Department Of Health
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Get ready for Brexit 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.
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 firstname.lastname@example.org.
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:
review supply chains, assess how leaving the EU without a deal would impact product ranges and then make contingency plans
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 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 governments plans for continued supply to the whole of the UK, Jersey, Guernsey and the Isle of Man following Brexit.
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.