Guidance

Businesses supplying medicines and medical devices: preparing for Brexit

Guidance for businesses supplying medicines and medical devices about plans for a no-deal Brexit.

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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 summarises 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 – to avoid the disruption expected to follow if there is a no-deal Brexit

  • stockpiling a minimum of 6 weeks’ additional supply in the UK – 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’ – DHSC’s trader readiness unit can support suppliers with this

  • 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 company’s 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:

This won’t require any further certification.

These arrangements will continue until the government thinks any further change is necessary. We’ll work with industry ahead of any changes that might impact suppliers. We’ll 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 now:

• review supply chains

• put in place any necessary arrangements to assure supplies after Brexit

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

Within 12 months of Brexit, sponsors should secure the services of a manufacturing and import authorisation holder for IMPs and a QP to oversee the supply of IMPs from approved countries. There is no requirement to re-certify IMPs for use in a clinical trial if this has already been done in an approved country.

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 government’s plans for continued supply to the whole of the UK, Jersey, Guernsey and the Isle of Man following Brexit.

Re-routing supplies

DHSC has 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 has secured space on less busy shipping routes. Medicines and medical products are among the goods that would have access to this space as a priority.

Find out how suppliers can register to use these government freight services to keep medical products flowing into the UK.

Medical devices and clinical consumables

Part of DHSC’s 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 and refine its contingency plans and how suppliers will interact with these processes.

Batch testing and clinical trials

Certification of medicines

Without a deal, after Brexit, the UK will no longer be a member of the European Medicines Agency (EMA).

We will continue to recognise batch testing of human medicines carried out in:

  • the EU, Iceland, Lichtenstein and Norway

  • third countries with which the EU has a Mutual Recognition Agreement

For more information, read the list of countries approved for batch testing after the UK leaves the EU by the Medicines and Healthcare products Regulatory Agency (MHRA).

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

The UK will continue to accept batch testing and QP certification of IMPs manufactured in the EU, Iceland, Liechtenstein and Norway.

There will be no change to the current arrangements for batch testing of IMPs manufactured in third countries subject to UK oversight, as set out in the guidance about importing investigational medicinal products if the UK leaves the EU without a deal.

Read more about the regulation of medicines, medical devices and clinical trials in a no-deal Brexit.

Manufacturer’s Authorisation licences

Currently there are 2 Manufacturer’s Authorisation licences issued by the MHRA for importing licensed medicines into the UK: manufacturer and wholesaler. These would remain the same should the UK leave the EU without a deal.

Manufacturer licences

To qualify for a manufacturer licence to make, assemble or import human medicines, you must show the MHRA that you comply with EU good manufacturing practice and pass regular inspections of your site.

Wholesaler licences

To sell or supply medicines to anyone other than the patient using the medicine, you need a wholesaler licence. This is also known as a wholesale dealer licence or wholesale distribution authorisation. To qualify, you must comply with good distribution practice and pass regular inspections of your site.

Read more about importing medicinal products from the EU, Iceland, Lichtenstein or Norway if the UK leaves the EU without a deal.

Reporting supply issues

Continue to alert the DHSC’s medicine supply team of any supply problems as soon as possible.

After EU exit day, if you experience disruption to your supplies or you feel there is potential for disruption and usual procedures can’t resolve the matter, you can report it to National Supply Disruption Response (NSDR). NSDR has been set up to support the management of supply disruption.

Contact details for the NSDR will be shared with suppliers before the UK leaves the EU.

You can report the issue to NSDR whether the disruption is related to Brexit or not.

Published 6 February 2019
Last updated 11 October 2019 + show all updates
  1. Added information for sponsors of clinical trials about manufacturing and import authorisation holders and Qualified Persons.
  2. Updated with information on the more flexible approach suppliers can now take to help ensure the continuity of medical supplies following Brexit. It is a summary of the advice in the government's 26 June 2019 letter to suppliers, presented as actionable guidance.
  3. Updated 'Batch testing and clinical trials' section to include content published previously on the guidance page 'Batch testing medicines if there's no Brexit deal’ about human medicines imported to the UK, and human medicines manufactured in a country on the MHRA’s Qualified Person list. Also added information on the continuation of these arrangements.
  4. First published.