Guidance

Medicines: register as a broker

Apply for and maintain registrations for the brokering of human medicines.

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).

MHRA publishes the UK broker register.

Apply to register as a broker of medicines

Apply for registration as a broker on the Heads of Medicines Agencies website.

The registration process

Your application will be sent to MHRA and should take 90 working days to process.

MHRA may:

  • check the identities of the ‘responsible person’ 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

Shortly after the inspection you will receive a report, with details of any issues raised. When the inspector is satisfied that these issues have been addressed, MHRA will publish the information on a publicly accessible UK register.

All GDP certificates for UK-based companies are published on the European Medicines Agency website.

A broker’s registration is recognised by other Member States and can be used to broker within the European Econonic Area (EEA).

Update your registration

Tell MHRA if the details of your original registration changes using the Heads of Medicines Agencies website.

It takes 30 working days to process these changes, which are known as ‘variations’.

In some cases, MHRA will carry out an inspection and the process takes 90 working days.

To request removal from the register, email pcl@mhra.gov.uk

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

Make a payment to MHRA

Contact

Email: pcl@mhra.gov.uk

Telephone: 020 3080 6844

PCL Enquiries
MHRA
10 South Colonnade
London
E14 4PU

Published 18 December 2014
Last updated 18 June 2018 + show all updates
  1. Changed MHRA address.
  2. First published.