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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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“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
I am glad that I contacted Pharmacy Consulting Limited (PCL). Jackie Peck helped me in understanding all aspects of community and internet pharmacy. She was helpful in conducting survey, preparing business plan and negotiation with wholesalers etc. She was extremely approachable and provided invaluable advice. She was proactive in helping and was very flexible. I will highly recommend Pharmacy Consulting Limited to all especially young entrepreneurs. It is a money well spent.
“I am new to GDP and the trainer is very patient with my endless questions and has answered them all with rounded practical answers, that I can take back to my workplace and implement it.”Shirley Clifton – Course Rating 10/10
Dawn ran a very informative session about GDP guidance and the role of the Responsible Person. This helped me understand further about my role as the Responsible Person and how to stay 100% compliant according to the guidelines. I also picked up key points on what to look for when looking at potential suppliers and warehouse facilities. All together an excellent session, worth every penny! Pharmaceutical Wholesaler Client
Pharmacy Consulting have provided us with a prompt and professional service, including advice, GDP training and helping us with a robust customised Quality System.During this time they have been committed to fully understanding our company needs and have consistently delivered excellent service.I would highly recommend PCL to any business for peace of mind and sound professional advice. Ben FunnellDirectorUniversal PS
“Very well presented and detailed course. A lot of my questions were answered.”Anonymous – Course Rating 9/10
Well structured and presented course. Puveshni was very knowledgeable in the field and benefited from her experience.Abdirahamn Sheikh – Irmaan
“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
“Covered all questions i had. I left with full knowledge on the topic.”Anonymous – Course Rating 8/10
Good knowledge and practical insight into the requirements.