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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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A lot of valuable information to digest.Thank youAnna Drys – Oxford Hospital
“I am new to GDP and the trainer is very patient with my endless questions and has answered them all with rounded practical answers, that I can take back to my workplace and implement it.”Shirley Clifton – Course Rating 10/10
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
Lots of information and keeps you engaged.Isatec on site training – Abbey Tullett
“Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.”Bill Castle – Course Rating 9/10
“Many thanks to Brain the trainer”Wagdi Moussa – Course Rating 9/10
“This one day training package cover, including Good Distribution Practice (GDP) and Responsible Person (RP) roles and responsibilities, ‘packed a punch!’ Well structured, well delivered and interactive. Good value for money. Good day out overall.”Anonymous – Course Rating 8/10
The course is very informative and comprehensive which covers all aspects of EU GDP guidelines.
I want to thank you again for your successful presentation made in London to our Pharma Group Europe conference.Your detailed explanations for all the delegates were extremely interesting and enlightening.Our international participants from Germany, Austria, Switzerland and Romania expressed their praise and encouragement. Zdenek Schmittz- Pharma Group Europe
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