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 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 Portal.

To manufacture, import or distribute an active substance you must also comply with good manufacturing and distribution practice (GMDP).

We have produced a flowchart on the registration requirements (PDF, 37.9KB, 1 page) requirements to help you decide what kind of registration you need.

You can find out who’s already registered by checking on EUDRAGMDP.

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 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 Portal.

Terminate your registration

To end your active substance registration you should email pcl@mhra.gsi.gov.uk.

Fees and payment

The fee payable depends on the number of sites you are registering in your application.

Make a payment to MHRA

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

Contact

Process licensing (PcL) enquiry line

5-Y
151 Buckingham Palace Road
London
SW1W 9SZ

For enquiries from manufacturing and wholesale dealer licence holders, brokers and active substance manufacturers, importers and disitributors (and their representatives) about their licences.