Medicines: Register to Manufacture, Import or Distribute Active Substances in the UK

Overview

Active substances (often called active pharmaceutical ingredients – APIs) are the components that give medicinal products their therapeutic effect. If you manufacture, import or distribute active substances and your activities are based in the UK, you must register with the Medicines and Healthcare products Regulatory Agency (MHRA). You can complete this registration via the MHRA Process Licensing (PCL) Portal.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

You must also comply with good manufacturing and distribution practice (GMDP) when undertaking these activities.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

The Registration Process

• Submit an application via the MHRA PCL Portal for registration as a manufacturer, importer or distributor.
• New applications are normally processed within 60 working days, excluding time taken to request additional information.
• Variations that do not require an inspection take about 30 working days to process.
• If an inspection is required, the MHRA will arrange a site visit before issuing the registration document.
  Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

Change Your Registration

You must notify the MHRA via the MHRA PCL Portal if the details in your original registration change (for example, changes to your site information or activities). Some changes may require a new inspection and fees.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

Annual Compliance Reports

Registered active substance manufacturers, importers and distributors must complete an annual compliance report. This report is due every year by 30 April and should be submitted via the MHRA PCL Portal.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

Terminate Your Registration

To terminate your registration, you should complete the Termination Form provided on the MHRA guidance page and email it to pcl@mhra.gov.uk. There is no fee for termination, but to avoid paying the next annual fee, the request must be made before 31 December of the preceding year.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK

Fees and Payment

The fee payable for registration varies depending on the number of sites included in your application. Detailed fees are available in the MHRA fee schedule linked from the guidance page.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK