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
31 December 2020 — 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 (also known as a wholesale dealer licence or wholesaler distribution authorisation)
  • manufacturer
  • marketing authorisation (MA)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for issuing wholesale and manufacturer licences. MHRA aim to process all applications within 90 working days.

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

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

You can import an unlicensed medicine if:

  • you import it from a country other than an approved country for import to export it back to a country other than an approved country for import (called an introduced product)
  • you are in Northern Ireland and you import it from a non-EEA country to export it back to a country outside the EEA (called an introduced product);
  • licensed medicines do not work for the special clinical needs of a patient (called a special product)
  • there are no licensed medicines available for the clinical needs of a patient (also called a special product)

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.

Import a special

You’ll need to apply for a:

  • manufacturer ‘specials’ licence if you’re importing medicine from a country other than an approved country for import or if you are in Northern Ireland from outside the EEA (you will need to supply supporting documents)
  • wholesaler licence if you’re importing a medicine from a country on an approved country for import list

You’ll also need to make a notification of intent to import an unlicensed medicine 28 days before you import it.

Make a notification of intent to import an unlicensed medicine

You must send a completed notification of intent form to MHRA.

Each entry must have the unique reference number you have given it and each unlicensed human medicine must be given a product code. This should define:

  • generic name (of drug substance(s))
  • brand name, strength, pharmaceutical form and pack size (for a single pack, as number of items in pack)
  • manufacturer name and address
  • exporting country

The code must be less than 16 characters in length, including spaces and contain only letters and numbers.

Send completed notifications to: imports@mhra.gov.uk.

MHRA may object to the import if:

  • there are concerns about the product’s safety or quality
  • there is an equivalent licensed product available that will meet the special clinical needs of the individual patient
  • there isn’t a special clinical need for a patient to have the product

You can import the product if MHRA does not object within 28 days of their acknowledgement letter.

Importers are responsible for ensuring that the products imported comply with the Transmissible Spongiform Encephalopathies (TSE) Regulations.

Importers should look at the guidance on the TSE requirements when importing an unlicensed medicine.

Make an urgent import notification

In cases of a clinical emergency (usually for life-threatening illnesses or where imminent serious injury is likely) MHRA is able to waive the need for the 28-day notice period and usually process the notification within one working day.

Commercial or other non-clinical reasons are not acceptable reasons for urgency.

During office hours you can talk to the import notifications supervisor by calling 020 3080 7002. If the line is busy, phone 020 3080 6000.

For exceptionally urgent cases that are out of office hours, contact the MHRA duty officer on 07795 641532.

Unlicensed Medicines the MHRA would normally object to import

There are some products that MHRA do not licence for import. Download information relating to specific products (MS Word Document, 325 KB) for updates on importing:

  • cisapride
  • melatonin
  • single component measles, mumps and rubella vaccines
  • subcutaneous immunotherapy (allergy desensitising products)
  • sublingual immunotherapy (SLIT) products
  • supplements from the USA
  • talc preparations for pleurodesis

Supply of unlicensed medicines between Northern Ireland and Great Britain

Once imported into the United Kingdom or manufactured in the United Kingdom, unlicensed medicines may be supplied between Northern Ireland and Great Britain (England, Wales and Scotland) without making additional notifications to MHRA.

The supplier in either territory may supply the unlicensed human medicine to a person authorised to receive a medicine (such as a doctor or a hospital), or to a wholesaler in the receiving territory.

The supplier will need to confirm that there is a special clinical need for use of the medicine which is unlicensed in the receiving territory.

Fees

Fees are charged annually using a banding system based on the number of notifications you submit. Customers are provided with an estimate early in the financial year, followed by an invoice once all the information for the year is available.

A doctor may make the request to a licensed importer, or to a pharmacist who then places the order with the importer. If a doctor or pharmacist holds their own wholesaler or specials licence, they can make the order themselves.

Fees for safety and quality vetting of unlicensed imported medicines

Number of notifications estimated for coming year Additional sum to be paid with annual periodic fee for manufacturers licence holders and wholesale dealer licence holders £
1-20 130
21-100 519
101-1,000 2,077
1,001-5,000 10,383
5,001-20,000 25,957
20,001-50,000 51,914
50,001-100,000 103,828
100,001+ 155,742

Combination medicines and products, which have two different medicines within one pack, are considered a single notification. Separate packs of different products would require separate notifications.

Contact

For help, email imports@mhra.gov.uk or phone 020 3080 7002.

Published 9 August 2005
Last updated 31 December 2020 + show all updates

  1. 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.

  2. New information around Northern Ireland has been added

  3. First published.

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've 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