EU Exit - Frequently Asked Questions

EU Exit - Frequently Asked Questions

Background

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 will apply from 1 January 2021, including medicines..  Guidance is referred to in the frequently asked questions section.

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. This 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 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 .  Specific guidance on the supplies 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.

Medical Supplies

What has the Department of Health been doing following the end of transition to ensure medicine supplies continue into Northern Ireland?

The Department has been working to ensure the supply of medicines, medical devices and other healthcare supplies are maintained following the end of the transition.

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 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 I.

In terms of supplies into NI, it was noted at the fourth Ireland/ Northern Ireland Specialised Committee on 5 November 2020 that the UK Government and the EU Commission had reached an agreed approach on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021 to allow the pharmaceutical industry 12 months from 1 January 2021 to comply with batch testing, importation and Falsified Medicines Directive requirements.

https://www.gov.uk/government/news/irelandnorthern-ireland-specialised-committee-05-november-2020

Have there been shortages of medicines and medical devices following the end of the EU Exit transition period and the introduction of the NI Protocol?

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 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 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 are the Department doing to prepare for the introduction of regulatory changes to the supply of medicines into NI 1 January 2022?

NI remains aligned to EU regulations and legislation in terms of medicines and their supplies as a requisite of the NI Protocol. From 1 January 2022 following the end of the pragmatic approach agreed by the UK and EU, medicines supplies from GB into NI will need to comply with FMD and importation requirements such as batch testing and Qualified Person (QP) certifications. The Department are working with DHSC and MHRA to develop plans and guidance for industry to help them prepare with these regulatory requirements.The Department and DHSC will continue to work with the pharmaceutical industry and wider supply to ensure medicines are supplied into NI.

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 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:

https://www.health-ni.gov.uk/sites/default/files/publications/health/HSC-SQSD-16-19.pdf

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 on a clinical trial will follow EU regulation 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.

Prescriptions

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?

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:

https://www.gov.uk/guidance/prescriptions-issued-in-the-eea-and-switzerland-guidance-for-pharmacists#eel-decline

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:

https://www.health-ni.gov.uk/sites/default/files/publications/health/Letter-approved-country-health-professionals.pdf

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 from 1 January 2022?

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.

Vaccines

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.

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.

Licensing

How are medicines licensed in NI following the end of the transition period?

From 1st January 2021 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 via:

https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra#licensing

Controlled Drugs

Will there be 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 12 month flexibility 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. Following the end of the transition period 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:

https://fmdsource.co.uk/2020/11/16/future-of-the-safety-features-measures-under-fmd-in-great-britain-and-northern-ireland/

https://fmdsource.co.uk/faqs/fmd-faqs-practical-implications-for-community-pharmacies/

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 from 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, at the end of transition . However the Department is awaiting further guidance and clarity from MHRA on this matter.

Customs Declarations

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 TSS.

https://www.tradersupportservice.co.uk/tss

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 via:

https://www.gov.uk/eori

More information on trade between GB and NI from 1 January 2021 can be found via:

https://www.nicustomstradeacademy.co.uk

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 on the link below:

https://register.gotowebinar.com/register/3420121489782610187

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:

https://www.gov.uk/guidance/apply-for-authorisation-for-the-uk-trader-scheme-if-you-bring-goods-into-northern-ireland-from-1-january-2021

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?

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 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 for in this scenario until 1 October 2021. However parcels with prohibited or restricted goods may require a declaration, regardless of the value of the goods. More information can be found via:

https://www.gov.uk/guidance/sending-parcels-between-great-britain-and-northern-ireland

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:

https://mailchi.mp/f699a349005b/uk-transition-important-regulatory-changes-affecting-practices-in-northern-ireland-from-1-january-2021?e=9fbf259286

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 until 1 October 2021. Prohibited or restricted goods to NI may require these certificates before this date. More information can be found via:

https://www.gov.uk/guidance/export-food-and-agricultural-products-special-rules#grace-period

Travel

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:

https://www.gov.uk/guidance/uk-residents-visiting-the-eueea-and-switzerland-healthcare

Travel advice is available at these links:

https://www.gov.uk/foreign-travel-advice(external link opens in a new window / tab)

https://www.nhs.uk/using-the-nhs/healthcare-abroad/apply-for-a-free-ehic-european-health-insurance-card/(external link opens in a new window / tab)

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.

http://www.hscboard.hscni.net/travelfortreatment/(external link opens in a new window / tab)

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.

https://www.gov.uk/settled-status-eu-citizens-families(external link opens in a new window / tab)

https://www.nidirect.gov.uk/articles/staying-northern-ireland-if-youre-eu-citizen(external link opens in a new window / tab)

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.

Frontier workers in the UK: rights and status - GOV.UK (www.gov.uk)

 

 

 

 

 

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