Licences for Medicines Wholesale – Do you know what is required by you as a pharmaceutical wholesaler to fulfil legal requirements when working with medicines? Read on to learn the basics of why you need a WDA and where to find further information to accelerate your learning.
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What does WDA stand for?
Wholesale Distribution Authorisation – (H) Human / (V) Veterinary
It may also be referred to as a ‘Wholesale Licence’ or ‘Wholesale Dealers Licence’.
Why do I need one?
If you undertake any wholesale activity in relation to medicinal products, as defined within the legislation, you need a WDA. This may be for procuring, storing, supplying and/or exporting medicines. A wholesale licence may also allow you to undertake certain import activities.
What does a WDA allow me to do?
It depends! You must ensure that all activities you undertake and all relevant products you handle, are listed on your licence. You must not undertake any activities or handle any products that are not covered by your current licence.
Once a WDA is granted, you can make changes including adding or removing products and activities by submitting a request for a variation.
Which organisations regulate and monitor the wholesale and retail supply of medicines?
- Human – MHRA, General Pharmaceutical Council and in certain circumstances the Department of Health and Social Care
- Veterinary – Veterinary Medicines Directorate
- Note: MHRA issue “V” vet and “H” human WDAs, if jointly applied for
What is a wholesale transaction?
In this context, it is the process of supplying medicinal products from one individual or business to another, unless that individual is the consumer in which case it is a retail transaction. Again in this context, the supply may or may not involve a financial transaction.
What countries can I operate in with my WDA?
A WDA issued by the MHRA covers businesses operating in the UK. Depending on what activity you have specified on your WDA it may allow you to trade with companies in the EU and other parts of the world.
Which Pharmacies need a WDA?
Pharmacies providing stock medicines to another legal entity with or without a formal contract in place. This includes those:
- Pharmacies in NHS Trusts;
- Registered Community Pharmacies
- Pharmacies located in other settings, such as community hospitals and prisons
How long will it take to process my licence?
From the date of application you’re looking at, at least 90 working days for a new licence to be granted and 30 working days for a variation (depending on the type of variation this may entail a site inspection, where an inspection is needed the variation may take longer).
What is the cost?
Full application for a WDA is typically £3739 (£1803 application fee plus £1354 assessment fee).
The cost of variations depends on the type of variations and are listed in this link:
Current MHRA fees – GOV.UK (www.gov.uk)
- Note: These are only the MHRA fees, there may be considerable set up fees as well.
Where can I learn more?
Join our monthly PCL online forum on 8th March to learn more about the licences, legalities, requirements, how to get one and ask our experts any of your own questions. If you would like to see a full list of our future topics visit our RP Forum page.
To book your place visit our bookings page.
Price £25.00
This information is provided by PCL using data directly taken from the department of health and gov.uk websites. For more information visit: