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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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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This session has been very informative and an eye opener. Jackie was excellent in her delivery.
It was a great pleasure to deal with Pharmacy Consulting Ltd (PCL).I would recommend PCL to everyone especially young entrepreneurs about to embark upon owning their own pharmacy, be it in community pharmacy or Internet pharmacy.I valued the advice and motivation that PCL has given me to pursue my dreams.PCL’s knowledge in pharmacy regulation is vast and up to date and I will definitely use PCL again for my future projects
Very impressed, covered the majority of topics.James Weston – Orderline
“Excellent content and delivery. Answered all questions with good detail.”Course Rating – 10/10
” Very interesting presentation which allowed me to gain a proper overview of the GDP process”Jack – Course Rating 9/10
Great training session provided by Jackie. Could consider providing additional training material (sample forms and documents) for clients apart from the GDP guidelines.
Well structured and presented course. Puveshni was very knowledgeable in the field and benefited from her experience.Abdirahamn Sheikh – Irmaan
“I found this course much more interesting and accessible than i thought it would be. Nicely paced with enough information to be challenging and thought provoking but not overwhelming. A few of the initials could do with explaining though.”Jennifer Kirby – Course Rating 9/10
Kim was helpful at answering all my questions and advise on how to do things independently or with the help of PCL.
We appointed PCL to assist us with our new CQC compliance registration. From start to finish, they acted with professionalism and expertise; taking what at first seemed to be a tedious and daunting process and making it clear and easy to understand. Even after our successful registration, the consultant remained on hand to answer any outstanding questions and to ensure that we felt adequately prepared for a potential visit from the CQC. Having had such a positive experience, we have no hesitation in recommending PCL to any company who is considering their services