Wholesale Dealers' Information & Guidance
Only the holder of a marketing authorisation, the holder of a manufacturing authorisation or the holder of a wholesale dealer's authorisation granted by the Secretary of State may supply a veterinary medicine by wholesale, or be in possession of it for that purpose.
The VMD carries out the inspection and authorisation of veterinary-only wholesale dealers on behalf of the Secretary of State. Where medicines are being wholesaled for both human and veterinary use, the inspection and authorisation is carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
Requirements for the site
Before we grant a wholesale dealer's authorisation, we must be satisfied that the site is:
- secure and lockable
- clean and
- free from contaminants
If the veterinary medicines covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.
The authorisation holder must also have the services of technically qualified staff and an effective emergency recall plan.
A wholesale dealer's authorisation will specify:
- the types of veterinary medicinal products and pharmaceutical forms that may be dealt in
- the place (site) where they are to be stored
- the name and address of the person or company holding the authorisation;
- the address of the premises to which it relates, and
- the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice for Human Use
Duties once you are authorised
Once the site is authorised, you must:
- store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product
- comply with the Rules and Guidance for Pharmaceutical Distributors 2007 (ISBN 978-0-85369-758-9) as if the veterinary medicinal products were authorised human medicinal products
- carry out a detailed stock audit at least once a year and
- supply information and samples to the Secretary of State on demand.
Your authorisation may cover more than one site. You must notify the VMD before making a material alteration to the premises and facilities used, or in the operations for which they are used. Failure to do so is an offence.
Your wholesale dealer's authorisation will lapse if you do not trade in veterinary medicines for 5 years.
Further information on wholesaling
You can find further information about the requirements for veterinary-only wholesale dealing, including the VMD's inspection criteria and risk-based inspection policy in Veterinary Medicine Guidance Note 8 - Wholesale Dealers' Authorisations for Veterinary Medicines.
Making an application
You can download application forms for authorisation as a wholesale dealer from the Applications Page. You can also contact the Inspections Administration Team to ask for a form by telephoning 01932 338328 or 338496 or e-mailing email@example.com.
There is a fee for an application for a wholesale dealer's authorisation and for the initial inspection of each site from which wholesale dealing takes place. There are ongoing annual and inspection fees. The fees are set out below under 'Fees'.
We will automatically send invoices for fees to the correspondence address you gave us on your original application form. Therefore please ensure that you tell us of any change to this address immediately.
The application and annual fees are not refundable or transferable. You may wish to contact the Inspections Administration Team before applying if you have any queries regarding authorisation.
Timescales for applications
We aim to process application forms within 10 working days of receiving them. We will then carry out an inspection within a further 90 days.
If the application form is not complete, we may need to contact you, which could delay the process.
You cannot start wholesaling activities before you have written confirmation from us that the authorisation has been granted.
The fees are:
|£785||Reduced Fee if:
|£515||If the variation requires scientific or pharmaceutical assessment.|
|£430||If the variation only involves a change of ownership.|
|£1442||Reduced Fee if:
|£830||Lower Fee if:
|£315||Reduced Fee if:
|£215||Lower Fee if:
|Wholesale Dealer's Import Certificate|
|£1320||The fee payable by the holder of a wholesale dealer's authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4.
The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.