How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

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 go to the Eudra GMDP website to view the lists of:

Apply for a manufacturer/importer licence

How to apply

Complete the application form for a manufacturer’s licence.

Email your form and the required accompanying documents to pcl@mhra.gsi.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

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 dealer’s licence.

How to apply

Use the 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 postmaster@vmd.defra.gsi.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/ importer’s 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 site master plan.

Shortly after the inspection you will receive a report, with details of any issues raised. When the inspector is satisfied that these issues have been addressed, MHRA will grant your registration and you will receive:

  • a licence document
  • a manufacturer’s certificate of good manufacturing practice (GMP) for each inspected site
  • for wholesale distributors, a certificate of good distribution practice (GDP) for each inspected site

This information is available on the EUDRAGMDP database of the European Medicines Agency website.

Applicants can find important information to assist them in the process of applying and holding a licence on our Inspectorate blog.

Make a change to a licence (variation)

You must tell MHRA if the details of your original manufacturer or wholesaler licence application change. The 2 types of changes are called standard and administration changes (also known as variations).

Standard variations include changes to:

  • the business process
  • the named person(s)
  • the site address

A standard variation may require an inspection and you may have to pay an inspection fee as well as the variation fee.

See variation forms for manufacturer licences.

See wholesaler licences variations

Administrative variations include changes to:

  • telephone numbers and email addresses
  • contact persons
  • the company name
  • the additions or deletions of listed products on the manufacturer licence

Making identical changes to a number of licences

If you need to make exactly the same change(s) to a number of different licences (with the same licence number), the licence that has the higher fee will be charged at the full rate and the remaining licences at 50%.

Requesting multiple changes at the same time

We only charge per submission and not per change so if you make a number of changes you will only have to make a single payment for the change which attracts the higher fee.

Change of ownership

You must apply for a change of ownership when a sole trader becomes a limited company and the new company continues manufacturing or wholesale distributing a medicinal product. Use the Portal to register the new company and submit a new application, clearly stating change of ownership from company A to company B, once this has been processed the old WDA(H) Authorisation will be terminated.

When completing the new application, only the company name, name of the licence holder and site name may change, to make any other changes you must apply for a variation after the new application has been approved.

Withdraw your licence application

You can withdraw your application at any point but you may not get all of your money back.

For manufacturer licences, if you withdraw your application before the inspection, 90% will be refunded. If the inspection has taken place, 50% will be refunded.

For wholesaler licences, you pay the full fee, unless you withdraw the application at least 15 days before the inspection.

Terminate a licence

To request termination of licence you should complete the the Request to terminate a licence/ authorisation/ registration (MS Word Document, 334KB) and email it to pcl@mhra.gsi.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 annual charge for maintaining your licence is payable on invoice in April of each year.

The fee payable depends on the type of application, the number of sites, and how much income you make from the wholesale of licensed medicines.

Type of fee Wholesaler licences Manufacturer licences Non-orthodox practitioners
Full application fee £1803 £3143 £183
Reduced application £902 n/a n/a
Standard inspection (per site) £1936 £2655 £295
Standard herbal/homeopathic inspection fee (per site) £1367 £1615 n/a
Reduced rate inspection £968 n/a n/a
Reduced rate herbal/homeopathic inspection £744 £994 n/a
Standard variation £486 £514 £257
Administrative variation £257 £257 n/a
Change of ownership £398 £344 n/a
Renewal n/a n/a £178 (every 5 years)
Annual service fees £303, £181 (reduced) £493 n/a

Reduced fees apply for wholesale distributors if:

  • you are applying for a wholesaler licence to sell GSL medicines only
  • you are a registered pharmacy and the wholesale of medicines amounts to less than 15% of your total turnover in licensed medicinal products
  • you are not a registered pharmacy and you make less than £35,000 a year from licensed medicinal products

Full guidance is available on all MHRA fees.

Make a payment to MHRA.

Contact

Email: pcl@mhra.gsi.gov.uk
Telephone: 020 3080 6844

PCL Enquiries
5th Floor
151 Buckingham Palace Road
London
SW1W 9SZ