Medicines: register as a broker
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Manufacturing, wholesaling, importing and exporting medicines
- 18 December 2014
Apply for and maintain registrations for the brokering of human medicines.
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.
- 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 email@example.com
Fees and payment
The fee payable depends on the number of sites you are registering in your application.
|New application for registration as a Broker||£3157|
|Additional fee if the risk assessment triggers an inspection||£582|
|Assessment of the Annual Compliance Report||£257|
|Annual Compliance where a variation is required||£514|
Telephone: 020 3080 6844
151 Buckingham Palace Road
Published: 18 December 2014