Guidance

Export and hoarding of restricted medicines

Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.

The government has restricted the export and hoarding of some medicines.

The restrictions apply to the exporting of medicines placed on the market in the UK for UK patients.

Hoarding of medicines is when wholesale dealers withhold a medicine when it’s in short supply.

Exporting and hoarding of medicines can create or worsen medicine shortages.

This guidance will still apply once the transition period has ended.

The restricted medicines list is reviewed and updated regularly. It is your responsibility to check it before exporting medicines.

From 1 January 2021 you may no longer be able to export branded medicines that have been placed on the UK market to countries in the European Economic Area (EEA).

Check the guidance on changes to the exhaustion of Intellectual Property rights and parallel trade from 1 January 2021.

Medicines you cannot export or hoard

See the list of medicines that you cannot export from the UK or hoard because they’re needed to meet the needs of UK patients.

This list is reviewed and updated regularly. It’s your responsibility to check this list before exporting medicines.

The restrictions apply to exports to all countries in or outside the EEA.

Sign up to receive an email alert when the list is updated.

Exporting to countries in or outside the EEA

You cannot export medicines on the restricted medicines list that have been put on the market for UK patients to other countries in or outside the EEA.

As of 1 January 2021 you may no longer be able to export branded medicines that have been placed on the UK market to countries in the EEA.

Check the guidance on changes to the exhaustion of Intellectual Property rights and parallel trade from 1 January 2021.

Exporting medicines for which you hold a marketing authorisation

You can continue to export medicines on the restricted medicines list if you, or a company in your group of companies, holds a marketing authorisation for those medicines. The restrictions do not apply.

Exporting UK licensed medicines that are unlicensed in the destination country

You cannot export medicines on the restricted medicines list that have been put on the market for UK patients, whether they are licensed or unlicensed in the destination country.

Exporting medicines that are licensed under article 126a in the destination country

You can continue to export medicines on the restricted medicines list that are licensed under article 126a of Directive 2001/83/EC in the destination country. The restrictions do not apply.

Exporting medicines meant for markets abroad

You can continue to export medicines on the restricted medicines list that are manufactured and intended for markets abroad. The restrictions do not apply.

This includes medicines in packaging and labelled for markets abroad but may also include medicines in UK packaging with UK labelling if they were manufactured and intended for other markets and the supply has been part of the forecast of the marketing authorisation holder.

Exporting medicines to ships, planes, the armed forces and British citizens abroad

You can continue to export medicines on the restricted medicines list to:

  • ships
  • planes
  • the British, UN and NATO armed forces
  • British citizens abroad

The restrictions do not apply.

Exporting to crown dependencies and overseas territories

You can continue to export medicines on the restricted medicines list to the crown dependencies and overseas territories. The restrictions do not apply.

Exporting medicines for use by international humanitarian organisations

You can continue to export medicines on the restricted medicines list for use by international humanitarian organisations. The restrictions do not apply.

Exporting medicines for clinical trials and other research purposes

You can continue to export medicines on the restricted medicines list for use in clinical trials and for other research purposes. The restrictions do not apply.

Exports that have already been agreed

If you receive a final agreed purchase order from an importer before the date of restriction then you can still carry out that order. Open, rolling or frame orders placed by importers before the date of restriction can only be fulfilled if the products have been picked and packed, and transport booked.

The restriction for each medicine applies from 00:00am at the start of the date of restriction.

The restricted medicines list includes the date of restriction.

Withholding medicines as part of stock management or stockpiling arrangements

You can continue to withhold medicines as part of stock management arrangements agreed with marketing authorisation holders. It is not considered hoarding.

You can also continue to maintain contingency stockpiles built up at the request of the Department of Health and Social Care (DHSC) or Public Health England (PHE).

Breaching the restrictions

If you export, start hoarding or continue hoarding a medicine on the restricted list it will be considered a breach of regulation 43(2) the Human Medicines Regulations 2012.

It may lead to regulatory action by the Medicines and Healthcare products Regulatory Authority (MHRA) against the wholesale dealer’s licence.

This could include:

  • an immediate suspension of the licence or suspension of the supply of certain products under the licence
  • a 28-day notice proposing to vary the licence to restrict or prevent export activity

If you continue to breach the restrictions it will be considered a criminal offence under regulation 34(1), read together with regulation 18(1) of the Human Medicines Regulations 2012.

How we decide which medicines to restrict

DHSC will prohibit the export of a medicine if it considers that the following conditions are met:

  • the medicine is required to meet the needs of UK patients
  • the medicine is either being exported or is at threat of being exported
  • the export of that medicine is either contributing to, or may contribute to, a shortage of that medicine in the UK

How medicines are listed

Most medicines are listed by virtual therapeutic moiety (VTM) and the list indicates which strengths and pharmaceutical forms the restrictions apply to. If no VTM is available, the medicines are listed by actual medicinal product (AMP).

See which products are covered by a VTM in the Dictionary of Medicines and Medical Devices.

If a VTM has one active ingredient, then only medicines containing that active ingredient are covered by the restrictions and not any medicines that contain multiple active ingredients.

Further advice and information

Email parallelexports@dhsc.gov.uk if you have any questions about the restrictions.

Published 7 October 2019
Last updated 22 December 2020 + show all updates
  1. Updates to exporting and hoarding rules after the transition period.

  2. Updated guidance to state that you can continue to export medicines on the restricted medicines list in the following circumstances: if the medicine is licensed under article 126a of Directive 2001/83/EC in the destination country; if you, or a company in your group of companies, holds a marketing authorisation for those medicines; if you are exporting medicines for clinical trials or other research purposes.

  3. Updated page to clarify the rules around exporting and hoarding of medicines put on the UK market for UK patients.

  4. Added further clarification: you can continue to supply medicines to ships, planes, the armed forces and British citizens abroad.

  5. Added information: you can continue to export medicines to ships, the armed forces and British citizens abroad.

  6. Added section about parallel exporting to UK ships. You can continue to export medicines to UK ships – the restrictions do not apply.

  7. The following information has been added: you cannot export medicines on the restricted medicines list that have been put on the market for UK patients, whether they are licensed or unlicensed in the destination country.

  8. A correction has been made to the paragraph 'Parallel exports that have already been agreed'. The restriction for each medicine applies from 00:00am at the start of the date of restriction. This is the day after a medicine has been added to the restricted medicines list and not the same day ('publication date'), as previously stated.

  9. First published.