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Detailed guide: Businesses supplying medicines and medical devices: preparing for Brexit

Department Of Health

September 17
15:51 2019

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The UK will leave the EU on 31 October. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.

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The Department of Health and Social Care (DHSC) is working with industry on plans to minimise any medical supply disruption following a no-deal Brexit. This guidance summaries that approach. More information about it is in the letter to suppliers of medicines and medical products that come to the UK from or through the EU, Iceland, Lichtenstein or Norway.

Actions for businesses

DHSC is asking companies supplying the UK with medicines or medical products from or through the EU, Iceland, Liechtenstein or Norway to include the actions set out here in their Brexit planning. Companies can now determine for themselves the right mix of these actions for their specific situation, to most effectively ensure the continued flow of supplies.

Medicines

Actions for companies supplying the UK with medicines from or through the EU, Iceland, Liechtenstein or Norway, should, as appropriate, include:

  • securing capacity for rerouting freight away from Dover and Folkstone after 31 October 2019 to avoid the disruption expected to follow a no-deal Brexit

  • stockpiling a minimum of 6 weeks additional supply in the UK by 31 October on top of your business-as-usual buffer stocks

  • preparing logistics and supply chains to meet the new customs and border requirement for both importing and exporting - sometimes called trader readiness

  • ensuring continued supply to the NHS as part of the contingency programme

  • making alternative air freight plans for products with a short shelf-life or where production constraints mean stockpiling is not possible for example, medical radioisotopes

  • notifying DHSC of your companys plans

DHSC will keep working with companies to ensure that plans will lead to the continuity of medical supplies after Brexit.

To contact DHSC about planning actions, suppliers can email medicinescontingencyplanning@dhsc.gov.uk.

Medical devices and clinical consumables

In planning for Brexit, companies supplying the UK with medical products from or through the EU, Iceland, Liechtenstein or Norway should:

Batch testing and clinical trials

Certification of medicines

You must still get a UK-based Qualified Person (QP) to certify the batch testing and ensure compliance with the Marketing Authorisation (MA) and Good Manufacturing Practice (GMP) guidelines for any medicines:

  • manufactured in the UK

  • manufactured in a third country and directly imported into the UK (a third country is one with which we do not have any reciprocal arrangements)

A QP based in a country approved for import can still certify, release and assure compliance with the MA and GMP guidelines for any medicines:

  • manufactured in a country on the MHRAs approved country for import list

  • manufactured in a third country but imported into the UK from a country on the MHRAs approved country for import list

This wont require any further certification.

These arrangements will continue until the government thinks any further change is necessary. Well work with industry ahead of any changes that might impact suppliers. Well give at least 2 years notice of any changes to allow industry to fully prepare.

Supplies for clinical trials, including Investigational Medicinal Products (IMPs)

Sponsors of clinical trials or investigations running in the UK should:

review supply chains

put in place any necessary arrangements to assure supplies after Brexit

This includes supply chains relating to Investigational Medicinal Products (IMPs), as well as in-vitro diagnostic and other medical devices, advanced therapy medicinal products, radioisotopes and other clinical consumables.

Government actions to ensure supply continues

Summary of government actions

In preparation for Brexit, the UK government is:

  • supporting suppliers to secure alternative supply routes (away from the Dover and Folkestone crossings, where delays are expected)

  • encouraging buffer stocks and stockpiling (where this is practical) or asking industry or NHS Supply Chain to build up buffer stocks in the UK

  • adding to normal shortage management procedures, enabling ministers to issue serious shortage protocols to pharmacists

  • securing additional warehouse space for stockpiled medicines, including ambient, refrigerated and controlled drug storage

  • working with industry to improve trader readiness in preparation for the new customs procedures that will come into force on day 1 of a no-deal Brexit

  • changing or clarifying regulatory requirements so that companies can continue to sell their products in the UK

DHSC is working on these plans with trade bodies, product suppliers and the health and care system in England. DHSC is doing this in consultation with the devolved administrations (DAs). The DAs have also been working closely on Brexit planning with their health and social care systems.

People can be reassured by the governments plans for continued supply to the whole of the UK, Jersey, Guernsey and the Isle of Man following Brexit.

Re-routing supplies

DHSC is procuring an express freight service able to deliver small batches within 24 hours and a 2 to 4-day pallet delivery service.

The Department for Transport is procuring roll-on, roll-off freight capacity on which medicines and medical products would be prioritised.

Medical devices and clinical consumables

Part of DHSCs contingency planning involved analysing the supply chains of medical devices and clinical consumables. This identified the products routinely imported into the UK from other countries in the EU.

NHS Supply Chain colleagues are now working with suppliers who import from the EU to increase stock held at national level.

DHSC is also facilitating the continued movement of products that go directly to NHS organisations from other EU countries.

DHSC has set up a working group to test

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