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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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.
Please click on the links below to view full details of each case study.
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
“Very informative course. Well worth attending.” Dave Smith 9/10
Good knowledge and practical insight into the requirements.
“Very informative training day.” “Highly recommended”
Informative & Interactive. Thank you.
Very informative, Jackie created a relaxed atmosphere which was conducive to active participation of the whole group. Jackie also provided a summary of the recent MHRA convention which was very beneficial.
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.
Great training session provided by Jackie. Could consider providing additional training material (sample forms and documents) for clients apart from the GDP guidelines.
Pharmacy Consulting has been performing consultancy work for Vygon for several years, during that time they have provided us with a very professional and efficient service. PCL helped Vygon obtain their original Wholesale Dealers Licence and have provided Responsible Person (RP) support to our Quality Team ever since. PCL guided us successfully through our MHRA inspection. More recently, Jackie delivered GDP update training sessions for me and my deputy when I started in my new role as Head of QA/RA. I would recommend PCL to any organisation that needs support in their pharmaceutical operations. Vicky Muir QA/RA Manager Vygon
Very impressed, covered the majority of topics. James Weston – Orderline