Guidance

Import a human medicine

Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.

From:
Medicines and Healthcare products Regulatory Agency and Department of Health and Social Care
Published
9 August 2005
Last updated
29 January 2025 — See all updates

Import a licensed medicine

If you want to import a licensed medicine you’ll need to apply for one or more licences:

  • Wholesale distribution licence (WDA(H))
  • Manufacturer’s licence
  • Marketing authorisation, also known as product licence (MA)

If the human medicine you want to import contains a controlled substance (having or using it is controlled by law) you must contact the Home Office.

Apply for a wholesaler licence (WDA(H))

You’ll need to apply for a wholesaler licence if you import medicine from:

  • a country on an approved country for import list or if you are in Northern Ireland a country in the European Economic Area (EEA) and then supply it to another country, including the UK
  • a country other than an approved country for import and export it to a country other than an approved country for import or if you are in Northern Ireland a EEA country and export it to a non-EEA country

How much you pay depends on the type of application, the number of sites, and your total turnover in licensed human medicines.

If your company is based in Great Britain, you may need a Responsible Person for Import.

Apply for a wholesaler licence

Apply for a manufacturer licence

You’ll need to apply for a manufacturer licence if you import medicine from a country other than an approved country for import for use in the UK or to supply it to a country on an approved country for import list.

If you are in Northern Ireland you’ll need to apply for a manufacturer licence if you import medicine from outside the EEA for use in the UK or to supply it to an EEA country.

Apply for a manufacturer licence

Apply for a marketing authorisation (MA) licence

You need to have an MA licence before you can sell a human medicine. There are many types of MA licence so the process you need to follow depends on the type of MA licence you need.

Before a medicine can be released to the market, a Qualified Person (QP) named in the manufacturer/importer licence must certify that it has been manufactured and tested according to:

Site inspections

MHRA will inspect the manufacturing site you use to produce or import the medicine when you’re applying for an MA.

There is a list of GMP-compliant manufacturers available on the MHRA-GMDP or for certificates issued prior to 1st January 2021 on the EUDRAGMDP website.

There is a list of GMP-compliant manufacturers available on MHRA-GMDP.

Apply for an MA licence

Import an unlicensed medicine

If you want to import an unlicensed medicine into the UK you will need:

Before you import an unlicensed medicine you will need to notify the MHRA of your intent to import an unlicensed medicine before you import it. You can only proceed with the import if the MHRA does not object to it.

Additional information on the importation and supply of unlicensed medicines can be found on Supply unlicensed medicinal products (specials)

Import an introduced product

You must be a licensed wholesale dealer in the UK to import an introduced product.

You may only obtain an introduced medicine from a person authorised in the country other than an approved country for import or if you are in Northern Ireland in the non-EEA country to supply medicinal products by wholesale distribution.

You can only export an introduced product to a person authorised in the country other than an approved country for import or if you are in Northern Ireland the non-EEA country to receive medicinal products for wholesale distribution or supply to the public.

An introduced medicinal product will not have an MA for the UK or a country on an approved country for import list.

Contact

Please refer to Contact the MHRA

Updates to this page

Published 9 August 2005
Last updated 29 January 2025 show all updates

  1. Updated to reflect current guidance on the importation of medicines. Details on the importation of unlicensed medicines were moved to a new, dedicated page.

  2. Added information applying for a wholesaler licence or a manufacturer licence, the process for importing an unlicensed medicine and importing a special. This follows the end of the transition period.

  3. New information around Northern Ireland has been added

  4. First published.

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Contents

Part of Get UK customs clearance when importing goods into the UK: step by step

  1. Step 1 Check if you need to follow this process

    Follow these steps to get your goods for import through UK customs if you’re managing the process yourself.

    Getting customs clearance is complicated. You can hire a transporter or customs agent to make the import declaration and get your goods through UK customs.

    1. Hire someone to deal with customs for you

    Your business must be ready to import the goods before you can get customs clearance.

    1. Find out about importing goods into the UK
    1. Check if you need to make an import declaration

  2. Step 2 Set up your business for making import declarations

    You need an EORI number that starts with GB to import goods into England, Wales or Scotland. You'll need a new one if you have an EORI that does not start with GB.

    If you move goods to or from Northern Ireland you may need one that starts with XI.

    1. Get an EORI number

    Depending on where you're moving goods, you need to be registered on the right systems and have compatible software to make declarations.

    1. Check what systems and software you need to make declarations

  3. Step 3 Check if you can make the customs process quicker

    There are processes that can make clearing customs quicker and easier to manage if you have to make import declarations regularly.

    1. Find out about using simplified declaration procedures
    2. Check if Authorised Economic Operator status is right for you

    If you're importing goods from the EU to England, Scotland or Wales (Great Britain) you might be able to delay making a declaration for up to 6 months.

    1. Check if you can declare your goods later if you're importing goods from the EU

    If you regularly import goods using Common Transit, you can apply to start movements of goods at your own premises.

    1. Check if consignee status is right for your business

  4. Step 4 Register to import goods with restrictions

    You need to register as an importer if you import things like plant or animal products, high-risk food or feed, medicines, textiles, chemicals or firearms.

    Register to import:

  5. Step 5 Check if you need a licence or certificate for your goods

    There are special rules and you may need to get licences or certificates if you are importing any of the following:

  6. and Check the labelling, marking and marketing rules

    1. Check the marking, labelling and marketing standards for food, plant seeds and manufactured goods

  7. Step 6 Arrange for the goods to be inspected

    If you import things like plant or animal products, you need to choose a place where the goods can be inspected. This needs to happen before they’re allowed through the UK border.

    1. Find an inspection point for animals and animal products
    2. Find an inspection point for plants, plant products, seeds and wood
    3. Find an inspection point for high risk food and feed that is not of animal origin
    4. Find an inspection point for endangered species, or products made from endangered plants or animals

    You need to let the inspection point know when the goods are arriving. You might have to pay a fee for the inspection.

  8. Step 7 Submit and manage the import declaration

    1. Find out how to submit import declarations
    2. Find out how to change or cancel an import declaration

    If you're importing goods from the EU to England, Scotland or Wales (Great Britain) you might be able to delay making a declaration for up to 6 months.

    1. Check if you can declare your goods later to make the importing process quicker

  9. Step 8 Pay VAT and duty

    HMRC will tell you how much to pay after you submit the declaration.

    1. Find out how and when to pay VAT and duty

  10. Step 9 Get the goods released if they're held up at the border

    The goods may be held at the border if, for example:

    • you have not paid the right amount of duty or VAT
    • you do not have the right import licences for the goods or business
    • they did not pass inspection
    • they have been combined with a shipment that has been held up

    If this happens you will be told why.

    1. Contact the National Clearance Hub to get help

Also part of