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Wholesale Dealers Licence (WDL or WL) has been replaced by Wholesale Distribution Authorisation (WDA).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
Please click on the links below to view full details of each case study.
Testimonials
“The gem is the trainer’s real world prospect on MHRA Inspector’s expectations” Cogent Online Training – July 2021
Cogent - July 2021
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
Testimonial from Zdenek Schmittz- Pharma Group Europe
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.
Independent community pharmacy owner
A very informative overview of GDP and the role of the RP. Great to be able to discuss GDP issues with Brian and with others on the course.
Alastair Farquhar
“Well prepared and delivered presentations which were insightful, interesting and helpful to any new RP.” – January 2021
Cogent - January 2021
“My experience working with Steven has been calm and reassuring. I have struggled to find specific requirements for API distribution from my previous consultant and the Green Guide. I start working with Steven shortly after taking an API training course at PCL, the consultation is beyond my expectation, he helps me identify my specific set of issues quickly and advise me how I should address them to achieve compliance. In the short time I am working with Steven gives me clarity that I have not managed from my previous consultant in months. Steven tirelessly explains the whole process to me which is of great benefit, I am much more aware what my issue are and what needs to done to address them. In my mind, Steven is like an guide and companion en-route to compliance, he asks the right questions, explains well and helps me find practical solution. His experience and problem solving skills shines through and makes consulting stress less and pleasant. ” Yu Wang, Donglun Ltd – PCL Consultancy Services
Consultancy Services
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
Sonia Garcia Scriano - Caligorrx
“Very informative training day.” “Highly recommended”
Manus Mulligan
“A really useful day.” Martin – Course Rating 10/10
GDP RP Training
“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
CD Training - Well Structured and Relevant
“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
API Training
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply. Isatec on site training – Bill Castle
GDP/RP Training
“Good Training day, thank you.” Course Rating 10/10
GDP & RP Training
“I would like to thank Brian for coming up to us – he made a difficult subject easy to understand and also helped us with real life scenarios – not just following the curriculum, which whilst hurt our timescales – was much more beneficial for us.” Cogent (Face to Face) Training – November 2021
Cogent (Face to Face Training)- November 2021
“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
GDP & RP Training
“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
Cogent Gold Standard Responsible Person Training
“Excellent course, trainer and material were superb.” – KT, Hameln Pharma Ltd – Cogent RP Training – April 2024
Relatable and Understandable Content
‘Really informative, knowledgeable and interactive. Would recommend.’ Rachel Bown
GDP/RP Training
“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
GDP & RP Training
“Really well presented and explained. Have a much better understanding of a very involved subject.” Vicky Stones 10/10
Export Training
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
Ross Johnston from Survitec
Very useful day with a good overview of MHRA GMP & GDP process, procedures and roles and responsibilities. Isatec on site training – Andrew King
GDP/RP Training
“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
GDP & RP Training
“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
GDP & RP Training
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.
Testimonial from Link Medical Limited, Bramshill
“Excellent training, thorough explanations and enjoyable throughout.” David Lane – Course Rating 9/10
GDP & RP Training
“For someone with a bare minimal knowledge of WDA this course helped understand the legal, general and business complexities quite well.” Cogent Online Training – March 2021
Cogent - March 2021
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”
Gemma Carnie from Survitec
“Wes was brilliant, encouraged us to be interactive and answered all the questions we posed. She was positive and patient. Fantastic trainer”
Cogent Responsible Person, December 2020
“Very Informative and useful session” Rahinatu – Course Rating 10/10
Export Training
“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
Fantastic course extremely well delivered
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
Testimonial from Farah Mohamed Community Pharmacist
“Very informative course. Well worth attending.” Dave Smith 9/10
Export Training
“Good training, has given me more insight as an RP. Would recommend new RP’s to have this training.” Matthew – Course Rating 10/10
GDP & RP Training
“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
Excellent and Well Run Course
Jackie has the experience and ability to support new and existing pharmacy businesses unlike any other.
Phil LawesSuperintendent Pharmacist
“MHRA GDP guidelines are numerous and specific and potentially serious if not followed. The training went through each point in a common sense way, so the guidelines have appeared far more admirable and attainable.” Philip Hodgkinson – Course Rating 10/10
GDP Training
Very informative. Thank you.
Katie Wenlock - Link Medical
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.
Chapelle RaoulStowhealth
“Excellent from start to finish – 5 stars!” Cogent Online Training – February 2021
Cogent - February 2021
Informative & Interactive. Thank you.
Rima Gupta from Mode Pharma
Ash our trainer was very knowledgeable, friendly and helped us greatly on our training course, highly recommended. 10/10
Cogent Gold Standard Training
Thoroughly enjoyed the course! Meallad Davoud 05/05/2020
Cogent Gold Standard GDP Online Training
“Brilliant training provided, answered all questions.” Ashish Morar – Course Rating 10/10
GDP & RP Training
“An ‘All-Inclusive’ Training” Pop Ohelga – Course Rating 10/10
GDP & RP Training
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
Pharmacy developing patient services
“Many thanks to Brain the trainer” Wagdi Moussa – Course Rating 9/10
GDP & RP Training
Brilliant training provider, extremely helpful, knowledgeable and fantastic course delivery. 02/06/2020
Cogent Gold Standard GDP Online Training
“An excellent course with almost 1/1 training. Interactive, knowledgeable trainer. Excellent venue.” Dr. Parry – Course Rating 10/10
GDP & RP Training
“It is always difficult to provide and undertake virtual training. Wes did well getting through all the material and encouraged interaction among the group. This was difficult but at times good discussion did open up. There were no technical difficulties in terms of the training provision, and everything ran to time, if not a bit quicker than expected. I did enjoy it and remained engaged throughout. There was a lot of content and to begin with I felt a little overwhelmed and anxious about the five assessments looming at the end. However Wes reassured us that we had the info we would be needing and rather than worry about taking notes, better to listen and take in the lesson. Which worked. I gained some useful insights which I will take back to work. I go back feeling much better equipped to aid the RP with our QMS.” November 2020
Cogent Gold Standard Responsible Person Training - Nov 2020
Kim was helpful at answering all my questions and advise on how to do things independently or with the help of PCL.
Testimonial from a Pharmacist Trainee
“Very well presented and detailed course. A lot of my questions were answered.” Anonymous – Course Rating 9/10
GDP & RP Training
“The trainer Wes was amazeballs. She showed deep knowledge in the subject matter and was very engaging”
Cogent Gold Standard Responsible Person
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
GDP/RP Training
“Very informative course, well laid out and very educational throughout the whole course.” – Cogent RP Training, September 2024
Informative and well laid out course
Well structured and presented course. Puveshni was very knowledgeable in the field and benefited from her experience. Abdirahamn Sheikh – Irmaan
GDP/RP Training
“Very informative and very helpful. Brian was very professional and very patient with our numerous questions. Thank you.” Catherine Hodges – Course Rating 10/10
GDP & RP
“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
Intro to RPi Role - Aug 2021
Again, I stress how much I appreciate all your help, both today and through the whole journey of us striving to obtain our WDA(H).
Michael OgundeleAderemi Healthcare Ltd.
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
Chrissie Sharman - Caligorrx
“I really enjoyed the 3 days training, it has made me think about my new role and how I’m going to apply this knowledge and take it forward.” – January 2021
Cogent Gold Standard Responsible Person Training
“Very efficient and effective. Covered all areas of training.” – John Elliott KWE
GDP/RP Training
“Excellent delivery and trainer is very knowledgeable.” Anonymous – Course Rating 10/10
GDP & RP Training
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.
Testimonial from David Burns
” Very fun, interactive course. Trainer was very approachable.” Farhan Masoud – Course Rating 9/10
GDP & RP Training
“Steven ensured class participation and sharing of case studies within our group. Kept everyone motivated. It was interesting for me to see what my customers need to do to remain GDP compliant after delivering Imports and before collecting their Exports. ” – JS, Nippon Express (UK) Ltd, Cogent, January 2025
Cogent RP Training - January 2025
“This is the pharma cogent course “ronseal” excellent through the whole process”
Cogent Responsible Person, December 2020
The trainer was highly skilled and professional. We now feel very well informed and supported to start our critical GDP inspection.
From Frank Carter Asante
“Course was very informative and taught/explained very well.” Craig – Course Rating 9/10
GDP Training
“Brian is very thorough and very informative. Interactive too. A++++, Highly recommended” Anonymous – Course Rating 9/10
GDP & RP Training
‘Really clear and concise and very helpful to point out how much work is still required of us. A great start to the RP journey.’ Jon Barden
GDP/RP Training
“Very helpful, clear, and precise. Thank you.” Rachel Wicks – Course Rating 10/10
GDP & RP Training
Very interesting presentation which allowed me to gain a proper overview of the GDP process. Isatec on site training – Jack Shock
GDP/RP Training
“Excellent training sessions provided. I have thoroughly enjoyed and learned in all sessions. Steven presented and taught the content very well and was very knowledgeable about all topics, and supported further with any adhoc questions through the training. Thank you :)” – Cogent RP Training – April 2024
Excellent Training Sessions
Waisain Al-Shamary was a lovely tutor – she allowed people to contribute and she managed a couple of strong characters with grace and patience – December 2020
Cogent Gold Standard Responsible Person Training
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”.
API and Clinical Trails Training
A lot of valuable information to digest. Thank you Anna Drys – Oxford Hospital
GDP/RP Training
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
Pharmaceutical Transportation
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
Testimonial from Universal PS
“Covered all questions i had. I left with full knowledge on the topic.” Anonymous – Course Rating 8/10
GDP & RP Training
“Training was well laid out and followed a great structure. The trainer was very very good and very attentive”
Cogent Gold Standard Responsible Person Training
“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
Face to Face Training: Informative and Well Structured
John Finey was excellent & encouraged two-way training e.g. specific experiences the attendees had encountered in their working lives. 18/02/2020
Cogent Gold Standard GDP Online Training
“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.”
Cogent, Dec 2020
“Very informative and lots of opportunity to ask questions and speak with other people on the course.” Megan – Course Rating 10/10
GDP & RP Training
“Very clear, simple to follow. Interactive. Helpful.” Ade – Rating 9/10
Export Training
“Excellent content and delivery. Answered all questions with good detail.” Course Rating – 10/10
GDP & RP Training
“Mr. Brian Lindsay has been a down to earth trainer. His approach to the GDP and training has been excellent, and i personally have gained a wealth of knowledge that made me appreciate what GDP actually means.” Mr Sanjay Budhdeo – Course rating 10/10
GDP & RP Training
The course is very informative and comprehensive which covers all aspects of EU GDP guidelines.
Haidar Al-Bukhari
“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
GDP & RP Training
Very good content and well presented.
Andrew Galloway
“Lot’s of information and keeps you engaged.” Abbey Tullett – Course Rating 10/10
GDP Training
The day was fun and I enjoyed the review of GDP requirements!
Nancy Nielson from Idis
“Great Presentation, very informative.” Roshni Rutton-Patel – Course Rating 10/10
GDP & RP Training
“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
Informative and Interesting
“Excellent, personable and very informative” Anonymous – Course Rating 10/10
Export Training
Good knowledge and practical insight into the requirements.
Simon James
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
Cogent Gold Standard GDP Online Training
“Good informative training, very helpful for the future.” GDP Online Training – May 2021
GDP Training - May 2021
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.
Cogent Gold Standard Training