Application for a Wholesale Distribution Authorisation in 2026

The team at Paradigm Shift are often asked what the Wholesale Distribution Authorisation application process is.

Whilst we have written about this subject in the past (Wholesale Dealers’ Application  and Wholesale Distribution Authorisation Explained), we thought it would be helpful to provide a quick refresher!

The WDA Application Process

The updated Medicines and Healthcare products Regulatory Agency (MHRA) Wholesale Distribution Authorisation (WDA) applications portal has been in place for a while now. If you do not already have an account you will need to register on the portal to receive login details.

The registration process is relatively straightforward; you will need the company’s Certificate of Incorporation or VAT Certificate and a letter signed by a company director authorising you as an administrator on behalf of the company.

Navigating the Process Licensing Team (PCL) Portal

It’s easy… when you know how!

The MHRA have helpful guides for Wholesale Distribution Authorisation applicants:

• Document one will help you register on the MHRA portal and can be accessed by clicking this link:

Registering on the MHRA Portal

• Document two (MHRA Guidance Note 6), will help you navigate the application process and submit your licence application to the MHRAand can be downloaded by clicking this link;

Notes and Guidance for Applicants and Holders of a WDA (H)

The Next Steps

Work your way through the MHRA Portal Application screens adding the correct information for your organisation. Ensure that the Responsible Person you nominate has the appropriate 1 years’ GDP experience and can been proven to be competent in GDP, the relevant guidelines, MHRA expectations and National law… the Human Medicines Regulations 2012, as amended.

N.B. The 1 year of experience should be at management level, in a “good” site that is similar to the licence nominated or is a suitable internal promotion for an individual who is not involved in commercial activities, as this can be considered a conflict of interest.

Nominating an RP from a pharmacy collection point (ED pills, inhalers from AAH/Alliance etc, then collected by another wholesaler) for an international freight company or exporter would be ill-advised and could result in a failed assessment, and proposed suspension of the licence as there is no suitable RP in post.

The RP section of the portal has recently been updated and now requires evidence of training to be uploaded, not just listed, so please ensure you have your certificates scanned and ready! You will also need a copy of your passport or drivers licence, your CV and two utility bills.

Please note that a Gold Standard certification means very little without good practical experience, and the proposed RP may need to face an MHRA assessment. Any new RP will be assessed by the inspectorate.

Please also note that once the application for an RP is submitted, that individual is permitted to act as the RP… but for an RPi (Responsible Person (Import)) the individual must be approved BEFORE any RPi activities are carried out.

Include all of the required licence categories and products for your GDP activities. However, do not add things on a ‘just in case’ basis as the MHRA inspector will expect procedures, processes, risk assessments, audits and all relevant training records for these activities. It is also wise to ensure that there are emails or contracts relating to the proposed activity, like export enquiries, or site visit reports, to evidence the need for that category. Prepare any required supporting documentation and submit the form.

Once you have submitted your licence application, the MHRA will review the application and supporting documents and will contact you to advise of the next steps.

Your First Application?

As a first time WDA applicant it is highly likely that the MHRA will perform an on-site audit of your Quality Management System (QMS) and your warehouse facilities. Be sure to have everything in place BEFORE you submit your application.

Responsible Persons who have been named previously on a WDA are unlikely to be required to complete an assessment. However, should your nominated Responsible Person (RP) not have acted as an RP on a WDA previously, an MHRA Inspector will perform an assessment with them to check their knowledge and competency levels. RP assessments are usually conducted via telephone.

Keep in mind that the application to inspection process can take between 60 and 90 days, dependent on the workload of the inspectorate, and whether you have correctly completed your documents. If you make a submission that is incorrect the clock stops on your application.
Please note, you cannot begin pharmaceutical wholesaling activities until your WDA is in place.

Help and Support

The application process isn’t a hugely time-consuming activity if you know what you are doing; however prior proper planning can certainly speed it up and save you time and money.

• Do you need assistance applying for your WDA?
• Would you like a review of your QMS and site prior to submitting your application?
• Could you benefit from a mock MHRA inspection?
• Does your Licence Holder or Responsible Person require formal GDP training, or assessing?

Paradigm Shift Consulting can help!

We have been asked to step in to assist many organisations who have spent significant amounts of time, sometimes over 6 months, trying to get MHRA WDA applications through the system and approved by the MHRA.
With our intervention these organisations were up to speed, all QMS procedures, processes and training in place and they had their operations inspected and WDA approved within six weeks.

Our consultants have many years of experience assisting companies of all sizes, including those with simple or more complex business models, preparing, and submitting WDA applications.

We can create a bespoke package, which will reduce your costs and keep overheads as low as possible. Costs for training when combined with onsite audits, where multiple staff are trained at the same time, are significantly lower when our consultants are already at your site.

Renting conference/training rooms and providing catering at a later date cost extra. Why pay more when we can come to you and get to know your site at the same time?  Alternatively, our award winning training platform, GDPTraining.co.uk, offers a wide range of online GDP specific training courses which include pre and post-training assessments and certificates of achievement for those who meet the pass rate criteria.

We can also assist with the placement of Responsible Persons, Responsible Persons (Import), Deputies to the Responsible Person, Computer System Validation professionals, Trainers, Lead Auditors and Quality Assurance Specialists to support your application.

Contact us using our GDP Wholesale Questionnaire for our list of requirements for your WDA application, and a no obligation chat about your needs, and we can help you move ahead.

Welcome to a new Paradigm!

#wherecommonsenseiscommon