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

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

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 Submission databasePortal.

Termination form

To request termination of licence you should complete the  Termination Form (MS Word Document, 756 KB) and email it to pcl@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 Findregistration	Fee
New outapplication morefor aboutregistration as a Broker	£3157
Additional fee if the feesrisk weassessment chargetriggers atan MHRA fees. inspection	£582
Inspection	£1936
Standard variation	£257
Assessment of the Annual Compliance Report	£257
Annual Compliance where a variation is required	£514

Make a payment to the MHRA

Contact

Email: pcl@mhra.gov.uk