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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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.
Case Studies
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Testimonials
I found the course on Training to be a responsible person to be a very well thought and structured course which gave me the roles and resources to come away understanding the training given. It was very informative, topical and saved me time and money trying to wade through a minefield of work to become a responsible person – Jackie is highly qualified and delivers an excellent course, would highly recommend to anyone looking at wholesaling.
“Excellent training, thorough explanations and enjoyable throughout.” David Lane – Course Rating 9/10
“As a nurse adviser I wasn’t sure of the relevance to my role. It was interesting and I learned a lot.” Course Rating 6/10
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
Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it seem harmless enough, though clearly wrong. I truly believe that we should all expand our knowledge and understanding as much as possible, and certainly where there are crossovers with our speciality. For a Pharmacist or wholesaler, knowing more about GMP, APIs and Clinical Trials must be useful in our ability to fulfil our obligations in our own field. Yes, some aspects of GMP are very technical but there are big parts of it that can be used positively in the GDP arena. As my exasperated tutors used to say during my pharmacy degree, “you will only get the most out of the topic and excel, if you read around the subject”.
“Excellent trainer, very informative.” Anonymous – Rating 10/10
Jackie from PCL has the experience and ability to support new and existing pharmacy businesses unlike any other.
“Very Informative course. I have learnt a lot of new information and the training was given in a relaxed environment. Thank you for making the learning as interesting as possible.” Megan – Course Rating 10/10
“Excellent and well run course, we covered a lot of information in a structured and detailed fashion. Steven our trainer, was super knowledgeable and always happy to interact with the group and answer questions during the sessions. Many Thanks” – Cogent RP Training – October 2024
“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
We loved your training at Niche!
“Well prepared and delivered presentations which were insightful, interesting and helpful to any new RP.” – January 2021
“The trainer was knowledge and answered all questions thrown at him. Training was interactive and everyone engaged. Thank you Steve for a wonderful training session.” Introduction to the RPI Role – August 2021
I am new to GDP and the trainer was very patient with my endless questions and answered them all with rounded practical answers that i can take back to my workplace and implement. Shirley Clifton – Ashford and St Peters Hospital
“An ‘All-Inclusive’ Training” Pop Ohelga – Course Rating 10/10
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
Informative & Interactive. Thank you.
“Steve is a fantastic trainer with a wealth of knowledge and the ability to be able to apply that knowledge to real life situations. Fantastic course extremely well delivered. Thank you.” – MM, Kuehne+Nagel – Cogent RP Training – April 2024
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
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”
“This is the pharma cogent course “ronseal” excellent through the whole process”
“Good informative training, very helpful for the future.” GDP Online Training – May 2021
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
The GPD session at PCL enabled me to focus on the really important things when it comes to getting your wholesale licence. Dawn structured the workshop in a very lively and interactive way so it is easy to follow and to use her ideas for your own business. It was very helpful, I decided to book the Audit training too.
“Very informative and very helpful. Brian was very professional and very patient with our numerous questions. Thank you.” Catherine Hodges – Course Rating 10/10
Sandeep has a great knowledge of the subject “A good course”. Thanks. 24/04/2019 – Guy Spires from PRS distribution
“Very informative course. Well worth attending.” Dave Smith 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.
“Excellent course, trainer and material were superb.” – KT, Hameln Pharma Ltd – Cogent RP Training – April 2024
“A relaxed training environment, and competent instructions, enabled me to gain full knowledge of what i can expect for future MHRA inspections.” David Briggs – Course Rating 9/10
Brilliant training provider, extremely helpful, knowledgeable and fantastic course delivery. 02/06/2020
“Really enjoyed the training session over the last 3 days, John was a great presenter who did really well considering he had an audience from all over the UK…infact the world! I’m sure the face to face/classroom style presentation would have been more interactive as I certainly missed being able to bounce off others but this is no fault of John or the course contents. Learned so much from the past few days, more than I actually realised that I would. Thank you!” February 2021
“Good Training day, thank you.” Course Rating 10/10
“Training was well laid out and followed a great structure. The trainer was very very good and very attentive”
Very interesting presentation which allowed me to gain a proper overview of the GDP process. Isatec on site training – Jack Shock
The course covered all areas I was expecting and very well presented considering how it was delivered during the current situation. Clare Durbin 12/05/2020
“Excellent refresher, very informative. Thank you.” Addy Mohammed – Course Rating 10/10
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. Great handouts to take away. Thanks” Megan – Course Rating 10/10
“The training was well structured and everything covered was relevant and will be easily applied to our working environment. The trainers were very knowledgeable and ensured there was interaction from the group throughout. The time length of the course was perfect and this helped with keeping the group engaged. Would highly recommend this course/structure.” – VR – UHB NHS Logistics, CD Training, September 2024
I attended the GDP Responsible Person Cogent “Gold Standard” training course and found it very informative, the trainer was very knowledgeable and answered all questions to a high standard, I learnt all aspects of GDP and gained knowledge that will help me greatly within my role at work and in an RP Role. 10/10
“An excellent course with almost 1/1 training. Interactive, knowledgeable trainer. Excellent venue.” Dr. Parry – Course Rating 10/10
“Brian is very thorough and very informative. Interactive too. A++++, Highly recommended” Anonymous – Course Rating 9/10
“I really enjoyed the course and will recommend it highly to anyone planning to apply for WDA or training to become RP. The Tutor was very knowledgeable and experienced. I learnt so much from the training so I can only thank you.” Cogent Online Training – March 2022
“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
“Very Informative and useful session” Rahinatu – Course Rating 10/10
“Great delivery by Brian, thought his presentation was well spoken and easy to follow, impressed with his knowledge on tricky Q&A” – GDP, October 2023
“Brilliant training provided, answered all questions.” Ashish Morar – Course Rating 10/10
“Excellent from start to finish – 5 stars!” Cogent Online Training – February 2021
The trainer was highly skilled and professional. We now feel very well informed and supported to start our critical GDP inspection.
“Excellent, personable and very informative” Anonymous – Course Rating 10/10
“Very efficient and effective. Covered all areas of training.” – John Elliott KWE
Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
“Enjoyed the course. Informative and interesting. Presented in an engaging way that encouraged questions and dialogue. Would recommend it to others” – Cogent Responsible Person Training – February 2024
“Many thanks to Brain the trainer” Wagdi Moussa – Course Rating 9/10
“Great course from a knowledgeable trainer. Remote webinar worked perfectly and still enabled interaction and group discussion. Trainer was also extremely helpful with advice after the course was over. Would recommend to anyone” Cogent Online Training – April 2021
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 !
“RP training at PCL helped me to understand current MHRA guideline to fill my knowledge gap. The trainers are really experienced and updated with current pharmaceuticals wholesale regulations.” – January 2021
Our trainer Jackie was extremely knowledgeable and very interesting. If I ever require help or further assistance, I would not hesitate to contact Jackie and I would certainly recommend her for the services as a consultant and higher knowledge.
“Course was very informative and taught/explained very well.” Craig – Course Rating 9/10
“The training was very informative and well-structured. I found it to be both engaging and relevant to my role. The material was clear, and the examples provided were helpful in understanding the key concepts. I especially appreciated the practical application tips shared. Brian did an excellent job of explaining complex topics in an easy-to-understand manner. The pace was just right, and the interactive elements kept the session engaging. I`m so glad I`ve decided to have the training face to face, it really makes a difference in terms of engagement.” – Cogent RP Training – November 2024
“Wes was brilliant, encouraged us to be interactive and answered all the questions we posed. She was positive and patient. Fantastic trainer”
Ash our trainer was very knowledgeable, friendly and helped us greatly on our training course, highly recommended. 10/10
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
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 Fox DX (Group) plc
“Covered all questions i had. I left with full knowledge on the topic.” Anonymous – Course Rating 8/10
I think the PCL course dovetails very well with wholesaling as it provides practical course material with a good eye to Quality Management, which is the concern of our company with the MHRA inspection process beginning soon.
‘Really informative, knowledgeable and interactive. Would recommend.’ Rachel Bown
Our trainer Jackie was extremely knowledgeable and the way how the material was presented was very interesting. I found her also very helpful, explaining every questions and doubts perfectly. I would highly recommend Jackie as a trainer and also as a consultant.
“Excellent course and extremely practical.” Online Cogent, March 2021
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.
“A really useful day.” Martin – Course Rating 10/10
“Good training, has given me more insight as an RP. Would recommend new RP’s to have this training.” Matthew – Course Rating 10/10
Very informative. Thank you.
It was an absolute pleasure to meet with you and we are delighted given the extent of your contribution. There were many positive comments concerning your overall contribution. And as you are aware the workshops were exceptionally interesting for the audience. But also many colleagues made direct comments concerning your presentation which was rated as a highly clear and concise.
“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
“Excellent delivery and trainer is very knowledgeable.” Anonymous – Course Rating 10/10
Thoroughly enjoyed the course! Meallad Davoud 05/05/2020
“Well structured and presented course. Puveshni was very knowledgeable in the field and benefited her experience.” Abdirahman – Course Rating 10/10
“Very well presented and detailed course. A lot of my questions were answered.” Anonymous – Course Rating 9/10
Pharmacy Consulting has helped manage our Company through all GDP compliance and RP training requirements, It is a pleasure to work with such a dedicated team. 10/10 –
“Excellent content and delivery. Answered all questions with good detail.” Course Rating – 10/10
“Excellent from start to finish – 5 stars !”
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
Lots of information and keeps you engaged. Isatec on site training – Abbey Tullett
“As participants, we were all able to interact, engage and shared a worth of knowledge and opinion from various industries. This made the sessions very informative, valuable and interesting.”
“Steve was really engaging and gave really good examples within industry and real life, Making the content relatable and understandable.” – MH, Kuehne+Nagel – Cogent RP Training – April 2024
Pharmacy consulting helped us to map our warehouse and also to map our new pharmacy fridge they were much cheaper that the other quotes we had and they also trained up the staff on the cold chain SOPs we had jointly written. Thank you Jackie for all your help!
” Very interesting presentation which allowed me to gain a proper overview of the GDP process” Jack – Course Rating 9/10
“The API training course provides a good framework foundation focused on API distribution. I only wish I had found the API course much earlier, it would have saved me months of puzzling on some issues relating API importation and distribution. I am a novice when it comes to Medicinal product regulatory compliance. For months I have been rolling in the Green Guide but the Green Guide focuses mostly on Finished Form medicine, so I end up with just as many questions at the beginning, albeit a different set of questions. The API course finally answers my fundamental questions on API distribution, and yes I have a plenty of Q&A time with the trainer which is of great benefit to me. I am so pleased with the API course, I immediately start working with one of their consultants on specific issues I face in my company. .” Yu Wang, Donglun Ltd – API Training, July 2021
“Index the presentation to be able to reference quicker – detailed key acronyms. Good course, very enlightening for understanding and questioning current processes within our company.” Craig Buzzard – Course Rating 9/10
Very informative. Was hesitant about attending but very happy I did. Jackie was excellent.
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 & Johnson 05/05/2020
“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
“Great Presentation, very informative.” Roshni Rutton-Patel – Course Rating 10/10
“Very informative and lots of opportunity to ask questions and speak with other people on the course.” Megan – Course Rating 10/10
John Finey was excellent & encouraged two-way training e.g. specific experiences the attendees had encountered in their working lives. 18/02/2020
“The training was concise to the point and left plenty of room for questions. 1 week later and already applying it to my day to day.” – Audit Training, September 2021
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 Funnell Director Universal PS
“Nice Chap, explained everything in an easy to understand manner!” Andrew Kruinlger – Course Rating 10/10