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.

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 in the European Economic Area (EEA) and then supply it to another country, including the UK
  • a non-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 how much money you make from sales.

Apply for a wholesaler licence

Apply for a manufacturer licence

You’ll need to apply for a manufacturer licence if you import medicine from outside the EEA or 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:

Apply for an MA licence

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 EU’s EudraGMDP website.

Import an unlicensed medicine

You can import an unlicensed medicine if:

  • you import it from outside the EEA 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)

Import an introduced product

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

You can only export an introduced product to a person authorised in 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 another EEA country.

Import a special product

You’ll need to apply for a:

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 should have the short product code.

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 clinical emergency (usually the treatment of life-threatening illness or where significant injury is likely) MHRA is able to process an import notification within one working day.

Commercial or other non-clinical reasons aren’t 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.

Products the MHRA will not licence for import

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

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

    There are several tasks you need to do before you can get goods through customs.

    1. Check the whole process for importing goods from countries outside the EU

    Most businesses that import goods hire a transporter or customs agent to make the import declaration and clear their goods through UK customs.

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

    The business importing the goods and any transporter or customs agent acting on their behalf both need an EORI number.

    1. Get an EORI number

    You'll use the Customs Handling of Import and Export Freight (CHIEF) system to make a declaration. You'll need to both:

    You can apply for simplified declaration procedures and for Authorised Economic Operator status. These are most suitable for businesses that import goods regularly.

    1. Find out about using simplified declaration procedures
    2. Check if Authorised Economic Operator status is right for you
  3. and Register to import goods with restrictions

  4. Step 3 Set up a duty deferment account if you import regularly

    Set up a duty deferment account if you want to be able to make one payment of customs duties a month instead of paying for individual shipments.

    You must set one up if you use simplified procedures.

    1. Set up a duty deferment account
  5. Step 4 Arrange for the goods to be inspected

    You need to choose a place where the goods can be inspected if you import things like plant or animal products. 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.

    1. Find out what rules you need to follow to get the goods inspected
  6. Step 5 Submit the import declaration

  7. Step 6 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
  8. Step 7 Get the goods released if they're held up at the border

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

    • 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