Brexit and the Regulation of Health Products – Latest Information
The United Kingdom left the European Union on 1 February 2020 after both sides concluded a Withdrawal Agreement to facilitate an orderly departure. The Withdrawal Agreement also provides for a transition period. The transition period is intended to give time for national administrations, businesses and citizens to get ready for the significant and enduring changes that will definitively arise on 1 January 2021 as a result of the UK’s decision to leave the EU.
Whether you're a concerned citizen or wondering how Brexit may affect your business, visit the Government website gov.ie/brexit to keep up to date on the latest news and advice. This includes the Brexit Readiness Action Plan which sets out the steps that businesses and individuals need to take now, to be ready for the end of the Transition Period on 31 December 2020.
The HPRA will provide information on this dedicated section of our website to keep stakeholders informed of developments related to Brexit and the health products we regulate.
Download our Brexit Transition Period Checklist for medicines and medical devices.
Please see our detailed Brexit guidance document for human and veterinary medicines (last updated October 2020). You can also visit the dedicated Medical Devices Brexit page or Cosmetics page for relevant updates. Our additional background information relating to Brexit is also available.
The HPRA continues to advise companies to engage with us at the earliest opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market.
Companies can submit Brexit queries to the relevant e-mail address below:
Human Medicines – firstname.lastname@example.org
Veterinary Medicines – email@example.com
Medical Devices – firstname.lastname@example.org Cosmetics - email@example.com
7 October 2020 - HPRA publishes updated Brexit Guidance Document for Human and Veterinary Medicines
The latest version of our Brexit Guidance document for industry stakeholders has been updated to reflect the latest information from the EU Commission, including the updated notice to stakeholders (March 2020). It also includes updates and provides links to the latest information from the EMA, the CMDh (Co-ordination group for Mutual recognition and Decentralised procedures – human), and the CMDv (Co-ordination group for Mutual recognition and Decentralised procedures – veterinary).
Updates have been made to much of the content including the following sections:
- Multilingual packaging and joint labelling
- Post Brexit licensing scenarios for marketing authorisation holders
- Product testing for QP certification/release
The HPRA approach has been consistent with the work of the Commission and the EU human medicines, veterinary medicines and medical device networks calling on all stakeholders to ensure that they are prepared for every eventuality, including the worst-case scenario of a ‘no-deal’ Brexit. The guidance in this document is based on a potential ‘no-deal’ scenario. However, should the evolving political situation allow for the preparation of a more central case scenario, the document will be updated as appropriate.
22 April 2020 — Brexit Transitional Period: Implications for Cosmetic Product Companies up to 31 December 2020
The HPRA wishes to highlight that the European Commission published two Readiness Notices in the form of Notice to Stakeholders on 13 March 2020 that are relevant to cosmetic products.
The Notice to Stakeholders regarding the Withdrawal of the UK and EU rules in the field of cosmetic products replaces that previously published on 18 July 2019.
The Notice to Stakeholders regarding Withdrawal of the United Kingdom and EU rules in the field of industrial products replaces previous publications by the European Commission: the Notice to Stakeholders of 22 January 2018 and the Q&A document dated 1 February 2019.
Further information on the above is available on the Cosmetics section of the website.
The HPRA encourages responsible persons, distributors, manufacturers and retailers of cosmetic products to consult the details of both published Notices to Stakeholders and to take the appropriate steps in preparation for the end of the transition period to ensure supply of compliant cosmetic products to the Union market.
If there are any specific queries, these can be sent to firstname.lastname@example.org.
20 February 2020 — Brexit Transitional Period: Implications for Medicine and Medical Device Companies up to 31 December 2020
The UK left the European Union on 31 January 2020 on the basis of the Withdrawal Agreement
which was agreed by the European Council on 17 October 2019. The agreement includes a transition period
until at least 31 December 2020.
The EU and the UK will start negotiations on a new future relationship agreement which, if agreed, is due to come into effect from 1 January 2021.
While the UK remains part of the free trade block and subject to EU law during the transition period, it cannot act as lead Member State and cannot be part of the EU institutions. The HPRA has provided information about what this means for medicine and medical device companies.
The information is available on the News section
of our website.
Additionally, our Brexit Transition Period Checklist (below) outlines key steps for companies.
1 October 2019 - Have you verified if your cosmetic product has a Responsible Person registered within the EU-27 member states?
On 1 February 2019, the EU Commission published a Q&A document to provide further information on the impact of a no deal Brexit on cosmetic products (and other products covered under the New Approach legislation).
This Q&A follows on from the publication by the Commission of two ‘Notice to Stakeholders’ on 22 January 2018 and on 29 November 2018, and highlights some of the implications on labelling, representation and supply in the event of ‘no deal’ Brexit. The ‘Notice to Stakeholders” of 29 November 2018 was updated and replaced on 18 July 2019.
Further details can be found on our cosmetic products Brexit page.
17 September 2019: Brexit Preparedness - HPRA Highlights Medical Device Regulatory and Supply Requirements in advance of 31 October 2019
The HPRA is in ongoing contact with companies across the Medtech industry to once again highlight particular regulatory and supply matters linked to Brexit.
In respect of regulatory compliance, detailed information is included in our June newsletter. This document highlights clearly the regulatory changes that companies need to implement in respect of issues such as the transfer of certificates from UK notified bodies to an EU-27 notified body, relocation of UK based European Authorised Representatives within the EU-27 or the designation of a European Authorised Representative within the EU 27 for UK manufacturers.
With regard to the supply of medical devices, companies are requested to take the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading to up to 31 October 2019 and post Brexit. This includes consideration of stocks in the supply chain and ensuring arrangements are in place to allow for timely replenishment of such stocks including custom requirements where applicable and allowing for potential delays during transportation.
Further information is available from the News section of our website.
02 September 2019: Brexit Preparedness - HPRA Highlights Medicines Regulatory and Supply Requirements in advance of 31 October 2019
The HPRA is in ongoing contact with companies across the pharmaceutical industry to once again highlight particular regulatory and supply matters linked to Brexit.
In respect of regulatory compliance, detailed information is included in the HPRA Brexit Guidance. This document highlights clearly the regulatory changes that companies need to implement in respect of issues such as the transfer of UK based marketing authorisations, batch testing and batch release. It is kept up-to-date to incorporate the most recent guidance from the European Commission, the EMA and the HMA.
With regard to the supply of medicines, companies are requested to take the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading to up to 31 October 2019 and post Brexit. This includes consideration of stocks at wholesale level and ensuring arrangements are in place to allow for timely replenishment of such stocks including custom requirements where applicable and allowing for potential delays during transportation.
Further information for both human medicines and veterinary medicines is available from the News section of our website.
26 April 2019 - HPRA publishes updated Brexit Guidance Document for Human and Veterinary Medicines
The latest version of our Brexit Guidance document for industry stakeholders has been updated to incorporate information in respect of batch testing rules and to reflect the latest European Commission Q&A. It also addresses queries raised at our Brexit stakeholder event on 1 February 2019. The guidance provided is based on our current understanding of the potential legal impact of an exit by the UK.
It is important to again note that guidance is evolving and must be agreed in respect of so-called ‘grey’ areas. Therefore, the advice currently provided may require updating as the negotiation process continues. In the event that a transition period is agreed, this guidance will be updated to reflect the terms of the transition.
17 April 2019 - Have you verified if your cosmetic product has a Responsible Person registered within the EU-27 member states?
On 1 February 2019, the EU Commission published a Q&A document to provide further information on the impact of a no deal Brexit on cosmetic products (and other products covered under the New Approach legislation).
This Q&A follows on from the Commissions’ January 2018 notice to stakeholders and November 2018 notice to stakeholders, and highlights some of the implications on labelling, representation and supply in the event of no deal.
The latest Q&A provides examples of when goods are placed on the market and in the supply chain, which includes clarification on the requirements in relation to presentation of the Responsible Person (RP) contact details on the labelling.
The Q&A also reinforces the importance of updating the Cosmetic Product Notification Portal (CPNP) for products currently registered with a RP in the UK. In the event of a no-deal Brexit, all cosmetic products made available to the EU market as of the date of withdrawal date are required to be registered on CPNP with a RP of one of the EU-27 member states. Information is available regarding transfer of an existing notification in CPNP to a future EU-RP in the Commission’s November 2018 notice to stakeholders.
In the context of the UK becoming a 3rd country post Brexit, the HPRA takes this opportunity to remind Irish entities sourcing products from the UK for supply to the EU-27 to be aware that they will become an importer and potentially the RP for the product if one has not already been designated in the EU-27.
The HPRA is continuing to work with the European Commission and other Member States in relation to cosmetic product issues arising from Brexit.
The HPRA encourages any responsible persons, distributors, manufacturers or retailers to take the appropriate steps in preparation for Brexit in relation to supply of compliant cosmetic products to the market. If there are any specific queries, these can be sent to email@example.com.
EU Commission Q&A
EU Commission Notice to Stakeholders January 2018 EU Commission Notice to Stakeholders November 2018
26 March 2019 - European Medicines Agency publishes Brexit questions-and-answers document
The EMA has published a Q&A document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.
It explains that in case of a withdrawal agreement, there will be a transition period during which EU law will continue to apply in the United Kingdom. This means that access to medicines will not be affected.
If the UK leaves without a withdrawal agreement or deal (‘no-deal scenario’), EU law will cease to apply in the UK. In this case, in order to be able to continue to supply medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.
7 March 2019 - Are your medical devices certified by a UK Notified Body?
Medical devices certified by a Notified Body (NB) and placed on the EU market after 29 March in the case of a no-deal Brexit, will require Notified Body certification from an EU 27 Notified Body in order to continue to be legally placed on the EU market. For more information see our Medical Devices Brexit page.
6 March 2019 - Time-limited exemption to continue batch control testing in the UK after the UK’s withdrawal from the European Union
The European Commission recently published a communication which indicated that competent authorities may allow marketing authorisation holders, for a limited period of time subject to certain conditions, to rely on quality control testing performed in the United Kingdom (hereafter ‘the exemption’).
The HPRA would like to outline some key points relating to the process for applying for this exemption for human and veterinary medicines
27 February 2019 - Government publishes a further range of practical advice to help businesses and citizens get Brexit ready
While there is still a lot of uncertainty about how and when the UK will leave the European Union, it’s important for you to be aware of what Brexit may mean for your business and your daily life. The Government has today published a further range of practical advice on the gov.ie/brexit website. This content will be updated regularly as more information becomes available.
26 February 2019 - European Commission statement on the withdrawal of the UK and EU rules for batch testing of medicinal products
The European Commission has published (25 February 2019) a communication entitled Withdrawal of the UK and EU rules for batch testing of medicinal products.
In relation to quality control (QC) testing, the Commission has noted that there may be objective reasons beyond the control of marketing authorisation holders (MAHs) that may prevent timely transfer of QC testing to an EU/EEA site by the withdrawal date. The Commission letter outlines circumstances under which competent authorities may allow, by way of exemption, on-going release of medicines onto the EU market based on QC testing performed in the UK. Please note that these provisions are subject to conditions and will apply for a limited time period up until end December 2019 at the latest.
The Commission also outlines in this statement that a batch release site in the EU 27 will need to be identified by the MAH before 29 March 2019 so that on-going EU compliance can be assured post withdrawal.
Applications for an exemption must be submitted as soon as possible and in no case later than 29 March 2019. The HPRA is inviting companies who may wish to submit such an application to contact us as soon as possible for details of the procedure involved.
Companies are reminded that the MAH must be EU based as of 30 March 2019 and any outstanding MAH transfers must be urgently submitted to allow processing by the withdrawal date.
The HPRA remains available to discuss particular challenges presenting to stakeholders and in particular would welcome the opportunity to clarify any aspects of this exemption process with your Brexit representatives in the coming days. Please using the relevant e-mail address above.
18 February 2019 - Businesses urged to contact suppliers to ensure continuity of supply of goods and services post Brexit
According to the Minister for Business, Enterprise and Innovation, Heather Humphreys TD, “whether a business is a construction company, local beauty salon, bakery or even an Irish base of a multinational medical device company, it is crucial that they check their supply chains for vulnerabilities to Brexit impacts".
The Department of Business, Enterprise and Innovation (DBEI) website lists an extensive range of available supports and resources that are focused on Getting Business Brexit Ready. This includes advice from the European Commission on the seven things businesses need to know to prepare for Brexit. Businesses within the EU27 are encouraged to use this list to understand the impacts that Brexit is likely to have on their business, and to guide their preparations.
7 February 2019 - Preparing for Brexit: Advice for Irish-owned life sciences businesses
Enterprise Ireland has published a helpful article for Irish-owned life sciences businesses on the potential impact of Brexit. It is based on the advice and guidance provided by the HPRA to approximately 400 industry representatives who attended our recent Brexit stakeholder event.
The Enterprise Ireland Prepare for Brexit website has a wide range of supports, including online customs training and a range of helpful insights, to enable Irish businesses to take critical action and address their exposure to Brexit.
1 February 2019 - EU Commission publish updated Brexit Q&A on medical devices
On 1 February 2019, the EU Commission published a Q&A document to provide further information on the impact of a no deal Brexit on medical devices (and other products covered under the New Approach legislation).
This Q&A follows on form the Commission's 2018 notice to stakeholders and highlights some of the implications on certification, labelling, representation and supply in the event of no deal.
The latest Q&A provides examples of when goods are placed on the market and in the supply chain which clarifies the validity of certification from a Notified Body for example. It also provides some clarification from the EU Commission’s perspective on the transfer of Notified Body certificates.
The HPRA is continuing to work with the European Commission and other Member States in relation to medical devices issues arising from Brexit.
The HPRA encourages any patients, healthcare providers, notified bodies, distributors, manufacturers or their authorised representatives who have a specific question or concern about medical devices supply or other devices issues, in the context of a "no-deal" Brexit, to contact us on firstname.lastname@example.org or the medical device department directly on +353 1 634 3453.
EU Commission Q&A
EU Commission Notice to Stakeholders January 2018
1 February 2019 - EU Commission and EMA publish updated Brexit Q&A for human and veterinary medicines
The EU Commission and EMA have today published an updated list of questions and answers related to the United Kingdom's withdrawal from the EU. The focus of this Q&A is on the regulation of medicinal products for human and veterinary use within the framework of the Centralised Procedure.
Significantly, the latest Q&A confirms that dual UK and Irish labels are acceptable where the labels meet the requirements of the Directive and reflect the SPC in Ireland. See Question 24 for further details.
The websites of the Commission and of the European Medicines Agency provide additional information. For products authorised in decentralised or mutual recognition procedures, additional information is available through the websites of the Coordination Groups – the CMDh and the CMDv. These pages will be updated with further information, where necessary.
30 January 2019 - Oireachtas Joint Committee on Health
Representatives from the Department of Health, the HSE and the HPRA appeared before the Joint Committee on Health on Wednesday, 30 January to discuss ‘Preparedness of the Health Sector for Brexit’. A key area of focus for the Committee was on the continuity of supply of medicines in the event of a 'no-deal' Brexit. The Secretary General of the Department of Health, Jim Breslin, outlined the significant work that has already taken place and the ongoing initiatives to minimise and address any risks to continuity of supply.
The Secretary General's Opening Statement to the Committee can be found on the Department's website. You can also view the full meeting on the Houses of the Oireachtas website.
25 January 2019 – Planning for a “No-Deal” Brexit
The HPRA is actively planning for a “no-deal” Brexit. Our goal is to support companies be ready for such an outcome on 29 March 2019.
Our key objective is to ensure protection of public and animal health by facilitating continued access to medicines in the event no deal is reached.
In respect of regulatory matters:
- We continue to encourage any company, MAH or manufacturer who identifies that they may have a regulatory issue to engage with so that we can seek to provide pragmatic regulatory solutions;
- We have already made it clear that we will continue to accept joint labels with the UK where those labels are appropriate for the Irish market.
- We are preparing a matrix of the regulatory requirements and considering how these might be addressed in a “no deal” scenario.
- We are reviewing supply chain and stock levels in Ireland, engaging with customs and reviewing specialist products that may be exposed to Brexit.
- We will utilise our existing shortages framework to work with all relevant stakeholders to manage any unavoidable short term delays arising from Brexit.
We continue to call on companies:
- To engage with the HPRA at the first opportunity if they believe that Brexit may impact on their ability to supply a human or veterinary medicines to the Irish market.
- Not to take a unilateral decision to cease supply to the Irish market based on regulatory issues without talking firstly to us at the HPRA.
- To review their supply chains to ensure they are robust, that the logistic companies can manage new custom requirements and that consideration of the requirements of the transiting protocol are considered and understood for those products transiting the UK.
25 January 2019 – "Getting Ireland Brexit Ready" website
On this site, you can find information about the Government’s most recent engagements, outreach events, and ongoing consultation work on Brexit. You can also find details of the resources and financial supports available from all Government Departments and Agencies to help businesses to prepare for Brexit. In addition, there is a comprehensive Frequently Asked Questions sections and access to key documents published by the Government outlining Ireland's negotiation strategy and preparations for the potential impacts of Brexit.
You can also subscribe to receive the Government Brexit Update newsletter. This newsletter service will allow you to receive the most reliable and up-to-date information, and gain greater insight into the steps the Government is taking to prepare for Brexit.
17 January 2019 – Preparations regarding the Supply of Medicines and Brexit
The Department of Health has published a short video which outlines the comprehensive and coordinated set of preparations to ensure the continuity of health services and supply of medical products in the event of a no-deal Brexit. This work involves the Department of Health, the HSE, the Health Products Regulatory Authority (HPRA) and other agencies engaging in intensive Brexit preparedness and contingency planning.
Further information is also available on the Department’s dedicated Brexit webpage.
14 January 2019 – Brexit Stakeholder Event on Friday, 1 February
The HPRA wishes to engage with industry stakeholders to outline the activities which the organisation is undertaking, to hear from them in respect of their ongoing preparatory actions and to discuss any regulatory matters and topics of mutual concern.
The meeting, which takes place on Friday 1 February, will focus on medicines for human and veterinary use as well as medical devices and will include short presentations from speakers, followed by an open forum to allow questions, identify areas of concerns and share information.
Further event Information including registration details