Medicines Healthcare Products Regulatory Agency
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Overview
Active substances are used to give medicinal products their therapeutic effect and are often referred to as active pharmaceutical ingredients (APIs).
If you manufacture, import or distribute active substances and you are based in the UK you must register with the Medicines and Healthcare Products Regulatory Agency (MHRA). You can do this through the MHRA PCL Portal.
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 whos already registered by checking on MHRA-GMDP.
The registration process
New applications take 60 working days to process, excluding time taken to provide further information or data required. If an inspection is needed it will take 90 days.
Variations to registrations that do not need an inspection take 30 working days to process. If the variation needs an inspection it will take 90 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 be issued with a registration document.
Change your registration
You must tell MHRA if the details of your original registration change using the MHRA PCL Portal.
This change may require an inspection and you will have to pay an inspection fee as well as the variation fee.
New active substances need to be added immediately to the registration when there is a potential impact on the safety and quality of other substances; otherwise the substances may be notified 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. The report should be submitted to MHRA using MHRA PCL Portal.
Terminate your registration
To request termination of licence you should complete theand email it topcl@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.
Type of fee
| Active substance manufacturers | |
|---|---|
| New application | 5,006 - includes the application fee 3,143 and the fee for a desktop assessment 1,863 |
| Additional fee if an inspection is required | 792 |
| Variation | 257 |
| Assessment of the Annual Compliance Report | 257 |
| Annual Compliance Report where a variation is required | 514 |
| Active substance importers and distributors | |
|---|---|
| New application | 3,157 - includes the application fee 1,803 and the fee for a desktop assessment 1,354. Additional fee if an inspection is required 582 |
| Variation | 257 |
| Assessment of the Annual Compliance Report | 257 |
| Annual Compliance Report where a variation is required | 514 |
Updates to this page
Last updated 18 December 2024 +show all updates
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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.