Reino Unido #6499 (v.6)

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 9 October 2023 and available on
gov.uk at:
https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk.

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 currently in shortage or risk of being in shortage;
- The export of the medicine would contribute to or exacerbate a shortage, or risk of 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 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.

HS 2022