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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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“Great Presentation, very informative.”Roshni Rutton-Patel – Course Rating 10/10
Very useful day with a good overview of MHRA GMP & GDP process, procedures and roles and responsibilities.Isatec on site training – Andrew King
We loved your training at Niche!
“Very clear, simple to follow. Interactive. Helpful.”Ade – Rating 9/10
“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
“Excellent, personable and very informative”Anonymous – Course Rating 10/10
“Well structured and presented course. Puveshni was very knowledgeable in the field and benefited her experience.”Abdirahman – Course Rating 10/10
” Very useful day with a good overview of MHRA GMP and GDP process, procedures and roles and responsibilities. Thank you Jackie.”Andrew King – Course rating 9/10
Very informative and delivered well. It was a good introduction into a subject I haven’t dealt with before. Jackie kept the course “light & breezy”
The day was fun and I enjoyed the review of GDP requirements!