Guide to Manufacturer and Wholesaler Licences for Medicines in the UK

1. Overview

1.1 Manufacturer’s Licence

To manufacture, assemble, or import human medicines, a manufacturer’s licence is required, issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Compliance with EU good manufacturing practice (GMP) and passing regular GMP inspections are necessary. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

1.2 Wholesale Distribution Licence

For selling or supplying medicines to anyone other than the patient, a wholesale distribution licence is needed, complying with good distribution practice (GDP) and passing regular GDP inspections. Authorised manufacturers and wholesalers can be viewed on the MHRA GMDP website or Eudra GMDP for pre-2021 licences. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

2. Applying for a Manufacturer’s/Importer’s Licence

2.1 Application Process

Refer to Guidance Note 5 for applicants and holders of a manufacturer’s licence. Complete the application form and email to pcl@mhra.gov.uk. Fees are payable upon invoicing. The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) provides additional information. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

2.2 Types of Manufacturer’s Licences

Different licences apply based on the products:

• Manufacturer’s/importer’s licence: For licensed medicinal products, including import from outside the EEA.
• Manufacturer’s ‘specials’ licence: For unlicensed ‘specials’ and imports from outside the EEA.
• Manufacturer’s licence for investigational medicinal products: For clinical trial products.
• Manufacturer’s licence exempt advanced therapy products: For non-routine advanced therapy products in UK hospitals.
• Manufacturer’s licence for non-orthodox practitioners: For mixing and assembling GSL products. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences Companies applying for marketing authorisation must have a manufacturer’s licence first. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

3. Applying for a Wholesale Distribution Licence

3.1 Requirements

A licence is required for selling or supplying medicines wholesale, importing from the EEA, or exporting to the EEA. It covers pharmacy, prescription only, traditional herbal, and GSL medicines. Refer to Guidance Note 6 for applicants and holders. The Rules and Guidance for Pharmaceutical Distributors (The Green Guide) provides more details. Pharmacists need a licence for supplies other than to the public, with limited exemptions. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

3.2 Application Process

Apply via the Process Licensing (PCL) portal. Fees are required for processing. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

4. Veterinary Licences

MHRA administers licences for companies handling both human and veterinary products. For veterinary-only, contact the Veterinary Medicines Directorate. Complete the veterinary manufacturer’s licence form. Types include manufacturer’s/importer’s authorisation and ‘specials’ authorisation. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

5. Application and Inspection Process

Applications are assessed in 90 working days; variations in 30-90 days if inspection needed. MHRA may verify identities and company details. Provide a site master plan for manufacturing sites. Post-inspection report addresses issues; upon resolution, receive licence, GMP/GDP certificates on EudraGMP database. Inspectorate blog offers additional information. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

6. Changes to a Licence (Variations)

Notify MHRA of changes: standard (e.g., business process, named persons, site address) may require inspection and fees; administrative (e.g., contact details, company name). For identical changes across licences, reduced fees apply. Multiple changes charged at highest fee rate. For change of ownership, register new company and apply via portal or forms. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

7. Withdrawing or Terminating a Licence

Withdrawals may refund fees partially. Terminate via form emailed to pcl@mhra.gov.uk, no fee, but request before 31 December to avoid annual fees. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

8. Checking Status

Use RegulatoryConnect to check application and licence status. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

9. Fees and Payment

Annual maintenance fees invoiced in April. Fees vary by application type, sites, and income. See MHRA fees. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

10. Contact Information

Email: pcl@mhra.gov.uk. Address: PCL Enquiries, MHRA, 10 South Colonnade, London E14 4PU. For Distance Selling Logo: dsl@mhra.gov.uk. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

11. Publication and Updates

Published 18 December 2014, last updated 12 September 2025. Updates include changes to ownership info, removal of licence types, addition of RegulatoryConnect, fee updates, and more. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences