GovWire

The VMD is responsible for inspecting and authorising veterinary medicines wholesale dealers.

You can only wholesale veterinary medicines if you hold one of the following:

• a manufacturers authorisation
• a wholesale dealers authorisation (WDA)

And the authorisation in question relates to the products 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 that carry out all the activities involved in the wholesale of veterinary medicines; procurement/administration, storage/holding and distribution/supply
• virtual wholesalers, also known as procurement only wholesalers, that buy and sell veterinary medicine but contract out the physical handling of the medicine to another authorised wholesale dealer
• storage and/or distribution wholesalers, that are not involved in taking orders from retailers, but only store and distribute medicines on behalf of another WDA holder to those retailers

Apply for a WDA

Complete the application form for WDA (ODT, 68.2 KB)and send to inspections@vmd.gov.uk

If you need to vary your WDA, complete the variation application form for WDA (ODT, 69.2 KB) and send to inspections@vmd.gov.uk

Your site will be inspected before we grant your authorisation. 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. In exceptional circumstances we may grant you a conditional authorisation to start operating before the inspection has taken place. But again, you may not start to operate until you receive this written confirmation.

Fees

You must pay a fee for the application and for your initial site inspection.

Youll also have ongoing annual and inspectionfees.

The application and annual fees are not refundable or transferable.

• Fees relating to a Wholesale Dealers Authorisation (WDA) in GB

• Fees relating to a Wholesale Dealers authorisation (WDA) in NI

You will qualify for a reduced inspection fee if you only deal in any of the following:

• medicines classified as Authorised Veterinary Medicines-General Sales List (AVM-GSL)
• products marketed under Schedule 6 Exemption from authorisation for medicines for small pet animals
• homeopathic products

Timescales

We aim to process applications within 10 days of receipt.

Your inspection should take place within 90 days of a valid application. We will send you a report within 30 days of the inspection, which sets out any deficiencies noted and what you have to do to address them.

Post authorisation

Once you get your authorisation, youll have regular inspections.

Inspections are risk based depending on your history of compliance with the Good Distribution Practice (GDP) requirements set out in the VMR and the type of veterinary medicines you wholesale. These are summarised in the Authorisation Conditions.

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 authorisation will be revoked if you dont deal in veterinary medicines for 5 years.

Variation to an authorisation

You must notify theVMDbefore making any significant change to your premises, facilities, personnel or operations.

You must complete avariation application form for WDA(ODT,70.1 KB)and send it to inspections@vmd.go.uk 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 theMisuse of Drugs Regulations 2001.

For further information see theControlled drugs: Veterinary medicinespage.

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 use a wholesale dealer who is authorised to wholesale the types of products you wish them to. For example, if you wish them to be involved in any way with the wholesale of special import medicines then they must be authorised to deal in unauthorised products.

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

• only obtain veterinary medicines from authorised manufacturers or wholesale dealers
• only supply veterinary medicines to people who are legally allowed to possess them, for example retailers who are authorised to supply veterinary medicines to end users
• if the supply is to a veterinary surgeon, a pharmacist or a suitably qualified person, it must be to a registered/authorised premises
• only supply veterinary medicines covered by your wholesale dealers authorisation
• only complete the distribution activities listed in your authorisation
• store and transport animal medicines in line with each productsstorage and transport conditions
• 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; those 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
• have appropriate certificates in place and the correct authorisation on your WDA if you are dealing in imported veterinary medicines
• notify the VMD where you have reason to suspect theres a threat to the continued supply of a veterinary medicine
• notify the VMD and the holder of the relevant marketing authorisation if you have been offered a counterfeit veterinary medicine
• keep a record of any returned, recalled or counterfeit veterinary medicine

Site conditions

Your wholesale dealing premises must be all of the following:

• weatherproof
• secure and lockable
• clean
• free from contamination
• designed with designated areas for the receipt of medicines
• capable of storing veterinary medicines under the required