WDA (Wholesale Distribution Authorisation)

WDA (H) and (V)

A WDA (H) is issued by the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK authority responsible for ensuring the quality, safety, and efficacy of human medicines. 

A WDA (V) is issued by the Veterinary Medicines Directorate, which is the UK authority responsible for ensuring the quality, safety, and efficacy of veterinary medicines. 

WDAs will vary as to the specific conditions or restrictions attached to them, such as 

• activities covered – procurement, holding, supply, export, other activities 
• products with additional requirements – medical gases, cold chain, narcotic or psychotropic products, products derived from blood, immunological products, radiopharmaceuticals. 
• legal category of products - prescription only medicine (POM) pharmacy sale (P), general sales list (GSL), controlled drugs (CD) which also require the appropriate Home Office licence issued under the Misuse of Drugs Regulations 2001, Traditional Herbal medicinal Products (THMP), Homeopathic products. 
• source of products - UK, EU or non-UK/EU manufactured. 
• destination of products – UK domestic market, or export to EU or non -EU countries.

Who needs a WDA?

Anyone who procures, stores, or supplies medicines to anyone other than the patient using the medicine needs a WDA (H), and for veterinary products a WDA (V). This includes wholesalers, distributors, importers and exporters.

Online retailers of medicines do not require a wholesale authorisation if they are supplying the end user in quantities of less than 3 months’ supply. Brokers required a broker registration, which permits negotiation on trades, but not the ability to buy, sell or hold.

Requirements prior to applying for a WDA (H) or WDA (V)

Prior to applying for a WDA (H) application, one needs to demonstrate compliance with the Human Medicines Regulations (2012), GDP principles and guidelines which cover the quality system, personnel, premises and equipment, documentation, operations, complaints, recalls, returns, falsified medicines, outsourced activities, self-inspections, transportation, and brokers.

These requirements are addressed in the 10 Chapters of the EU GDP Guidelines (2013/C 343/01).

To apply for a WDA (H), one needs to complete an online application form and submit it to the MHRA, along with the required accompanying documents and fees.

The MHRA will conduct a GDP inspection of the site within 90 days of a validated application before granting or renewing a licence and will also conduct periodic risk-based inspections to monitor ongoing compliance.

The process for applying for a WDA (V) is similar to that for a WDA (H), except that the application and inspection is via the Veterinary Medicines Directorate (VMD).