Medicines: register to manufacture, import or distribute active substances

Overview

Active substances are used to give medicinal products their therapeutic effect and are often called active pharmaceutical ingredients (APIs).

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, 113 KB, 3 pages) requirements to help you decide what kind of registration you need.

You can find out who’s 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.

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 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 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 MHRA PCL Portal.

Terminate your registration

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.

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Type of fee

Active substance manufacturers
New application	£5,006 - includes the feesapplication wefee charge£3,143 atand MHRA fees. 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

Make

Active substance importers and distributors
New application	£3,157 - includes the application fee £1,803 and the fee for a paymentdesktop toassessment MHRA £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