall have appropriate competence and experience as well as knowledge of, and training in, compliance with GDP for VMPs.
