GovWire

The Veterinary Medicines Directorate (VMD) is responsible for inspecting and authorising veterinary wholesale dealers.

You can only be involved in the wholesale of animal medicines if you have one of the following:

• a marketing authorisation

• a manufacturers authorisation

• a wholesale dealers authorisation (WDA)

And the authorisation in question relates to the product(s) youre wholesaling.

When you need a WDA

You must obtain a WDA 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

You do not need a wholesale dealer licence if youre a broker. A broker is someone who has arranged for a retailer to buy animal medicines directly from a wholesale dealer at a reduced rate.

Apply for a WDA

Complete the application form for WDA (ODT, 66.6 KB) and send to the VMD.

If you need to apply for a variation to your WDA, submit the variation application form for WDA (ODT, 70.1 KB)

Email:inspections@vmd.gov.uk

Your site will be inspected before the VMD grant your application. This inspection should take place within 90 days of your application being validated.

You cant start wholesale dealing before you get confirmation in writing that your authorisation has been granted.

Fees

You need to pay a fee for the application for your WDA and for your initial site inspection.

Youll also have ongoing annual and inspection fees.

The application and annual fees are not refundable or transferable.

You should qualify for a fee reduction if your annual turnover is less than 35,000 or you only deal in any of the following:

• medicines classified as Authorised Veterinary Medicines-General Sales List (AVM-GSL)

• products covered by the exemption for small pet animals

• homeopathic products

Timescales

We aim to process applications within 10 days of receipt.

Post authorisation

Once you get your authorisation, youll have regular inspections.

Inspections are risk based depending on your history of compliance with GDP requirements, your compliance with the Veterinary Medicines Regulations (VMR) and the type of veterinary medicines you wholesale.

You must make your site available for inspection and provide any information or samples requested.

Validity of authorisation

Your authorisation is valid indefinitely subject to satisfactory inspections. However, your WDA will be revoked if you dont deal in veterinary medicines for 5 years.

Variation to an authorisation

You must notify the VMD before making any significant change to your premises, facilities or operations.

You must complete a variation application form for WDA (ODT, 70.1 KB) and send it to the VMDs inspection administration team to change an existing authorisation.

Authorisation conditions

You must have an appropriate Home Office licence if you wish to wholesale controlled drugs.

You must have a signed requisition form (signed in ink) to sell any controlled drugs listed in schedule 2 or 3 of the Misuse of Drugs Regulations 2001.

For further information see the Controlled drugs: Veterinary medicines page.

You must have a valid and suitable contract in place if you want another wholesale dealer to be responsible for the storage and distribution of your medicines. The contract must state where the division of responsibilities lies.

You must also do all of the following to meet the conditions of your authorisation:

• get animal medicines only from authorised marketing authorisation holders, manufacturers or wholesale dealers

• supply animal medicines only to people who are legally allowed to have them, for example retailers who are authorised to supply veterinary medicines to end users

• only supply animal medicines covered by your wholesale dealers authorisation

• list all your distribution activities in your authorisation

• store animal medicines in line with storage and transport conditions

• make sure you have proper stock rotation and carry out a detailed stock audit at least once a year

• have an emergency recall plan (a system in place that if a recall of the product is required then the company is readily able to identify and contact all their customers)

• have technically competent staff (who are trained in all of the company procedures and understand the principles of GDP)

• set up and maintain a quality system (a system detailing your quality and distribution procedures)

Site conditions

Your wholesale dealing premises must be all of the following:

• weatherproof

• secure and lockable

• clean

• free from contamination

• capable of storing animal medicines under the required storage conditions

WDA Qualified Person

You must choose someone to be your wholesale dealer qualified person, (WQP), and register their details with the VMD.

This person will be responsible for making sure youre meeting the conditions of your authorisation. They should regularly check all storage areas, samples of records, the quality system and keep records of the checks they do.

This person doesnt have to be a pharmacist, but they should know about the conditions of your authorisation and the medicines you distribute.

If theyre not a pharmacist, they should have at least a years experience in either of the following:

• handling, storing and distributing medicines

• supplying or obtaining medicines

They should also have at least a years experience in managing the wholesale distribution of medicines on a similar scale.

You dont have to employ this person, but they must

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