Royaume-Uni #6499 (v.2)

Measures to regulate exports of certain medicaments.

Regulation 43(2) of the Human Medicines Regulations 2012 requiring wholesale dealers to ensure continued supply of medicinal products so that the needs of patients in the UK are met. Further details can be found through: https://www.legislation.gov.uk/uksi/2012/1916/contents/made

The date restrictions came into effect varies by medicine; this is specified for each medicine on the list, updated on 16 December 2021 and available on gov.uk at
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042790/restricted-medicines-list-december-2021-v3.csv/preview

The list of medicines is maintained by the Department of Health and Social Care.

These measures are reviewed regularly.
A full change log of previous measures, from October 2019, can be found here:
https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk

Medicines included on this list meet the following conditions:
• 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 the medicine is either contributing to, or may contribute to, a shortage of that medicine in the UK.

Medicines on this list which have been produced to fulfil contracts overseas are not subject to
restriction. As such, restrictions only apply to wholesaler dealer license holders that are not the market authorisation holder for a medicine intended for export. The measures are designed to ensure wholesalers fulfil their legal obligations to maintain supply to UK patients.
These restrictions are only applied and maintained where
alternative measures are not considered sufficient on their own to ensure that UK supply meets demand.
A number of exemptions apply to medicines in scope of these restrictions. For example, exports destined for international humanitarian organisations such as COVAX are not covered. A full list of exemptions can be found at https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk

Requests for exemptions are considered on a case-
by-case basis. These can be submitted by a foreign government or government agency, or a wholesaler on their behalf at restrictedmedicines@dhsc.gov.uk

Further information on these measures is available here: https://www.gov.uk/guidance/parallel-export-and-hoarding-of-restricted-medicines

It is the responsibility of the wholesaler to ensure any exports are made or withheld in compliance with these restrictions. Failure to comply with these restrictions may lead to regulatory action by the Medicines and Healthcare products Regulatory Authority (MHRA) against the

wholesale dealer’s licence.
There are no additional steps or declarations required from a customs perspective.

HS 2017