EU Exit - Frequently Asked Questions
The United Kingdom (UK) left the European Union (EU) on 31 January 2020 and moved into a transition period which ends on 31 December 2020. The UK Government and EU Commission are currently engaged in negotiations to secure a free trade agreement.
During the transition period the UK has continued to follow EU legislation and regulations but this will change on 1 January 2021. From 1 January 2021 NI will remain aligned to EU legislation and regulations and Great Britain (GB) will not.
The Ireland/Northern Ireland Protocol comes into effect from 1 January 2021 and will result in changes to regulations regarding medicines in relation to importation requirements and compliance with Falsified Medicines Directive. There will be a twelve month phased in approach of these regulations and this is not expected have an immediate impact on healthcare supplies at the end of the transition period. Further information will be provided on these issues in the coming months.
Separate to regulatory differences, under the Protocol, new customs rules and procedures for the movement of all goods from GB to NI will apply from 1 January 2021, including medicines. Traders of medicines must prepare for these new rules and can register with the Trader Support Service (TSS), which has been established to provide information on and facilitate customs declarations from 1 January 2021.
The UK Government has implemented a multi-layered approach to help ensure the continued supply of medicines and medical products to the whole of the UK, including NI, from the end of the transition period. The approach for a ‘no deal’ scenario has been modified to better reflect the context at the end of the transition, including the effects of the COVID-19 pandemic. The multi-layered approach includes (but is not limited to) supporting trader readiness, buffer stocks, extra ferry capacity and an express freight service for medicines and medical products. In addition across the UK enhanced arrangements are operating for surveillance of the medicines supply chain and associated shortage managements systems.
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive UK wide guidance on a wide range of topics for the pharmaceutical industry relating to the ending of transition, which is available on the UK Government website. The guidance covers a range of technical areas, such as licensing, pharmacovigilance and importing and exporting medicines.
Department of Health Preparation
What is the Department of Health doing to prepare for the end of the EU Exit transition period?
The Department of Health (DoH) fully understand that this is an uncertain and challenging time.
The safety and well-being of people receiving health and social care service is the Department’s top priority.
The Department is working to ensure the supply of medicines, medical devices and other healthcare supplies are maintained after the transition period and that the citizens of NI continue to have access to these supplies.
The Department of Health and Social Care (DHSC) in England have been co-ordinating the supply chain within the UK on behalf of all the Devolved Administrations. Officials from the Department have been working closely with DHSC, the Medicines and Healthcare products Regulatory Agency (MHRA), other NI and UK Departments and Devolved Administrations to mitigate any risk to the supply chain.
This multi-layered approach has resulted in national plans being developed to mitigate possible disruption to healthcare supplies that could arise from a ‘no deal’ scenario. These national plans have been reviewed and are updated on an ongoing basis with detailed input from Northern Ireland through ongoing meetings. These include (but not limited to) supporting trade readiness, buffer stock, extra ferry capacity and an express freight service for medicines and medical products.
In terms of supplies into NI, the UK Government and the EU Commission reached an agreement following the fourth Ireland/ Northern Ireland Specialised Committee on 5 November 2020 to allow the pharmaceutical industry and wider supply chain 12 months from 1 January 2021 to comply with regulatory requirements that apply only to NI as part of the NI Protocol. This agreement gives industry 12 months to adapt any changes they require to supply medicines into NI. Further information can be found via:
Will there be any shortages of medicines and medical devices following the end of the EU Exit transition period?
The majority of medicines and medical devices supplies into NI arrive via GB. Large quantities of these supplies come from the EU or have a supply touchpoint there. These supplies are normally transported into the UK every day via the short strait crossings (i.e. between Calais/ Dunkirk/ Coquelles and Dover/ Folkestone).
National plans to prevent potential customs-related delays for medical supplies have been agreed. These include additional and express ferry capacity, re-routing away from the short straits, supporting trader readiness for new customs and border arrangements and ensuring that additional buffer stocks are available within the UK where possible.
It is important to recognise that medicine and medical devices are manufactured as part of a global and highly complex industry. Therefore shortages of medicines and other medical supplies are not uncommon for reasons unconnected to the UK’s exit from the EU.
There are already national and locally tried and tested mitigation arrangements in place for dealing with any supply disruptions to ensure that patients continue to get the medicines and medical supplies they need. These include (but not limited to) communicating with the primary and secondary healthcare settings detailing any potential shortages or issues with the supply chain and the best alternative products.
No one can provide an absolute guarantee that there will not be any disruption to the supply of medicines and medical products if there is a ‘no deal’ scenario at the end of the transition period. Such an absolute guarantee could not be given in normal circumstances, regardless of EU Exit. However, we can assure the public that we are working very hard with all stakeholders to plan and mitigate against such disruptions.
Will there be changes to the supply of medicines into NI from GB from 1 January 2021?
There will be no immediate changes and the DoH has worked closely with the UK Government to ensure there would be no short term risk to the supply of medicines into NI from 1 January 2021.
This is because the UK Government and EU Commission have agreed to allow the pharmaceutical industry 12 months from 1 January 2021 to comply with new regulatory requirements which apply only to NI under the NI Protocol. This will give the industry time to make changes to adapt their operations to meet these requirements and reduce the risk of disruptions to the supply of medicines into NI from GB.
The Department and DHSC will continue to work with the pharmaceutical industry over the coming months to mitigate any issues that may arise and put in place measures to ensure the supply of medicines into NI is maintained.
How will medical devices be affected by the end of the transition period?
After the end of the EU exit transition period there will be a continued acceptance of EU rules on medical devices until July 2023. The UK will unilaterally recognise CE marked EU devices approved by EU approved bodies.
From July 2023 a UK Conformity Assessment (UKCA) marking will be required for devices to be placed on GB market. UKCA marked devices will not be permitted on the NI market unless accompanied by a CE mark and UKNI mark.
Legislation will change on 1 January 2021 to the 2002 Medical Device Regulations and will apply to the whole of the UK. Since NI will follow EU rules this legislative change will recognise that the EU Medical Device Regulation (2017/745) and the In Vitro Diagnostic Medical Device Regulation (2017/746) must be fully implemented in NI from May 2021 and May 2022 respectively.
Further advice on the requirements of Health Institutions in relation to these regulations and in particular, the in-house manufacture of medical devices, the provision of implant cards to patients, and the recording of Unique Device Identifiers for class III medical devices can be found via:
What new customs rules will apply under the Protocol?
Goods moving from GB to NI will need to have a completed digital import declaration. Declarations will need to be made onto the new Customs Declaration Service (CDS).
The new Trader Support Service (TSS) will have access to CDS and be able to complete declarations on traders’ behalf. Any businesses or service providers who purchase goods from GB are recommended to register with TSS.
These digital processes will be streamlined and simplified to the maximum extent, and will not require any export declaration, exit declaration, or customs and regulatory clearance for goods as they leave the rest of the UK for Northern Ireland.
The TSS will ensure that the process is straightforward even for businesses who have not previously engaged with customs, and that no direct costs are incurred. This will provide an end-to-end service which will guide traders through all import processes, including handling digital import and safety and security declarations on their behalf, at no additional cost.
The key step which traders should take to prepare for the end of the transition is to ensure that they have an EORI number. If they do not yet have one, they should apply for one now. The TSS will be able to guide traders through the process for doing this. More information on EORI can be found via:
Customs checks will be kept to an absolute minimum. The regime will be administered by UK authorities at their discretion - meaning a minimal proportion of checks only as required by the levels of risk.
More information on trade between GB and NI from 1 January 2021 can be found via:
A webinar dedicated to the healthcare sector was held on 18 December 2020. You can access this recording by registering on the link below:
Is there anything a business in NI can do to identify that the goods they are bringing in from GB are not ‘at risk’ of entering the EU market?
Yes. If you intend to bring goods into NI which you know are not ‘at risk’ of moving into the EU, then you can apply for authorisation under the UK Trader Scheme. This means there will be zero duty on goods moving from a business in GB to your business in NI. To find out more information and register with UK Trader Scheme, please follow the link below:
Is the DoH satisfied that there will be no delays on the transport of medical supplies across the Irish Sea?
The Department has been working with DHSC and do not anticipate any delays on the transport of medical supplies across the Irish Sea. However any delays with other goods crossing the Irish Sea could affect the transport of medical supplies.
It is also important that traders involved in the movement of medical supplies from GB into NI via the Irish Sea complete the appropriate digital declarations to keep the possibility of customs checks on their goods to an absolute minimum. This would help to minimise the possibility of delays on the transport of medical supplies across the Irish Sea.
Do dispensed medicines from GB to patients in NI require customs declarations?
If you are a supplier of dispensed medicines from GB to patients residing in NI you may wish to register with Trader Support Service who will be able to provide more information and guidance on this matter.
Will I still be able to get my prescription for medicines and medical products?
Yes. The Department of Health and Health and Social Care organisations have been involved in a multi-layered approach with the UK Government and other Devolved Administrations to ensure the supply of medicines and medical products are maintained through all scenarios.
Occasionally there can be shortages of medicines and medical products- unrelated to EU Exit. Departmental officials work closely with DHSC and other Devolved Administrations to identify any potential shortages or risks to the supply chain. If this happens you will be prescribed the best alternative to your usual medication, as is normal practice. This will ensure that your treatment continues as normal.
Should I keep ordering my repeat prescriptions and taking my medicines as normal?
Yes. Patients should order prescriptions and take their medicines as normal. Always follow the advice of GPs and other health professionals who prescribe your medicines and medical products. There is no need to order additional supplies.
Prescribers have been advised that they should not issue additional prescriptions for supplies of medicines.
There are enough medicines and medical products to meet current needs but if patients order extra prescriptions, or stockpile, it will put pressure on stocks, meaning that some patients may not get the medicine they need.
Should I ask my GP for a larger or longer prescription?
No. GPs have been advised to continue to prescribe medicines and medical products as normal.
What about over-the-counter medicines and medical products?
Pharmacy medicines, which can be bought over the counter from a pharmacy are covered by the multi-layered approach.
Will I still get medicine if I am on a clinical trial?
Patients receiving medicines on a clinical trial should receive and take their medicines as normal following the end of the transition period. They should always follow the advice of health professionals who supply the products.
Similar to medicines supplied on prescription, medicines on a clinical trial will follow EU regulation in NI but not in GB.
The agreement between the UK Government and EU Commission to allow the pharmaceutical industry 12 months from the end of the transition period to adapt to any regulatory changes to supplies into NI. This should ensure there are no short term risks to the supply of medicines on a clinical trial into NI.
What about unlicensed medicines and specials?
Unlicensed medicines and specials in NI will be under the same legislation as the rest of the UK and therefore supplies can continue as normal.
What about the supply of vaccines into NI?
DoH are working with PHE to ensure the continuity of supply for centrally-procured vaccines which includes those used in the children’s immunisation programme and there are additional supplies being held in Northern Ireland.
Vaccines that fall outside of the national immunisation programme, such as vaccines for travel and occupational health purposes have been included in the DHSC’s contingency plans. NI requirements are included within these plans.
NI will follow EU regulations in relation to vaccines and GB will not. The agreement between the UK Government and EU Commission to allow the pharmaceutical industry 12 months from the end of the transition period to adapt any regulatory requirements needed for supplies into NI should mitigate any short term risks to vaccine supplies from the UK stockpile.
Will my doctor/ HSC be able to get the information they need to treat me?
Yes, EU Exit will ONLY affect how health and social care information is exchanged with other countries, and especially the delivery of cross border services. It just makes matters a little more complicated, it does not stop information about you being exchanged in a secure, lawful manner.
- UK to EU: The UK government has determined that EU data protection standards are equivalent to UK standards and is content to transfer information to EU partners.
- EU to UK: EU uses an “Adequacy” process to review the data protection arrangements of non EU countries. Until that review process is completed personal data transfers may require the use of more formal mechanisms to demonstrate compliance with GDPR.
Health and Social Care organisations in Northern Ireland have worked with the Department of Health to identify information flows that might be affected and put the appropriate arrangements in place. These include revised contracts using EU approved “Standard Contractual Clauses – SCC’s” or Administrative Agreements.
Examples of services that may need to exchange health or social care information include:
- North west cancer services,
- Kidney dialysis – Southern Trust area
- Paediatric cardiac care
- NI Fire and Rescue border services
- Cross border transportation of patients
- Social care services
Will there be a need for additional controlled drug licences for trade between GB, NI and the EU market?
There will be no need for additional licensing beyond existing requirements that are required for controlled drugs for trade between GB and NI.
Similarly access to the EU market from the UK, including from NI, will not change at the end of transition. Traders should continue to undertake the necessary requirements that they have previously carried out when trading controlled drugs from NI to the EU and vice versa.
Falsified Medicines Directive
What about Falsified Medicines Directive (FMD)? Do end users still need to decommission medicines in NI?
Yes. Following the end of the transition period NI will remain aligned with EU legislation and regulation, end users in NI, including pharmacies, must continue to comply with FMD and will be required to continue to verify and decommission unique identifiers on medicines packs at the point of supply.
NI will remain connected to National Medicines Verification System (NMVS) facilitated by SecurMed UK. SecurMed UK will continue to provide end user registration and necessary support to enable the decommissioning of packs with FMD identifier features beyond the end of transition. More information can be found via:
Do pharmacies in GB need to comply with FMD for supplying dispensed medication to patients in NI?
Pharmacies in GB will not be connected to the National Medicines Verification System from 1 January 2021 and will no longer be required to comply with FMD.
The Department does not anticipate that dispensed medicines from GB being supplied to patients in NI will be required to follow EU regulatory requirements, including FMD, at the end of transition. However the Department is awaiting further guidance and clarity from MHRA on this matter.
Medicines and Medical Products Suppliers Queries
I am a supplier of medicines into Northern Ireland. Will I still be able to supply medicines to Northern Ireland following the end of the transition period?
Following the end of the transition period NI will remain aligned to EU rules and GB will not. Medicines and medical products entering into NI must meet these rules.
However the UK Government and EU Commission have reached an agreement to allow pharmaceutical companies and the wider supply chain 12 months from 1 January 2021 to comply with these requirements to supply into NI. This should allow the continued supply of medicines and medical products in the short term into the NI market.
A multi-layered approach involving the Department and DHSC has been working with industry to put in place flexible mitigation and readiness plans in preparation for new border and custom procedures.
The UK Government has also offered guidance for businesses and industry to be ready for the end of the transition period and you should sign up to the Trader Support Service and obtain an XI EORI number.
It will ultimately be up to each individual company to put in place their own plans to meet all requirements after the transition period. The Department and DHSC will continue to work with the pharmaceutical industry and wider supply chain to maintain the supply of medicines and medical products into NI.
Will I still be able to export/ import medicines that contain controlled drugs between NI and GB after the end of the transition period?
There will be no new licensing requirements under Misuse of Drugs legislation for companies moving controlled drug medicines from GB to NI as a result of the NI Protocol.
However medicines containing controlled drugs will be subject to EU regulations when placed on the NI market from GB. The UK Government and EU Commission have agreed a 12 month flexibility period to allow industry time to comply with these regulations at the end of the transition period.
Healthcare Professionals Queries
I am a service provider in NI (e.g. Dentist, GP, Optician, Pharmacist, etc.). I purchase goods from GB, do I need to complete customs declarations?
Goods moving from GB to NI will require customs declarations from 1 January 2021. Who completes these declarations is based on the Incoterms agreed between the supplier and receiver.
It is recommended that all businesses and service providers who move goods from GB into NI register with Trader Support Service (TSS). For more information, please see the Customs Declarations section.
I am a prescriber and my patients are asking for additional supplies of their medicines and medical products in the event of a ‘no deal’ scenario at the end of the transition period. What should I do?
Prescribers are being advised to continue prescribing as normal. There is no need to prescribe additional quantities and these should not exceed 56 days’ supply or 28 days’ supply for controlled drugs.
The Department has been working with colleagues in the Health and Social Care sector (HSC) and Trusts across NI to ensure this message is being communicated clearly and keeping them updated with any relevant developments.
Any excessive and unnecessary prescribing could lead to patients stockpiling medications which could have put a strain on the overall stockpiles and may result in other patients missing out.
I am a community pharmacist, will I be able to obtain medicines for patients following the end of the EU Exit transition period? Should I order additional medicines?
Community pharmacies should not stockpile additional medicines and medical products in preparation for the end of the transition period. Any additional stockpiling of medicines and medical products by individual pharmacies will put a strain on the overall stockpiles. This could result in other pharmacies and patients missing out.
The Department has been working with pharmacy representatives to ensure they are up to date with the latest developments in relation to the ending of the transition period.
DoH has also been working with DHSC, MHRA and the wider pharmaceutical supply chain to ensure the continuity of supplies of medicines and medical products into NI following the end of the transition period.
This multi-layered approach has resulted in a range of national plans including (but not limited to) to hold additional stock on UK soil and enhance the freight capacity or re-route supplies if required. NI is included in these plans.
The UK Government and EU Commission reached an agreement to allow the pharmaceutical industry and suppliers 12 months from 1 January 2021 to comply with regulations required for supplies into NI as part of the NI Protocol. This is a positive development for NI and should ensure supplies are maintained in the short term to allow industry and the supply chain to adapt their operations and logistics to meet these requirements.
I am a community pharmacist in NI. Can I dispense a prescription issued by a health professional from the EU after transition?
Yes. Prescriptions from EU/ EEA health professionals can still be dispensed in NI from 1 January 2021.
Some changes to the Human Medicines Regulations (HMR) 2012 were made by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. Following the end of transition, a prescription issued by ‘an approved country health profession’ can be dispensed in NI, provided all other legal requirements are met, as laid out under HMR 2012. The current list of approved countries and health professional will be reviewed at least every 3 years and can be found via:
Any changes to this list will be communicated to pharmacists in good time to enable them to amend of their practices appropriately.
Legislation relating to controlled drugs has not changed. Pharmacists cannot dispense a controlled drug, listed in Schedule 1,2 or 3 of the Misuse of Drugs Regulations (NI) 2002, against a prescription issued by an approved country health professional.
Similarly, pharmacists cannot dispense medicines that do not have a valid Marketing Authorisation against a prescription issued by an approved country health professional.
A pharmacist should also continue to exercise their professional judgement when deciding to dispense a prescription issued by an approved country health professional.
Please see letter sent to community pharmacies by Canice Ward, Head of Medicines Regulatory Group:
I am a healthcare professional who manages the clinical care plan of my patients, many of whom are prescribed medication. Can you guarantee my patients will still get the same medication?
Even under normal circumstances, the Department cannot give this guarantee. Medicines and medical products are part of a complex and global supply network. Shortages of medicines and medical products within the supply chain are not uncommon- regardless of the ending of the EU Exit transition period.
In terms of planning for the end of the transition period the Department, in collaboration with colleagues in DHSC and the other Devolved Administrations, have been working to put in place national plans to mitigate against any risks to the medicines supply chain.
In the event of a disruption or any shortages, national and local arrangements are in place to mitigate any effects they may have in primary and secondary care. These include (but not limited to) the use of legislative powers under the Serious Shortage Protocol and supplying risk alerts to prescribers and suppliers, offering alternative products to ensure patients continue to receive the best treatments available.
I am a healthcare professional who imports human tissues and cells from GB. Are there any regulatory changes from 1 January 2021?
Yes. The Human Tissue Authority (HTA), the regulator of human tissue and organs in the UK, has issued guidance in relation to this. From 1 January 2021, any establishment in NI that receives human tissues or cells from GB will require a HTA import licence to carry out this activity. Please follow the link for more details:
I am running a clinical trial. Will my patients continue to receive their clinical trial medication?
The pharmaceutical industry has been given 12 months to comply with regulations required only in NI as part of the NI Protocol. This should mitigate against any short term risks to the supply of clinical trial medicines in NI.
DoH is aware that many within the Health and Social Care setting will have concerns around the supply of medicines into NI following the end of the EU Exit transition period.
The Department can only reassure you that all possible mitigations are in place to remove any potential risks associated with the end of the transition period. We will continue to work with DHSC, MHRA, other Devolved Administrations and colleagues across the health and social care sector to ensure the supplies of medicines and medical products are maintained and the citizens of NI continue to have access to these supplies.
If I visit Europe from 01 January 2021 will I still be able to use my European Health Insurance Card (EHIC)?
EHICs may not be valid from 1 January 2021 unless the UK comes to an agreement with the EU.
However if you have citizens’ rights under the EU Withdrawal Agreement you will be able to apply for a new EHIC. Applications for new EHICs are currently only open to certain categories of people.
Before you travel make sure you take out travel insurance with medical cover for your trip.
If you have a pre-existing medical condition, you should make sure your insurance company is aware so that they can make sure you are adequately covered.
You may not have access to free emergency medical treatment and could be charged for your healthcare if you do not get health cover with your travel insurance.
Travel advice is available at these links:
What happens if I go on a trip to the EU over the end of the transition period?
You can still use your EHIC for visits to an EU country that start in 2020 and end in 2021.
If you're visiting an EU country over the Christmas and New Year period, your UK EHIC entitlements will continue until you leave that country to either:
- return to the UK
- visit another EU country
I am a student studying in the EU will I still be able to use my EHIC?
Students who are habitually resident in the UK and studying in the EEA or Switzerland before 31 December 2020 will still be able to use their EHIC for immediate and necessary healthcare for the duration of their course. However, from 01 January 2021, this cover will be restricted to their country of study.
Will I still be able to pay for treatment in the EU and claim reimbursement?
The Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (CBHD), will continue to apply until 31 December 2020.
From 01 January 2021 the CBHD will no longer apply to the UK unless the UK comes to an agreement with the EU on this matter. However, patients from Northern Ireland whose treatment has been applied for, authorised or commenced, on or before 31 December 2020 will be able to complete their treatment and seek reimbursement.
Access to Healthcare in Northern Ireland
I am an EU citizen living in Northern Ireland – do I need to do anything to maintain entitlement to healthcare?
If you are already registered with a GP you will not need to do anything further.
If you are not already registered with a GP you will need to be able to demonstrate that you were in the UK before the end of transition and are intending to live here and not just on a visit.
To register after 30 June 2020 you will need to show you have registered with the EU Settlement Scheme.
If you are an EEA Citizen (not including Irish Citizens), to make sure you maintain your rights it is important that you apply for the EU Settlement Scheme. The EU Settlement Scheme is open to all eligible EEA citizens and their family members. You will have until 30 June 2021 to apply.
I am an Irish Citizen living in Northern Ireland, do I have to do anything?
If you are an Irish Citizen living in Northern Ireland and have used your right of free movement to live in Northern Ireland you too will be in scope of the EU Withdrawal Agreement.
If you are already registered with a GP you will not need to do anything further.
If you are not already registered with a GP you will need to be able to demonstrate that you were in the UK before the end of transition and are intending to live here and not just on a visit.
You will not need to do anything to maintain these rights but it might be advisable to keep documents safe for the future to show that you live and work in Northern Ireland before the end of transition and continued to do so afterwards.
I am a frontier worker?
If you live in Ireland and work in Northern Ireland you’ll be able to keep your frontier worker status if you’re frontier working in the UK by 31 December 2020 and continue to do so.
If you are already registered with a GP you will not need to do anything further. There will be an annual review of your frontier worker status as there is currently.
If you are not already registered with a GP you will need to be able to demonstrate that you were a frontier worker before the end of transition and still are.
If you are an EEA citizen apart from Irish you’ll need to apply for a frontier worker permit. This scheme is due to open on the 10 December for applications. You will need to have a valid permit by 1 July 2021.
Irish citizens will not need a frontier worker permit but may apply for one if they wish.
If you are a British citizen or a Person of Northern Ireland you will not need to do anything and you cannot apply for a frontier worker permit.