The Veterinary Medicines Directorate (VMD) has published new guidance to help applicants for marketing authorisations or variations to understand the requirements for products to be considered suitable for distribution at Authorised Veterinary Medicine – General Sales List (AVM-GSL).
Why this matters
AVM?GSL distributed products do not require any discussion between the purchaser and a veterinarian, pharmacist, or suitably qualified person (SQP). It is therefore essential that clear product information is easily available at the point of sale to help purchasers choose the right product for their animal.
Who this guidance is for
This guidance is for anyone intending to submit an application for a product at a distribution category of AVM?GSL. This includes applications for new products and variations to lower the distribution category, for example moving from NFA?VPS to AVM?GSL.
What the guidance covers
The guidance explains:
- what information should be included on the outer package
- user?friendly language, structure and phrases required on the packaging or in the product leaflet if separate
- the typical maximum pack size considered suitable for AVM-GSL distribution
Applicants are reminded that products authorised under one marketing authorisation number can have only a single distribution category and therefore all pack sizes included in this authorisation should comply with the guidance.
About distribution categories
Distribution categories for veterinary medicines determine their supply route based on risk, with requirements for veterinary input decreasing from prescription-only to general sales.
There are four main legal distribution categories for authorised veterinary medicines in the UK:
- Prescription Only Medicine – Veterinarian (POM-V)
- Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS)
- Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS)
- Authorised Veterinary Medicine – General Sales List (AVM-GSL)
Please visit our guidance for more information on how the supply of veterinary medicines are restricted under each of these distribution categories.
Find out more
Read the full guidance: Apply to change a veterinary Marketing Authorisation or Homeopathic Remedy - GOV.UK.
For queries about the guidance, contact: postmaster@vmd.gov.uk.