Medicines Healthcare Products Regulatory Agency
Overview
Manufacturer licence
To make, assemble or import human medicines, you need a manufacturer licence, issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).
To qualify for a manufacturer licence you need to show MHRA that you comply with EU good manufacturing practice (GMP) and pass regular GMP inspections of your site.
Wholesaler licence
To sell or supply medicines to anyone other than the patient using the medicine, you need a wholesaler licence also known as a wholesale dealer licence or wholesale distribution authorisation.
To qualify for a wholesale licence, you must comply with good distribution practice (GDP) and pass regular GDP inspections of your site.
You can view authorised manufacturers of medicines and authorised wholesalers of medicines by visiting the MHRA GMDP website or for licences issued prior to 1st January 2021 visit the Eudra GMDP website.
Apply for a manufacturer/importer licence
How to apply
Complete the application form for a manufacturers licence.
Email your form and the required accompanying documents to pcl@mhra.gov.uk.
Fees for new applications will be payable on invoice.
See guidance note 5, which contains notes for applicants and holders of a manufacturer licence.
You can refer to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) available on the Pharmaceutical Press website for more information.
Types of manufacturer licence
There are different manufacturer licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products.
| Type of licence | Purpose |
|---|---|
| Manufacturer/importer licence | Manufacture and/or assemble licensed medicinal products, including export to a country outside the EEA Import licensed medicinal products from countries outside the EEA |
| Manufacturer specials licence | Manufacture unlicensed medicines specials Import unlicensed medicinal products from outside the EEA |
| Manufacturer licence for investigational medicinal products | Manufacture investigational medicinal products for use in clinical trials |
| Manufacturer licence exempt advanced therapy products (Hospital exemption licence) | Manufacture exempt advanced therapy medicinal products on a non-routine basis for use in UK hospitals |
| Manufacturer licence for non-orthodox practitioners | Mix and assemble licensed general sales list (GSL) medicinal products |
Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.
Apply for a wholesale dealer licence (wholesale distribution authorisation)
Individuals or companies that sell or supply human medicines to anyone other than the patient must have a wholesale dealer licence.
You must also hold this licence if you sell on medicines that you have imported from the EEA.
The wholesale dealer licence allows you to:
- sell, supply, offer for sale or supply pharmacy, prescription only, traditional herbal and GSL medicines wholesale
- import unlicensed medicinal products from countries inside the EEA
- export medicinal products to countries of EEA
See guidance note 6, which contains notes for applicants and holders of a wholesale dealer license or broker registration.
You can refer to the Rules and Guidance for Pharmaceutical Distributors (The Green Guide) available on the Pharmaceutical Press website for more information.
Pharmacists need to apply for a wholesale dealer licence if they want to supply medicines to anyone other than directly to the public. See guidance on the limited circumstances where supply may be made without a wholesale dealers licence.
How to apply
Use the PCL portal.
You must pay the fee for a new application for the wholesale distribution authorisation to be processed.
Veterinary licences
MHRA have an agreement with the Veterinary Medicines Directorate to administer those licences only where the company undertakes both human and veterinary activities.
If your company only undertakes the manufacture or wholesale of veterinary products you need to contact inspections@vmd.gov.uk for further information.
Complete the application form for a manufacturer or wholesale dealer licence for veterinary products.
You can find further information in the veterinary medicines guidance notes
Types of veterinary licence
There are different manufacturer licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products.
| Type of licence | Purpose |
|---|---|
| Manufacturer/ importers authorisation | Manufacture and/or assemble (package) veterinary medicinal products Wholesale deal licensed veterinary medicinal products imported from countries outside EEA |
| Manufacturer specials authorisation | Allows the holder to manufacture unlicensed veterinary medicinal products (commonly referred to as specials) |
| Wholesale dealer authorisation | Allows the holder to wholesale deal veterinary medicines (POM-V, POM-VPS, NFA-VPS, AVM-GSL) |
| Import of unlicensed veterinary medicinal products from inside the EEA |
Application process (for all applications)
Your application will be assessed by MHRA and should take 90 working days to process.
Variations to licences should take 30 working days to process. This will be extended to 90 working days if the variation requires an inspection.
MHRA may:
- check the identities of the responsible person and named staff
- check a named company with Companies House
Inspection process (for all applications and variations)
The inspection process is similar to that for good manufacturing practice.
For manufacturing sites you will have to provide a