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Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
August 15, 2025
Approximately 5 minutes
Medicines: Register to Manufacture, Import or Distribute Active Substances in the UK
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
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