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 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. Suppliers 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 continuity of 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.

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 the UK Government website:

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

Will there be any shortages of medicines and medical devices following the end of the EU Exit transition period?

The majority of medicine 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 recordin 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 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). This is the responsibility of traders (suppliers and hauliers) involved in the movement of goods and not health and social care organisations/providers or customers who order goods.

The new Trader Support Service (TSS) will have access to CDS and be able to complete declarations on traders’ behalf.

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.

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.

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 (suppliers and hauliers) 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.

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 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 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.

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.

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 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 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.

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.

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.

 

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