Medicines Healthcare Products Regulatory Agency
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Overview
To be registered as a broker by the Medicines and Healthcare Products Regulatory Agency (MHRA), you must comply with good distribution practice (GDP) and pass regular GDP inspections of your site.
A UK-based company that independently negotiates the selling or buying medicines on the behalf of another company must be registered as a broker. A broker does not:
- buy or sell the products
- own the products
- physically handle the products
Wholesale dealers who want to broker medicines must also register.
You can only broker a medicinal product that has a licence (marketing authorisation).
The MHRA publishes the UK broker register.
Apply to register as a broker of medicines
Apply for registration as a broker on MHRA Submissions.
The registration process
Your application will be sent to the MHRA and should take 90 working days to process.
The MHRA may:
- check the identities of the broker and other named staff
- contact you to arrange for an inspection of your site(s) (the inspection process is similar to that for good distribution practice (GDP) and you will be asked to prepare information in advance)
- interview members of your staff
If there is a requirement for an inspector to conduct an onsite inspection, shortly after the inspection you will receive a letter, with details of any issues raised. When the inspector is satisfied that these issues have been addressed, the MHRA will publish the information on a publicly accessible UK register.
All GDP certificates for UK-based companies are published on MHRA-GMDP.
Update your registration
Tell the MHRA if the details of your original registration changes using MHRA Submissions.
It takes 30 working days to process these changes, which are known as variations.
In some cases, the MHRA will carry out an inspection and the process takes 90 working days.
Annual compliance reports
Registered Brokers must complete an annual compliance report which is due every year on 30 April. The report should be submitted to MHRA via the MHRA Portal.
Termination form
To request termination of licence you should complete theand email it topcl@mhra.gov.uk.
There is no fee for terminating a licence, however to avoid having to pay the annual service fee, you must make the request before 31 December.
Fees and payment
The fee payable depends on the number of sites you are registering in your application.
| Broker registration | Fee |
|---|---|
| New application for registration as a Broker | 3157 |
| Additional fee if the risk assessment triggers an inspection | 582 |
| Inspection | 1936 |
| Standard variation | 257 |
| Assessment of the Annual Compliance Report | 257 |
| Annual Compliance where a variation is required | 514 |
Contact
Email: pcl@mhra.gov.uk
Updates to this page
Last updated 18 December 2024 +show all updates
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Updated to delete removal from register email address
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Amended to add sections Terminate Your Registration and Annual Compliance Reports
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Contact details now include a telephone number and opening hours.
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Following the end of the transition period, we have added links to the MHRA Submissions website.
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Changed responsible person to 'broker'
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Changed MHRA address.
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First published.