Reino Unido #6499 (v.7)

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/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 & 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:
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.

The UK is notifying the removal of 29 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: Alfentanil, Amoxicillin, Argipressin, Ceftriaxone, Clonidine, Co-amoxiclav, Codeine, Conjugated oestrogens and medroxyprogesterone acetate, Dalteparin, Diamorphine, Estradiol + Levonorgestrel, Estriol, Flucloxacillin, Gentamicin, Haloperidol, Insulin degludec + Liraglutide, Ketamine, Levofloxacin, Lorazepam, Metaraminol, Noradrenaline, Pantoprazole, Phenoxymethylpenicillin, Progesterone, Propofol, Remifentanil, Rocuronium, Tinzaparin, and Voriconazole.

The UK is also notifying the addition of 19 medicines to the list in critical short supply, and technical changes to an existing medicine from the list, in lieu of other shortage mitigations taking effect.

1. Azithromycin, Clarithromycin, Co-trimoxazole and Erythromycin (3004.20.00) are antibiotics used in the treatment of bacterial infections and were restricted for export following a national incident response being issued in response to the increasing cases of whooping cough across the UK.

2. Aztreonam (3004.20.00) is a critical medicine used in the treatment of gram-negative bacteria including pseudomonas. Global supply has been disrupted by a regulatory issue and there are currently no direct alternatives available.

3. Carbamazepine (3004.20.00) is a critical medicine used in the treatment of epilepsy. Supply has been disrupted by an issue with the quality of the finished product.

4. Disopyramide (3004.90.00) is a critical medicine used as a last line treatment for cardiac arrythmia. Supply has been disrupted by a manufacturing issue and prescribers have been advised to prescribe alternatives where these are suitable for the patient.

5. Iodixanol and Iohexol (3004.90.00) are dyes used for diagnostic purposes. These are first line alternatives for the current shortage of gastrografin oral solution, of which the supplier can only partially uplift to improve supply, therefore it is critical to ensure there is enough stock for UK patients/demand.

6. Olanzapine Embonate (3004.90.00) is a critical medicine used in the maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine and there is no direct alternative available. Disruption to supply has been caused by delays with supply chain routes due to distribution and market authorisation transfer.

7. Pancreatin (3004.90.00) is used for the treatment of pancreatic exocrine insufficiency. Prescribers are being advised to prescribe the unlicensed alternative until this issue is resolved.

8. Peginterferon (3004.90.00) is a critical medicine in the treatment of hepatitis and myeloproliferative neoplasms. The supply disruption has been caused by insufficient supplies of active pharmaceutical ingredients following an increase in demand.

9. Potassium Chloride (3004.90.00) is a critical medication used to treat deficiencies of potassium chloride in children. The shortage is due to a lack of availability of the stabilising ingredient.

10. Quetiapine (3004.90.00) is a critical medicine used in the treatment of schizophrenia and bipolar disorder. Disruption is due to various reasons including increased demand.

11. Salbutamol (3004.90.00) is a critical medicine for adults, adolescents and children aged under 11 years and babies to provide short-acting bronchodilation with a fast onset in reversible airways obstruction. The supply disruption has been caused by manufacturing issues and capacity constraints. There is no direct licensed alternative.

12. Sodium dihydrogen phosphate anhydrous (3004.90.00) is a critical medicine used for the treatment of hypercalcaemia (high calcium) or hypophosphataemia (low phosphate), and alternative measures are not able to resolve the issue alone.

13. Tirzepatide (3004.90.00) is used in the treatment of type 2 diabetes, and there has been an ongoing global supply disruption of these GLP-1 (glucagon-like peptide-1) receptor agonist medicines.

14. Vinblastine (3004.20.00) is a critical medicine used to treat a variety of cancers. Supply disruption has been caused by the single source supplier having a manufacturing site transfer.

15. Vitamin B substances with ascorbic acid (3004.50.00) are critical medicines used in the treatment of severe depletion or malabsorption of the water-soluble vitamins B and C. Supply has been disrupted by manufacturing issues resulting from a plant relocation. There is no direct alternative.

16. The UK is also notifying minor technical changes to an existing medicine on the restricted list. The pharmaceutical form for Exenatide (3004.39.00) is being amended from all pharmaceutical forms to prolonged-release solution for injection forms only.

These are temporary measures, in place to relieve critical shortages of medicines necessary for the protection of human health. Measures are reviewed regularly and only applied where the critical need cannot be met by alternative measures. We expect the next review to take place in around six months’ time.

HS 2022