Wholesale Distribution Authorisation – WDA

Anyone in the UK who acquires, stores or supplies medicinal products (including exports) must apply for an authorisation from the MHRA. Depending on what they intend to distribute – Human or Veterinary – two kinds of authorisation are available. Companies or individuals that plan to wholesale deal medicinal products across the EU must obtain a WDA.

Wholesale dealing or distribution

2.1 Medicinal products which are medicines for human use are subject to the provisions of the Human Medicines Regulations 2012. This includes unlicensed medicinal products commonly referred to as “specials”.

2.2 It is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the UK through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions. The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products.

2.3 The Human Medicines Regulations 2012 defines wholesale distribution of medicinal products as: “selling or supplying it, or procuring or holding it or exporting it for the purposes of sale or supply to a person who receives it for a purpose. Those purposes are selling or supplying the product or administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.”

2.4 The holder of a Wholesale Dealer’s Licence must fulfil certain obligations and conditions

Persons operating from the UK require a Wholesale Dealer’s Licence (WDA(H)) if, in the course of their business, they are engaged in:

• importing a medicinal product from an approved country for import into Great Britain for the purposes of distributing a medicinal product by way of wholesale dealing, or possessing a medicinal product for the purpose of such distribution;
• procuring, holding, supplying or selling medicinal products for human use sourced in the UK or an approved country for import to anyone other than members of the public or exporting it for the purposes of sale or supply;
• supplying a listed Northern Ireland MHRA Authorised Route (NIMAR) medicinal product from Great Britain to Northern Ireland.