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: [email protected].

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 [email protected] or phone 020 3080 7002.

Updates to this page

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.

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Contents

Part of Import goods into the UK: step by step

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

    Follow these steps if you're moving goods permanently to:

    • England, Wales or Scotland (Great Britain) from a country outside the UK
    • Northern Ireland from a country outside the UK and the EU

    What you need to do is different if you are:

  2. Step 2 Get your business ready to import

    You need an Economic Operators Registration and Identification number (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 number 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

    If you store goods in the UK for sellers outside the UK, you may need to apply to the Fulfilment House Due Diligence Scheme.

    1. Find out if you need to apply to the Fulfilment House Due Diligence Scheme

    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

  3. and Check the business sending you the goods can export to the UK

    The business sending you the goods may need:

    • to make an export declaration in their country
    • licences or certificates to send goods to the UK

    Check whoever is sending the goods is able to export them from their country.

  4. Step 3 Decide who will make customs declarations and transport the goods

    You can hire someone to deal with customs and transport the goods for you, or you can do it yourself.

    Most businesses that import goods use a transporter or customs agent.

    1. Find out how to hire someone to deal with customs for you

  5. Step 4 Find out the commodity code for your goods

    You’ll need to include the commodity code on your import declaration. This will determine the rate of duty you need to pay and if you need an import licence.

    Your customs agent or transporter might be able to help you with this.

    1. Find the right commodity code for your goods

  6. and Work out the value of your goods

    When you make your import declaration, you’ll need to include the value of your goods - this helps work out how much duty and VAT you’ll need to pay.

    1. Work out the value of your goods for customs

  7. Step 5 Find out if you can reduce your Customs Duty

    You may be able to pay less or no Customs Duty if the UK has a trade agreement with the country you're importing from.

    1. Find out if you can pay a lower rate of Customs Duty because of a trade agreement

    You may also be able to reduce the amount of duty you pay based on what the goods are and what you plan to do with them.

    1. Check other ways you can pay a lower rate of Customs Duty

  8. and Find out if you can delay your Customs Duty

    You may be able to delay sending information about goods or paying Customs Duty.

    1. Check if you can delay your Customs Duty

  9. Step 6 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:

  10. Step 7 Check the labelling, marking and marketing rules

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

  11. Step 8 Get your goods through customs

    If you've appointed someone to deal with UK customs for you, they'll make the declaration and get your goods through the UK border.

    1. Make an import declaration yourself and get your goods cleared by UK customs

  12. Step 9 Claim a VAT refund

    If you're VAT registered, you can claim back any VAT you paid on the goods you've imported. You’ll need your Import VAT Certificate (C79).

    1. Find out how to claim a VAT refund

  13. Step 10 If you paid the wrong amount of duty or rejected the goods

    If you paid too much Customs Duty or import VAT or rejected the goods, you can claim a refund or ask for a payment to be waived.

    1. Find out how to claim a refund or make a claim for rejected imports

    If you paid too little Customs Duty or import VAT, report it to HMRC.

    1. Find out how to tell HMRC you’ve underpaid and pay the difference

  14. Step 11 Keep invoices and records

    You must keep records of commercial invoices and any customs paperwork, including your Import VAT Certificate (C79).

    If you imported controlled goods, for example firearms, keep any paperwork that shows who owns them.

Also part of