Overview

Manufacturer’s licence

To make, assemble or import human medicines, you need a manufacturer’s licence, issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).

To qualify for a manufacturer’s licence you need to show MHRA that you comply with EU good manufacturing practice (GMP) and pass regular GMP inspections of your site.

Wholesale distribution licence

To sell or supply medicines to anyone other than the patient using the medicine, you need a wholesale distribution licence – also known as a wholesale distribution licence or wholesale distribution authorisation.

To qualify for a wholesale distribution licence, you must comply with good distribution practice (GDP) and pass regular GDP inspections of your site.

You can view authorised manufacturer’s 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’s/importer’s licence

How to apply

Your 592organisation KB,must 26pay pages)fees for any new applications once we send an invoice.

See guidance note 5, which contains notes for applicants and holders of a manufacturer’s licence.

You can refer to the Rules and guidanceGuidance for pharmaceuticalPharmaceutical manufacturersManufacturer’s and distributorsDistributors (The Orange Guide) available on the Pharmaceutical Press website for more information.

Your organisation must pay fees for any new applications once we send an invoice.

Types of manufacturer’s licence

There are different manufacturer’s licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products.

Type of licence	Purpose
Manufacturer’s/importer’s 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’s ‘specials’ licence

Manufacture unlicensed medicines ‘specials’ Import unlicensed medicinal products from outside the EEA

Manufacturer’s licence for investigational medicinal products

Manufacture investigational medicinal products for use in clinical trials

Manufacturer’s 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’s 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’s licence first. The manufacturer’s licence will be granted first providing the product is in the process of being approved.

Apply for a wholesale distribution licence

Individuals or companies that sell or supply human medicines to anyone other than the patient must have a wholesale distribution licence.

You must also hold this licence if you sell on medicines that you have imported from the EEA.

The wholesale distribution 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 Guidanceguidance note 6: notes for applicants and holders of a wholesale dealer’s licence (WDA(H)) or broker registration6 (PDF, 560 KB, 29 pages), which contains notes for applicants and holders of a wholesale dealer license or broker registration.

You can refer to the Rules and guidanceGuidance for pharmaceuticalPharmaceutical distributorsDistributors (The Green Guide) available on the Pharmaceutical Press website for more information.

Pharmacists need to apply for a wholesale distribution 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

Veterinary licences

The MHRA hashave an agreement with the Veterinary Medicines Directorate to administer those manufacturing 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’s licence for veterinary products.

You can find further information in the veterinary medicines guidance collectionnotes

Types of veterinary licence

There are different manufacturer’s licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products.

Type of licence	Purpose
Manufacturer’s/ importer’s authorisation	Manufacture and/or assemble (package) veterinary medicinal products Wholesale deal licensed veterinary medicinal products imported from countries outside EEA
Manufacturer’s ‘specials’ authorisation	Allows the holder to manufacture unlicensed veterinary medicinal products (commonly referred to as ‘specials’)

Application process (for all applications)

Your application will be assessed by the 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.

The MHRA may:

• check the identities of the responsibleResponsible personPerson 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 EudraGMP database of the European Medicines Agency.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 the MHRA if the details of your original manufacturer’s or wholesale distribution 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 persons
• 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’s licences.

See wholesale distribution 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’s 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

YouMultiple canchanges requestmay multiplebe changesrequested in the same variation. 

You will only be charged for the change which attracts the highest fee.

Change of ownership

If you do not hold a manufacturer’s licence or wholesale distribution authorisation, you may apply for a change of ownership of the licence if you buy a company that holds the licence and you wish to continue to conduct the same activities.

If this concerns a wholesaleWholesale dealer’sDealer’s authorisationAuthorisation (WDA(H)), use the MHRA portal to register the new company and submit a new application.  

When completing the application, select Yes to the question Is this a change of ownership application? and provide the WDA(H) licence number for the authorisation you are changing ownership from in the free text box.  

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 be changed. Tochanged. To make any other changes you must apply for a variation after the new application has been approved. The application must include a statement to the effect that the existing licence holder intends to cease the activities to which their licence relates and has consented in writing to the making of the application. A similar statement should be provided by the existing licence holder.approved.

If this concerns a manufacturing licence, you must complete variation forms 1V, 2V and 3V and send in a certificateCertificate of incorporationIncorporation to pcl@mhra.gov.uk.

Withdraw your licence application

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

For manufacturing licences and wholesale distribution authorisations, if you withdraw your application before the inspection, 90% of the application fee will be refunded. If the inspection has taken place, 50% of the application fee will be refunded.

For wholesale distribution authorisations, the full inspection fee will be payable, unless you withdraw the application for the licence at least 15 days before the date on which the inspection is due to take place.

Terminate a licence

To request termination of licence you should complete the TerminationRequest form (MSto Wordterminate Document,a 756licence/authorisation/registration KB) and email it to pcl@mhra.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.

Check the status of your application or licence

You can find and check the status of applications submitted on RegulatoryConnect.

RegulatoryConnect also helps you check the authorisation status of licences that have already been approved.

See further guidance on RegulatoryConnect.

Fees and payment

You will need to pay the annual charge to maintain your licence in April of each year. We will send you an invoice before you need to pay.

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	Wholesale distribution licences	Manufacturer’s licences	Non-orthodox practitioners
Full application fee	£1,983	£3,457	£201
Reduced application	£992	n/a	n/a
Standard inspection (per site)	£2,622	£3651	n/a
Standard herbal/homeopathic inspection fee (per site)	£1,880	n/a	n/a
Reduced rate inspection	£1,331	n/a	n/a
Reduced rate herbal/homeopathic inspection	£1,023	n/a	n/a
Standard variation	£535	£565	£283
Administrative variation	£283	£283	n/a
Change of ownership	£439	£378	n/a
Renewal	n/a	n/a	£196 (every 5 years)
Annual service fees	£317, £189 (reduced)	£515	n/a

SeeSpecial reduced rates to apply to: 

• wholesale dealers handling GSL products only 
• registered retail pharmacies where wholesaling of licensed products does not exceed 15% of total turnover in licensed products 
• small wholesale dealers where wholesaling of licensed products does not exceed £35,000 of total turnover in licensed products

Full guidance is available on all MHRA fees.

Use GOV.UK Pay to make a payment to MHRA.

Contact

Email: pcl@mhra.gov.uk  

For all queries regarding Distance Selling Logo email: dsl@mhra.gov.uk