Applying for your Wholesale Dealers Licence

The Wholesale Dealers’ Authorisation License Application Process

The updated Medicines and Healthcare products Regulatory Agency (MHRA) Wholesale Dealer 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 for login details.
The registration process is easy, 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 put a helpful guide online which we have hosted here as an easy to use pair of PDF documents.

• Document one will help you register on the MHRA portal and can be downloaded by clicking this link; Registering on the MHRA Portal
• Document two will help you navigate the application process and submit your licence application to the MHRA and can be downloaded by clicking this link; Submitting your WDA application MHRA Portal

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

Next Steps

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, which is likely to include an on-site audit of your Quality Management System and your warehouse facilities, so be sure to have everything in place BEFORE you submit your application!

Do you need assistance applying for your WDA? The application process isn’t a hugely time consuming activity, however prior proper planning can certainly speed it up and save you time and money.

Would you like a review of your QMS and site prior to submitting your application?

Paradigm Shift Consulting can help! 

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

We can create a bespoke package, reducing your costs and keeping overheads as low as possible. Costs for training can be combined with site audits, and multiple staff can be trained at a reduced cost – even lower if you host our consultants at your site. Renting conference/training rooms and providing catering costs extra… why pay more when we can could come to you and get to know your site at the same time?

We can even 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. Do you have commercial concerns? Although Paradigm Shift Consultants cannot help you with sales, we can offer support with locating suppliers and managing your quality system, which can lead to reduced costs and increased profits.

One of our recent clients had spent almost five months trying to get his application passed. With our intervention he was up to speed and inspected within six weeks!

Bear in mind that from application to inspection it can take from 60-90 days, depending 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 and can delay you.

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