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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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“Kim was able to give good examples, in order to understand. She would also ask us specific questions and if we didn’t understand she would word it in a different way which really helped me to understand GDP.”Suzi – Course Rating 8/10
“Very informative course. Well worth attending.”Dave Smith 9/10
“Excellent refresher, very informative. Thank you.”Addy Mohammed – Course Rating 10/10
Jackie from PCL has the experience and ability to support new and existing pharmacy businesses unlike any other.
Again, I stress how much I appreciate all your help, both today and through the whole journey of us striving to obtain our WDA(H).
“Excellent, personable and very informative”Anonymous – Course Rating 10/10
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
“I found this course much more interesting and accessible than i thought it would be. Nicely paced with enough information to be challenging and thought provoking but not overwhelming. A few of the initials could do with explaining though.”Jennifer Kirby – Course Rating 9/10
“Good Training day, thank you.”Course Rating 10/10
Very good informative trainer, excellent delivery on a rather dull topic. Kept our interest well which helped with learning. Jackie answered every questions I had. Thank you