The United Kingdom (UK) left the European Union (EU) on 31 January 2020 and moved into a transition period which ended on 31 December 2020 with the UK and EU agreeing to a Trade and Cooperation Agreement on 24 December 2020.
During the transition period the UK continued to follow EU legislation and regulations but this changed on 1 January 2021. From 1 January 2021 Northern Ireland (NI) has continued to be aligned to EU legislation and regulations in respect of medicines and medical devices as a requisite of the Ireland/ Northern Ireland Protocol and Great Britain (GB) has not.
The Ireland/Northern Ireland Protocol which came into effect from 1 January 2021 has resulted in changes to regulations regarding medicines in relation to importation requirements and compliance with Falsified Medicines Directive. The UK and EU agreed to a phased in approach of these regulatory requirements until 31 December 2021 to allow time for industry to prepare.
Separate to regulatory differences, under the Protocol, new customs rules and procedures for the movement of all goods from GB to NI have come into force since 1 January 2021, including medicines. Guidance is referred to in the frequently asked questions section.
The UK Government 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. This included (but was 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 continuing to operate 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 range of topics for the pharmaceutical industry relating to the end of the transition period. Guidance on the supply of medicines into NI from January 2022 is also included. The guidance on the UK Government website covers a range of technical areas, such as licensing, pharmacovigilance and importing and exporting medicines.
On 6 September 2021 the UK Government announced that to give certainty and stability to businesses while UK-EU discussions proceed, the UK Government will maintain “standstill” arrangements, under which it will continue to operate the NI Protocol on its current basis.
More information is available at the following links:
- UK statement following the meeting of the Ireland/Northern Ireland Specialised Committee - 5 November 2020
Advice provided on the UK Government website further states the following: “The Government will ensure that reasonable notice is provided in the event that any of these arrangements are to change, to enable businesses and citizens to make appropriate preparations. Further information will be provided soon.”
Further to this on 17 December 2021 the EU Commission announced proposals on medicine supply issues in the context of the implementation of the NI Protocol (NIP) and published a written statement.
The EU Commission’s proposal includes an extension to the existing grace period for medicines to provide time to put in place long term legislative solutions. The EC has stated that there will be an extension of the Commission's interpretive note that will last until the end of 2022 unless the legislative procedure is finalised sooner.
What has the Department of Health been doing to ensure medical supplies into Northern Ireland continue?
The Department has been working to ensure the supply of medicines, medical devices and other healthcare supplies are maintained.
The Department of Health and Social Care (DHSC) leads on the arrangements for maintaining healthcare supply chains on behalf of the devolved administrations. Officials from the Department have been working closely with the DHSC, the MHRA, other NI and UK Departments and Devolved Administrations to mitigate any risk to the supply chain.
Have there been shortages of medicines and medical devices following the UK’s departure from the EU?
The pragmatic approach agreed by the UK and EU in relation to importation and Falsified Medicines Directive (FMD) requirements when supplying medicines from GB to NI has helped to ensure the continued flow of medicines into NI following the end of the transition period. The plans developed prior to the end of EU exit transition including supporting trader readiness for new customs and border arrangements and the provision of additional buffer stocks within the UK and NI where possible, appear to have largely mitigated against shortages of medical supplies following the end of the transition period.
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 EU exit and the NI Protocol.
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 primary and secondary healthcare professionals and 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 in the future irrespective of EU exit however, we can assure the public that we are working with all stakeholders to mitigate against such disruptions.
What is the Department doing to prepare for the introduction of regulatory changes to the supply of medicines at the end of the grace period?
NI remains aligned to EU regulations and legislation in terms of medicines and their supplies as a requisite of the NI Protocol. The Department is working with the DHSC and the MHRA to develop plans and guidance for industry to help them prepare with these regulatory requirements. The Department and the DHSC will continue to work with the pharmaceutical industry and wider supply to ensure medicines are supplied into NI.
New guidance and information from the MHRA is available on the UK Government website.
What is the Northern Ireland MHRA Authorised Route (NIMAR)?
In addition to the negotiations between the UK Government and the EU Commission, the MHRA and the DHSC have been working closely with Department of Health (DoH) officials to create a contingency measure to further support the supply of medicines in NI. This measure has been operational since 1 January 2022.
On 16 December 2021 the UK Government introduced a statutory instrument entitled the Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021. These regulations were brought forward to establish the Northern Ireland MHRA Authorised Route (NIMAR), which will help to ensure that people in Northern Ireland can continue to access the medicines they need.
This regulatory approach is based on an existing EU directive. It ensures patients in NI can access prescription only medicines at the same time as patients in GB. All medicinal products using NIMAR will have met the MHRA’s stringent requirements for safety, quality and efficacy.
Doctors, pharmacists, and patients in NI do not need to do anything differently to prescribe or access medicines through this route. It is a legal measure to help support supply chains into NI where required.
Medicines on the NIMAR list will all be licensed by the MHRA in GB and authorised to be supplied to Northern Ireland, on an unlicensed basis, where no licensed alternative is available. All medicinal products using NIMAR will have met the MHRA’s stringent requirements for safety, quality and efficacy.
The NIMAR list can be accessed on the .gov.uk website.
How have medical devices been 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 CE marked medical devices until July 2023. The UK will unilaterally recognise CE marked EU devices approved by EU approved bodies.
However, if a GB manufacturer does not market their device in the EU and is required to recertify their device before July 2023, they will do so to the UK MDR (2002). These devices would not be able to be supplied to NI as they will carry the UK Conformity Assessment (UKCA) marking.
From July 2023 the UKCA marking will be required for all devices to be placed on GB market. UKCA marked devices will not be permitted on the NI market unless accompanied by a CE mark or CE UKNI mark.
Legislation changed on 1 January 2021 to the 2002 Medical Device Regulations and applied 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.
From 1 January 2021 the 2002 Medical Device Regulations continued to apply in GB and NI. Since NI follows EU rules EU Medical Device Regulation (2017/745) apply in NI from May 2021. With regard to In Vitro Diagnostic Medical Devices Regulation (2017/746) this will fully apply in NI from May 2022.
The EU MDR were to have applied across the UK in May 2020 however this was delayed due to the pandemic.
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 on the Department of Health website.
Further information on the regulation of medical devices can be found on the UK Government website.
What about over-the-counter medicines and medical products?
Pharmacy medicines which can be bought over the counter from a pharmacy are included in the multi-layered approach to ensuring continued supplies of medicines into the UK following the end of the transition period.
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 used for clinical trial purposes will follow EU regulations in NI but not in GB.
What about unlicensed medicines and specials?
Unlicensed medicines and specials in NI will fall under the same legislation as the rest of the UK and therefore supplies can continue 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 healthcare 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.
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. Prescribers are being advised that there is no need to prescribe additional quantities and these should not exceed 56 days’ supply or 28 days’ supply for controlled drugs.
I am a community pharmacist in NI. Can I dispense a prescription issued by a health professional from the EU following the transition period?
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 on the UK Government website.
Any changes to this list will be communicated to pharmacists in good time to enable them to amend 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 following the end of the medicines grace period?
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 EU Exit.
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.
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 NI.
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.
How are medicines licensed in NI following the end of the transition period?
There are a number of options available for companies who wish to gain a licence (marketing authorisation) for a medicine for use in Northern Ireland.
- Marketing authorisations approved in the European Union centralised procedure will automatically have effect in NI.
- NI may also be included in decentralised or mutual recognition procedures as a concerned member state.
- MHRA can also approve a medicine for use in NI, GB or the whole of the UK.
Updated advice and guidance from MHRA on the licensing of medicines throughout the UK can be found on the UK Government website.
Is there a need for additional controlled drug licences for trade between GB, NI and the EU market?
There is no need for additional licensing beyond the requirements that existed prior to the end of EU exit transition for controlled drugs for trade between GB and NI.
Similarly access to the EU market from the UK, including from NI, has not changed following the end of transition. Traders should continue to undertake the necessary requirements that they previously carried out when trading controlled drugs from NI to the EU and vice versa.
I am a medicines wholesaler and I export/ import medicines that contain controlled drugs between NI and GB. Are there any additional licences or requirements for moving these goods?
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 grace period to allow industry time to comply with these regulations at the end of the transition period.
It is also important to note that controlled drugs are not considered controlled goods in terms of movement between GB and NI. Therefore controlled drugs do not have any additional customs requirements when moving from GB to NI.
Falsified Medicines Directive
What about Falsified Medicines Directive (FMD)? Do end users still need to decommission medicines in NI?
Yes. NI has continued to remain aligned with EU legislation and regulation. Therefore end users in NI including community 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 has remained connected to the National Medicines Verification System (NMVS) facilitated by SecurMed UK. SecurMed UK have continued to provide end user registration and necessary support to enable the decommissioning of packs with FMD identifier features following the end of transition. More information can be found via SecurMed and the UK Government website.
Do pharmacies in GB need to comply with FMD for supplying dispensed medication to patients in NI?
Pharmacies in GB have been disconnected from the National Medicines Verification System since 1 January 2021 and are no longer 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. However the Department is awaiting further guidance and clarity from MHRA on this matter.
What new customs requirements have applied under the Protocol?
Goods moving from GB to NI now 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) has access to CDS and is able to complete declarations on traders’ behalf. Any businesses or service providers who purchase goods from GB are recommended to register with Trader Support Service.
These digital processes are being 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 are helping to ensure that the process is straightforward even for businesses who have not previously engaged with customs, and that no direct costs are incurred.
The key step which traders should take to prepare for these new customs declarations is to ensure that they have an XI EORI number. The TSS will be able to guide traders through the process for applying for an EORI number. More information on EORI numbers can be found on gov.uk website:
More information on trade between GB and NI from 1 January 2021 can be found via NI Customs & Trade Academy:
A webinar dedicated to the healthcare sector in relation to customs requirements was held on 18 December 2020. You can access this recording by registering online.
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 to the gov.uk website.
Are medical supplies sent from businesses in GB direct to residents in NI exempt from customs requirements?
No. All goods moving from GB to NI require customs declarations.
However, the UK Government has unilaterally extended the temporary approach to applying customs declaration requirements for parcels being sent by GB businesses to residents in NI until 6 months after guidance is published on this matter. This means GB medical suppliers are currently exempt from completing declarations when supplying residents in NI.
The Department will be seeking assurances from GB medical suppliers that they are trader ready for completing customs declarations prior to the introduction of these requirements.
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?
From 1 January 2021 goods moving from GB to NI businesses have required customs declarations. Who completes these declarations is based on the Incoterms agreed between the consignor and consignee.
It is recommended that all businesses and service providers who move goods from GB into NI register with Trader Support Service (TSS) and obtain an XI EORI number.
Parcels being sent from businesses in GB to businesses in NI with a value of goods under £135 are currently exempt from requiring customs declarations. The UK Government unilaterally extended the temporary approach to applying customs declarations in this scenario. However parcels with prohibited or restricted goods may require a declaration, regardless of the value of the goods. More information can be found online at the gov.uk website.
I am a community pharmacist and I order gluten-free bread from GB for a patient. I am responsible for declarations, are there any additional customs requirements?
If the bread contains products of animal origin, it may be considered a controlled good. If a product is considered a controlled good additional information may need to be supplied prior to the movement of the good from GB to NI.
Traders may wish to contact the manufacturer and TSS for further information that they may require.
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 a wholesaler who moves goods from GB to NI that require official certificates such as Export Health Certificates (EHC) and phytosanitary certificates. When do I require these certificates for moving these goods?
The UK Government unilaterally extended the arrangement to allow authorised traders that move goods that require official certificates from GB to NI to move these goods without the need for official certification. Prohibited or restricted goods to NI may require these certificates following the end of this arrangement. More information can be found online via gov.uk.
If I visit Europe from 01 January 2021 will I still be able to use my European Health Insurance Card (EHIC)?
The UK reached an agreement with the EU on 30 December 2020 and temporary visitors from the UK will continue to have access to emergency and necessary healthcare cover when they travel to the EU.
When you travel to an EU country you should have:
- a European Health Insurance Card (EHIC), or
- a UK Global Health Insurance Card (GHIC), and
- travel insurance with healthcare cover
An EHIC or GHIC is not a replacement for travel insurance. Make sure you have both before you travel.
If you do need to access healthcare while you are in the EU and do not have a current EHIC or GHIC or your card is lost or stolen abroad you might be able to get a Provisional Replacement Certificate (PRC).
To apply for a Provisional Replacement Certificate (PRC) call the Overseas Healthcare Services. This is part of the NHS Business Services Authority (BSA).
NHS Overseas Healthcare Services
Telephone: +44 (0)191 218 1999
Monday to Friday, 8am to 6pm
If you’re travelling to Switzerland, Norway, Iceland or Liechtenstein
Currently an EHIC or GHIC cannot be used to access medically necessary healthcare in Switzerland, Norway, Iceland or Liechtenstein. You should get appropriate travel insurance with healthcare cover before you travel, including cover for pre-existing conditions.
In Norway you can use a UK passport to get medically necessary healthcare (for example emergency treatment or to treat a pre-existing condition).
Information on EHICs, GHICs and PRCs is available at this link:
Travel advice is available at these links:
I am a student studying in the EU will I still be able to use my EHIC?
Students that are habitually resident in the UK who wish to study in an EU Member State will still be able to use an EHIC/GHIC to access emergency and necessary healthcare for the duration of their studies.
I am a student studying in Norway, Iceland, Liechtenstein or Switzerland will I still be able to use my EHIC?
Students that are habitually resident in the UK and studying in Norway, Iceland, Liechtenstein or Switzerland before 31 December 2020 will be able to use their EHIC to access emergency and necessary healthcare for the duration of their course.
Currently Norway, Iceland, Liechtenstein and Switzerland do not have long term agreements with the UK. Therefore students that are habitually resident in the UK that start a course of study in Norway, Iceland, Liechtenstein or Switzerland from 1 January 2021 will not have access to free healthcare and should get appropriate travel insurance with healthcare for the duration of their studies.
Will I still be able to pay for treatment in the EU and claim reimbursement?
From 01 January 2021 the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (CBHD), no longer applies to the UK. 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.
There is currently no replacement scheme available.
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 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.
- 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 1 January 2021 and are intending to live here and not just on a visit.
- To register with a GP after 30 June 2020 you will need to show you have registered with the EU Settlement Scheme.
I am an Irish Citizen living in Northern Ireland, do I have to do anything?
Irish Citizens have a right to live and work in the UK. If you are living in Northern Ireland as an ordinary resident you will be able to apply to register with a GP.
If you are already registered with a GP you will not need to do anything further.
As an Irish Citizen living in Northern Ireland before 31 December 2020 you will be in scope of the EU Withdrawal Agreement. 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, do I have to do anything?
Frontier workers working in the UK by 31 December 2020
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. This will be the process until the 30 June 2020.
From 30 June 2020, if you are an EEA citizen, apart from Irish, you’ll need to apply for a frontier worker permit to enter the UK as a protected frontier worker. 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.
Frontier workers starting work in the UK from 1 January 2021
If you are an EEA citizen and start frontier working in the UK on or after 01 January 2021 you will be subject to the immigration rules and will need a visa to travel to, and work in the UK.
Irish nationals will always be here lawfully and do not need a visa to travel and work in Northern Ireland.
To access publicly funded healthcare in Northern Ireland you will need to register with a GP and you will need to be able to demonstrate that you are a frontier worker. This will usually be by presenting your visa.