Wholesale Dealers' Information & Guidance
The Veterinary Medicines Regulations 2011 came into force on 1 October 2011 and state, amongst other things, that 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 medicinal product 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.
The VMD must be satisfied that the following requirements are being complied with before granting a wholesale dealer's authorisation:
The authorised site must be:
- secure and lockable
- clean; and
- free from contaminants.
If the veterinary medicinal products 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 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 Guideline on Good Distribution Practice for Human Use.
The authorisation may cover more than one site and it lapses if the holder does not trade in veterinary medicinal products for 5 years. An authorisation holder is legally required to notify the VMD before making a material alteration to the premises and facilities used, or in the operations for which they are used, and failure to do so is an offence.
The holder of a wholesale dealer's authorisation must:
- store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product;
- comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use 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.
Further information about the requirements for veterinary only wholesale dealing, including the VMD's inspection criteria and risk based inspection policy, can be found in Veterinary Medicine Guidance Note 8 - Wholesale Dealers' Authorisations for Veterinary Medicines.
Application forms for authorisation as a wholesale dealer under the Veterinary Medicines Regulations 2011 can be downloaded from the Applications Page or obtained from the Inspections Administration Team by telephoning 01932 338328 or 338496 or e-mailing email@example.com.
A fee is payable for an application as a wholesale dealer's authorisation and the inspection of each site from which wholesale dealing will take place. Authorisations will only be granted following a satisfactory inspection of those sites. Authorisation holders are required to pay an annual fee and invoices will be automatically sent to the correspondence address detailed on the original application form. It is therefore important that any change to this address is notified to the VMD immediately.
Please note that the application and annual fees are not refundable or transferable and therefore applicants should contact the VMD if they have any queries regarding the requirement for them to be authorised.
The VMD aims to validate application forms within 10 working days of receipt and carry out an inspection within 90 days of the application form being processed. Where further information or clarification is required from the applicant, the clock will be stopped. Please note that veterinary medicinal products cannot lawfully be acquired, stored, supplied or sold until the site has been inspected, and written confirmation of the wholesale dealerâ€™s authorisation has been received.
The relevant fees are shown below:
|£785||Reduced Fee if:
|£515||If the variation requires scientific or pharmaceutical assessment.|
|£430||If the variation only involves a change of ownership.|
|£830||Reduced Fee if:
|£215||Reduced Fee if:
|Wholesale Dealer's Import Certificate|
|£760||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.