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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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“Well structured and presented course. Puveshni was very knowledgeable in the field and benefited her experience.”Abdirahman – Course Rating 10/10
“Covered all questions i had. I left with full knowledge on the topic.”Anonymous – Course Rating 8/10
Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
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 FoxDX (Group) plc
A very informative overview of GDP and the role of the RP. Great to be able to discuss GDP issues with Brian and with others on the course.
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!
I found the course on Training to be a responsible person to be a very well thought and structured course which gave me the roles and resources to come away understanding the training given. It was very informative, topical and saved me time and money trying to wade through a minefield of work to become a responsible person – Jackie is highly qualified and delivers an excellent course, would highly recommend to anyone looking at wholesaling.
“A lot of valuable information to digest! Thank you.”Anna Drys – Course rating 9/10
/”Very informative and put in an easy to understand way. The course was explained so I can say i left feeling that I understood my role going forward. Thank you.Marie Wakeham – Course Rating 9/10
‘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