United Kingdom #6499 (v.8)

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 and available on gov.uk at:
https://assets.publishing.service.gov.uk/media/676550c8cdb5e64b69e30924/restricted-medicine-list-20-december-2024.csv/preview

The list of medicines is maintained by the Department of Health & Social Care.
 
These measures are reviewed regularly, and changes are notified in amendments to this measure.

A full change log of previous measures, from October 2019, can be found here under ‘See all updates’:
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 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

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.

1. The UK is notifying the removal of 19 medicines from the list in critical short supply which are currently subject to export restrictions. These medicines no longer meet the tests set to maintain these measures. These are: Amiodarone, Azithromycin, Aztreonam, Bumetanide, Bupivacaine + Fentanyl, Carbamazepine, Dexamethasone, Heparin, Levomepromazine, Linezolid, Midazolam, Oxycodone, Paracetamol, Permethrin, Prochlorperazine, Quetiapine, Salbutamol, Sodium dihydrogen phosphate anhydrous, and Vinblastine.

2. The UK is also notifying the addition of 2 medicines to the list in critical short supply.

3. Insulin isophane human 100units/ml cartridges (3004.31.00) are used in the treatment of diabetes mellitus. They were restricted for export on 20 December 2024 following the supplier discontinuing the product globally. There are currently no alternative medicines that can meet the demand for Insulatard.

4. Folinic acid (3004.90.00) is used in the treatment of methotrexate toxicity, a chemotherapy drug used to treat various cancers and autoimmune diseases, and for enhancing the effectiveness of 5-fluorouracil in cancer treatment. It was restricted for export on 1 October 2024 due to manufacturing capacity constraints and inability to meet ongoing demand. The UK is also engaging with all Marketing Authorisation Holders to identify any additional stock.

5. These are temporary measures, in place to relieve critical shortages of medicines necessary for the protection of human health. Restrictions are only applied when critical need cannot be met by alternative measures alone. Measures are reviewed every 6 months, with products removed from the list if there is no longer a critical need. We expect the next review to take place in Spring 2025.

HS 2022

G/MA/QR/N/GBR/3/Add.1