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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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A lot of valuable information to digest. Thank you Anna Drys – Oxford Hospital
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 Funnell Director Universal PS
It was a great pleasure to deal with Pharmacy Consulting Ltd (PCL). I would recommend PCL to everyone especially young entrepreneurs about to embark upon owning their own pharmacy, be it in community pharmacy or Internet pharmacy. I valued the advice and motivation that PCL has given me to pursue my dreams. PCL’s knowledge in pharmacy regulation is vast and up to date and I will definitely use PCL again for my future projects
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
Good knowledge and practical insight into the requirements.
“Really well presented and explained. Have a much better understanding of a very involved subject.” Vicky Stones 10/10
Jackie has proved to be a very knowledgeable and professional recruitment consultant, All communications have been very professional and I would not hesitate to recommend Jackie.
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 think the PCL course dovetails very well with wholesaling as it provides practical course material with a good eye to Quality Management, which is the concern of our company with the MHRA inspection process beginning soon.
We contracted PCL provide us with help and guidance and training, relating to pharmaceutical transportation, we found Jackie and her team to be helpful, knowledgeable and pragmatic in their advice. The training sessions went well and were very useful in helping us understand the subject. We looked long and hard for an industry expert in this field and we certainly found one in PCL. Andrew Fox DX (Group) plc