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Jul 6, 2016

Wholesale Distribution Authorisations with Mawdsleys

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all
medicines and medical devices in the UK, by ensuring they are safe and that those manufacturing,
storing and distributing them are fit to do so. It is compulsory that all UK pharmaceutical manufacturers and distributors undergo a system of licensing and inspection to certify their products are safe, and ensure that they work in compliance with regulatory requirements.

Applications for a Wholesale Dealers Authorisation (WDA), are assessed by the MHRA and take around
90 working days to process. The MHRA will check the identities of the Responsible Person (RP), and
confirm the registered details of the company with Companies House. Prior to the granting of a WDA, the
MHRA will inspect the applicant’s premises and quality systems, as well as ensure the suitability of the
nominated RP.

Shortly after the inspection the MHRA will issue a report with details of any deficiencies raised. When theinspector is satisfied that these issues have been addressed, the MHRA will grant registration and issue aWholesale Dealers Authorisation. Each inspected site will also receive a Certificate of Good DistributionPractice (GDP) Compliance.

Here at Mawdsleys we offer a bespoke service to help assess your WDA needs, as well as assist you in the
application process. We understand that this is a lengthy procedure and aim to work with you to share
the workload. Firstly, we will evaluate your need for a WDA which may include a premise inspection
and evaluation. We will train you in practices regarding compliance with the MHRA regulations before
the official inspection takes place. Applications can only be made through the MHRA Process Licensing
Portal, accessible via the MHRA website. We can support you in every step of this process until the
application has been completed and submitted. Not only this, but we can help with the provision of a
responsible person. Our guidance will ensure your Wholesale Distribution Authorisation application runs
as smoothly possible.

If you have any queries regarding your WDA please do not hesitate to contact Michelle Biggs (Group
Regulatory Services Manager / EU Responsible Person) at michelle.biggs@mawdsleys.co.uk.

Helping ensure patients have access to the drugs they need, when they need them.

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