# Medicines: register as a broker

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/300ae706-bf71-421a-b9bd-eb5151be4ecb
Type: Detailed Guide
Published: December 18, 2014
Updated: April 1, 2025

> This guidance from the Medicines and Healthcare Products Regulatory Agency (MHRA) details the registration requirements for UK-based companies acting as medicinal product brokers. Under the regulatory framework of Good Distribution Practice (GDP), a broker is defined as an entity that independently negotiates the sale or purchase of medicines without owning or physically handling the products. To gain registration, applicants must submit a request via the MHRA Submissions portal, which typically involves a 90-day processing period. During this time, the MHRA conducts background checks on staff and may perform onsite inspections to ensure compliance with GDP standards. If an inspection identifies specific issues or violations, the applicant must resolve these findings to the inspector's satisfaction before the registration is finalized and published on the UK broker register. Ongoing requirements for registered brokers include the submission of an annual compliance report by April 30th each year and notifying the agency of any changes to their registration details through a variation process. Additionally, companies must pay registration fees based on the number of sites involved and can terminate their registration by submitting a formal request before December 31st to avoid annual service charges. Professional adherence to these standards ensures the integrity of the pharmaceutical supply chain within the United Kingdom.

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## Content

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 Submission database . 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. Find out more about the fees we charge at MHRA fees . Make a payment to the MHRA Contact Email: pcl@mhra.gov.uk

## Attachments

- [Termination Form ](https://assets.publishing.service.gov.uk/media/6762fa3c4e2d5e9c0bde9b48/Termination_form.docx)
