Medicines: register to manufacture, import or distribute active substances
How to register as a manufacturer, importer or distributor of active substances.
Overview
Active substances are used to give medicinal products their therapeutic effect and are often called active pharmaceutical ingredients (APIs).
If you manufacture, import or distribute active substances and you are based in the UK you must register with the MHRA. You can do this through the .
To manufacture, import or distribute an active substance you must also comply with good manufacturing and distribution practice (GMDP).
We have produced a requirements to help you decide what kind of registration you need.
You can find out who鈥檚 already registered by checking on .
The registration process
New applications take 60 working days to process, excluding time taken to provide further information or data required.
Variations to registrations that do not need an inspection take 30 working days to process.
If an inspection is required, the inspector will contact you to arrange for an inspection of your site(s).
When the process and inspections - if necessary - are complete, you will receive a registration document.
Change your registration
You must tell us if the details of your original registration change using the .
This change may require an inspection and you will have to pay an inspection fee as well as the variation fee.
New active substances must be added immediately to the registration when there is a potential impact on the safety and quality of other substances. Otherwise you can notify the substances in your annual compliance report.
Annual compliance reports
Registered manufacturers, importers and distributors of active substances must complete an annual compliance report which is due every year on 30 April. Submit the report to us using .
Terminate your registration
To request termination of licence you should complete the聽聽and email it to聽[email protected].
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 惭贬搁础鈥痜别别蝉.
Updates to this page
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Updated fees section to include new fees for 2025.
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Removed 90 day inspection wording.
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Amended to update termination details
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Contact details now include a telephone number, and opening hours. The MHRA address has also been removed.
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Uploaded an updated version of the flowchart on registration requirements, and edited information about access MHRA-GMDP and EUDRAGMDP, following the end of the transition period.
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First published.