The Need for a Wholesale Distribution Authorisation for Medicinal Products – 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.
Why Consider Us for WDA?
EOMI Consultancy has been helping UK Medicinal Wholesale Distributors to comply with the current guidelines. We provide a comprehensive ‘one stop shop’ consultancy, assisting companies in applying for authorisations or variations to existing authorisations. When obtaining a Wholesale Distribution Authorisation (including pharmacies) to cover the category of medicines they wish to distribute, applicants must ensure that suitable secure premises are available and suitable SOPs complying with Good Distribution Practice (GDP) guidelines have been developed. Our consultancy will advise on premise requirements and help customers to prepare a set of effective SOPs. Additionally, our Senior Consultant is available for assistance during the MHRA Pre-licensing Inspection.
For further details, please Contact Us
GDP Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) stipulate the requirement of the Responsible Person (RP) as well as their duties and obligations expected of them by undertaking this role. The RP must have a high level of knowledge, demonstrate competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines.
Pharmacy Consulting Limited has been offering services to new UK Wholesale Distributors of Medicines since 2006.