The Need for a Wholesale Distribution Authorisation for Medicinal Products – WDA
Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA). Anyone in the UK who procures, stores or supplies medicines (including export) must apply to the Medicines and Healthcare Products Regulatory Agency (MHRA) for an Authorisation. There are two types of Authorisation that can be obtained, depending upon the intended use of the medicinal products you wish to distribute, Human or Veterinary. Any company or individual wishing to wholesale deal (defined as selling, supplying or procuring to anyone other than the end-user) medicinal products within the EU must hold a WDA. As a result of the Falsified Medicines Directive (2011/62/eu) that came into force in January 2013, the GDP Guidelines were updated and replaced with the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/1). WDA applications or variations are now made via the MHRA portal.
Why Consider Us for WDA?
Pharmacy Consulting Limited has been offering services to new UK Medicinal Wholesale Distributors since 2006. We offer a ‘one stop shop’ consultancy on how to comply with the current guidelines, apply for an authorisation or a variation to an existing authorisation. Companies wishing to become Wholesale Distributors of Medicines (including pharmacies) need to apply to the MHRA to obtain a Wholesale Distribution Authorisation covering the category, or categories of medicines they wish to distribute. If they also intend to import medicines the appropriate type of licence application must be made relevant to the source country/ies from which such medicines will come. Before making an application, applicants need to have suitable secure premises for the storage of medicines and have developed a set of written Standard Operating Procedures (SOPs) that detail exactly how the various company medicines handling processes and procedures will work. These must comply with Good Distribution Practice (GDP) guidelines for medicines. We can advise on premise requirements and suitability and help customers to prepare a set of suitable Standard Operating Procedures (SOPs). We also send our Senior Consultant along to the MHRA Pre-licensing Inspection to help with questions from the MHRA Inspector. For further information contact us.
Please click on the links below to view full details of each case study.
Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
“Excellent delivery and trainer is very knowledgeable.”Anonymous – Course Rating 10/10
Good knowledge and practical insight into the requirements.
Both Jackie and Sandeep made it really easy to understand the content – they encouraged discussion but also made sure that focus was given to areas specific to the attendees. Overall I enjoyed the course and found it far less overwhelming than I expected.
“A relaxed training environment, and competent instructions, enabled me to gain full knowledge of what i can expect for future MHRA inspections.”David Briggs – Course Rating 9/10
“Very informative course. Well worth attending.”Dave Smith 9/10
I found the information very useful and interesting. I will use the information given in the future for orders I do and also to check all relevant procedures that are needed.
“Very well presented and detailed course. A lot of my questions were answered.”Anonymous – Course Rating 9/10
“Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.”Bill Castle – Course Rating 9/10
Jackie has the experience and ability to support new and existing pharmacy businesses unlike any other.