# Medicines: register to manufacture, import or distribute active substances

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d58154fb-b93f-42be-8d62-90636e845f02
Type: Detailed Guide
Published: December 18, 2014
Updated: April 1, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for UK-based organizations manufacturing, importing, or distributing active substances used in medicinal products. Under the UK regulatory framework, all such entities must register via the MHRA PCL Portal and strictly adhere to Good Manufacturing and Distribution Practice (GMDP) standards. While this document is general guidance rather than a report on a specific company, it establishes the mandatory protocols for maintaining legal operation. Key required actions include completing the initial registration, which typically takes 60 working days, and updating registrations when details change. Variations requiring no inspection are processed in 30 days. Organizations must also submit an annual compliance report by April 30 each year. If an inspection is deemed necessary, the MHRA will coordinate a site visit, which incurs additional fees. To avoid annual service charges when closing operations, termination requests must be submitted by December 31. Failure to comply with these registration and reporting standards or failing to meet GMDP requirements may result in regulatory action. This framework ensures the safety and quality of active ingredients within the UK supply chain.

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## Content

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 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 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. Find out more about the fees we charge at MHRA fees . Make a payment to MHRA

## Attachments

- [flowchart on the registration requirements](https://assets.publishing.service.gov.uk/media/6203d756e90e077f71cd5469/Active_substance_flow_chart_revised_for_2022_edition.pdf)
- [Termination Form ](https://assets.publishing.service.gov.uk/media/6762fee0cdb5e64b69e307fc/Termination_form.docx)