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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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.
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
“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
/”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
Just wanted to say thank you for the training last week, was education and fun, and it was great to be able to spend time with a professional auditor.
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.
Since 2012 we have been using PCL for regulatory support, staff resourcing, training and general advice. We have consistently found that the whole team has a high level of technical competence, are always willing to get stuck in to help us and are able to come up with robust ideas to improve our systems. I would have no hesitation in recommending their services in any of these areas.
“Very clear, simple to follow. Interactive. Helpful.”Ade – Rating 9/10
Pharmacy Consulting provided us with a very professional and efficient service over a number of extremely busy months. Not only were they flexible to our requirements but also to our workloads, time schedules and finances. Jackie Peck in particular was extremely aware of our needs and outcome requirements. For a small company such as ourselves this was invaluable. At all times Pharmacy Consulting kept us informed of any amendments, changes, monetary matters and as the client we felt it was a very professional service. The intended outcome was successfully achieved and the team at Pharmacy Consulting went above and beyond their duties as consultants for us. I cannot recommend them enough.
Very good informative trainer, excellent delivery on a rather dull topic. Kept our interest well which helped with learning. Jackie answered every questions I had. Thank you
Pharmacy consulting helped us to choose the robot that best suited our requirements and it can be added to at a later date, my regular locum has rescinded his notice as he cannot cope better with the volume of prescriptions we dispense and he gets to sit down to work !