In order to legally run a business that deals with the wholesale of animal medicines (veterinary medicinal products) you must obtain a veterinary medicines Wholesale Distribution Authorisation (WDA(V)) from the Veterinary Medicines Directorate (VMD).
You must obtain a WDA(V) to sell or supply medicines to anyone other than the end user. This includes:
- Wholesalers who carry out all the activities involved in the wholesale of animal medicines (procurement, storage and distribution)
- ‘Virtual wholesalers’, also known as procurement only wholesalers, that is buying and selling an animal medicine but contracting out the physical handling of the medicine to another authorised wholesale dealer
- Storage and/or distribution, that is not involved in taking orders from retailers, but will store and distribute medicines on behalf of another WDA holder to those retailers
As like the MHRA, the VMD will inspect your site within 90 days of your application being validated (note: the term used here is validated, not submitted however the VMD state that they aim to process applications within 10 days of receipt).
Further information on this process and requirements can be found here:
https://www.gov.uk/guidance/apply-for-a-veterinary-medicine-wholesale-dealers-authorisation-wda
If you only hold a WDA(V) the licence and inspection process will be handled exclusively by the VMD. However, if you plan to also supply Human medicines to veterinary practices to be prescribed under the cascade, you will also be required to obtain a WDA(H) licence from the MHRA. The MHRA will then inspect both licenses on behalf of the VMD.
The person nominated on a WDA(V) licence whom is responsible for ensuring compliance with Good Distribution Practice is not a Responsible Person (as is on a WDA(H) licence) but is known as a Wholesale Dealer Qualified Person (WQP), with their responsibilities being very similar to an RP nominated on a WDA(H) licence.
Pharmacy Consulting Ltd have the expertise and knowledge required to support new WDA(V) applications and provide contract WQP support so please contact us for further details at: [email protected]