Guidance

Import a human medicine

The licences you need to import medicines and what to do if a medicine is unlicensed.

Overview

You’ll need to hold a wholesaler licence (also known as a wholesale dealer licence or a wholesaler distribution authorisation) if you want to:

  • import from the European Economic Area (EEA) and supply in the UK or EEA
  • import from a non-EE country and export to a non-EEA country

You need a manufacturer licence that authorises import if you want to import from outside the EEA and supply a country within the EEA.

These licences are issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

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

If you are not the marketing authorisation (MA) holder for the product you are sourcing and have not been asked by the MA holder to source the product you must tell the MA holder.

If the product has an MA issued by the European Medicines Agency (EMA) you will need to inform the EMA as well.

Human medicines imported from outside the EEA must be manufactured in accordance with EU good manufacturing practices (GMP) or to equivalent standards. Manufacturing sites are inspected when there is a new marketing authorisation application where the applicant uses the site.

Import unlicensed medicines

In certain circumstances a human medicine that is unlicensed in the UK can be imported and used to meet the special clinical needs of a patient that cannot be met by a licensed medicine.

To import an unlicensed human medicine from outside of the EEA, you need a manufacturer ‘specials’ licence.

To import an unlicensed human medicinal product from within the EEA, you need a wholesaler licence (also known as a wholesale dealer licence or a wholesaler distribution authorisation).

These licences must be valid for import and handling unlicensed medicinal products.

See MHRA guidance on importation in chapter 5 of supply unlicensed medicinal products (‘specials’).

You can also see quarterly reports on the import of unlicensed medicines for more information.

Notification of intent to import an unlicensed medicine

You must send MHRA a completed notification of intent form 28 days before you import the product.

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.gsi.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

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

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

Importers should refer to the guidance on the TSE requirements when importing an unlicensed medicine.

Urgent import notifications

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 on 020 3080 7002, however if the line is busy telephone 020 3080 6000.

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

Import information for specific products

See our information relating to specific products (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 early estimate in the financial year, followed by an invoice once all the information for the year is available.

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

Contact

Email: imports@mhra.gsi.gov.uk, telephone: 020 3080 7002