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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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.
“A very small group (2 of us attending) but this was excellent! Very interactive course, very informative. Gained a lot of information to take away. Thank you very much.”Jane Lytwynchuk – Course Rating 10/10
Both Jackie and Sandeep made it really easy to understand the content – they encouraged discussion but also made sure that focus was given to areas specific to the attendees. Overall I enjoyed the course and found it far less overwhelming than I expected.
I found Pharmacy Consulting Ltd’s (PCL) input into the planning and installation of our ARX V Max extremely beneficial to the project.The senior consultant from PCL met with me, the ARX project manager, and members of my shop fitting team, and we discussed the new pharmacy planned layout from PCL’s automation experience. This was useful as having previously worked with robots, and also being a pharmacist he could provide valuable advice on where the machine outputs would be best positioned for the best workflow.He returned to the pharmacy when we were up and running and observed the processes that we had developed and spoke to all the staff and got a good feel of how we were working. Having read his subsequent report, all his ideas seemed to make sense and I shared his report with all of my staff and we successfully implemented the suggested changes.
Good knowledge and practical insight into the requirements.
Informative & Interactive. Thank you.
I attended one of the first virtual GDP Responsible Person Cogent “Gold Standard” training sessions due to the Covid-19 social distancing requirements. regardless of the circumstances the training was well organised and delivered to the required standard. This is why I recommended my associates to utilise PCL. Thank you Ryan, Sally, Adel and Jackie.Goncalo Sousa – Quality Head UK at the Janssen Pharmaceutical Companies of Johnson & Johnson05/05/2020
“Excellent delivery and trainer is very knowledgeable.”Anonymous – Course Rating 10/10
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 MuirQA/RA ManagerVygon
Thoroughly enjoyed the course!Meallad Davoud05/05/2020
“Excellent refresher, very informative. Thank you.”Addy Mohammed – Course Rating 10/10