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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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.
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“Course was very informative and taught/explained very well.”Craig – Course Rating 9/10
“The course was very informative and delivered by Brian in a positive way with lots of examples, to help understand the various topics.”Kalpesh Patel – Course Rating 9/10
“Very informative and John was able to demonstrate a great knowledge of export. Having already completed Pharmacy Consulting’s GDP training, I was able to understand the content and what John was explaining in regard to export”Anonymous – Rating 9/10
As a busy family run logistics business we are really grateful for the expertise of Pharmacy Consulting who came alongside us, pulling out all the stops to meet tight deadlines and helping us to elevate the standard of our Quality System. Thanks to the assistance of Jackie and her team, we are now able to satisfy the exacting standards of larger pharmaceutical wholesalers thereby improving our offerings to our clients and opening up new avenues for our business in the future. Steven DaviesDavies International Transport Limited
Pharmacy consulting helped us to map our warehouse and also to map our new pharmacy fridge they were much cheaper that the other quotes we had and they also trained up the staff on the cold chain SOPs we had jointly written. Thank you Jackie for all your help!
Pharmacy consulting helped us to choose the robot that best suited our requirements and it can be added to at a later date, my regular locum has rescinded his notice as he cannot cope better with the volume of prescriptions we dispense and he gets to sit down to work !
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.Isatec on site training – Bill Castle
‘Really clear and concise and very helpful to point out how much work is still required of us. A great start to the RP journey.’Jon Barden
Great training session provided by Jackie. Could consider providing additional training material (sample forms and documents) for clients apart from the GDP guidelines.
“Very clear, simple to follow. Interactive. Helpful.”Ade – Rating 9/10