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Brexit and the Regulation of Health Products – Latest Information

The United Kingdom formally left the European Union on 31 January 2020. Following the end of the transitional period, the Trade and Cooperation Agreement – and the Protocol on Northern Ireland – was implemented on 1 January 2021. The HPRA continues to engage with all stakeholders to minimise the impact of Brexit and to ensure the supply of health products for the Irish market.

The HPRA has provided regular Brexit updates below in date order. You can also visit the dedicated Medical Devices Brexit page or Cosmetics page for relevant updates.

See the European Commission website for more information on the Trade and Cooperation Agreement.

Visit the Government website gov.ie/brexit for up to date on the latest news and advice.

Useful information for patients can be found on the HSE’s website.

Brexit Queries — Contacting the HPRA

For contact details for specific Brexit queries, please visit our Brexit Queries webpage.

6 December 2023 – Questions and Answers on the Windsor Framework

We have published a Q&A document relating to the impact of the Windsor Framework on the regulation of human medicines. The document is based on questions the HPRA has received from companies.

Further questions on this topic can be sent to brexit@hpra.ie. We will update the document as necessary.

25 May 2023 – The Windsor Framework and expiry of existing exemptions in December 2024

On 26 February 2023, the EU and the UK reached political agreement in principle on the Windsor framework. The parties to the agreement are committed to take “the necessary steps to translate the joint solutions into legally binding instruments and to implement these swiftly and in good faith”.

While the agreement covers trade generally, this update only focuses on human medicines.

See our news item for further information.

19 December 2022 — 2022 Brexit exemptions for veterinary medicines extended until 31 December 2025

The European Commission has announced an extension until 31 December 2025 of the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK. This allows companies and operators in Ireland, Northern Ireland, Cyprus and Malta to comply with EU law and prevent shortages of veterinary medicines, particularly on the island of Ireland.

The Commission had previously announced an extension until 31 December 2022. Marketing authorisation holders were expected to make necessary arrangements to comply with the EU legislation by that date. However, this has now been extended for a further final period until 31 December 2025.

Marketing authorisation holders that currently benefit from so-called ‘Brexit’ exemptions must engage with the national competent authorities to identify all relevant products. Later in 2023, the MAHs must provide a workplan charting how they plan to achieve full regulatory compliance with EU law within the timeframe given.

27 May 2022 — Products availing of a derogation under Directive 2022/642/EC (post-Brexit)

On 20 April 2022, Directive 2022/642/EC of the European Parliament entered into force. This Directive amends Directives 2001/20/EC and 2001/83/EC regarding derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, and in Cyprus, Ireland and Malta. The objectives of amending Directive 2022/642/EC are to facilitate continued supply of medicinal products and to maintain a high level of public health protection. In order to ensure uniform application of Union law in all Member States, the derogations applicable in Cyprus, Ireland and Malta will apply until 31 December 2024.

To ensure transparency, the Directive stipulates that the competent authorities of Cyprus, Ireland and Malta and the United Kingdom in respect of Northern Ireland publish on their website a list of the medicinal products marketed to which these derogations have been granted.

The HPRA has compiled the list of products availing of the derogations as permitted in Directive 2022/642/EC. Products are identified by product name, PA number and MAH. This list is required to be updated on at least a six-monthly basis.

MAHs to whom derogations have been granted are required to check the details of this list below and to contact the HPRA at brexit@hpra.ie when a particular derogation is no longer required, specifying which derogation is no longer needed. When full regulatory compliance has been achieved, please contact the HPRA and the product can be removed from the list.

Forms

Applicants must fill in a justification template outlining their request for a justifiable case, in order to proceed with a variation/new application which includes a UK (GB) site on a licence. Where the HPRA agrees to such a justification, the HPRA will revert with the completed template which must then be included by the applicant in their submission to the RMS (in Module 1).

After approval of the relevant new application/variation procedure and at the time of marketing of the new product in IE or for existing products, a second step is required to formally request a derogation from the HPRA and to include this product on the published list held by the HPRA.

*These forms were published on 14 June 2022.

17 December 2021 — Extension of derogations for human and veterinary medicinal products impacted by Brexit

The European Commission has put forward proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address outstanding supply concerns in Ireland, Cyprus and Malta. The existing derogations for human and veterinary medicinal products impacted by Brexit will be extended until the end of 2022, or until a legislative proposal is put in place.

Please see further information here.

25 May 2021 — EU and UK Trade and Cooperation Agreement: Summary of Annex on Technical Barriers to Trade (TBT) 2 on Medicinal Products

The EU and UK Trade and Cooperation Agreement (TCA) was published on 24 December 2020. The TCA includes an Annex for human and veterinary medicinal products, which sets out the conditions for the recognition of Good Manufacturing Practice (GMP) inspections between regulatory authorities in EU Member States and the United Kingdom.

Below are some key summary points from Annex TBT – 2 on medicinal products:

The UK and the EU will recognise GMP inspections at manufacturing sites carried out by either party in their jurisdictions and in third countries.
Following a request for GMP documentation, each party shall endeavour to transmit the document within 30 calendar days of the date of the request.
Under specific circumstances, each party may opt not to accept an official GMP document issued by the other party’s authority.
Each party has the right to conduct its own inspection of manufacturing facilities that have been certified as compliant by the other party.
Each party shall notify the other party at least 60 days before adopting any new measures or changes relating to GMP, concerning any of the relevant laws, regulations and technical guidelines.
As a result of any of the new measures or changes, a party can consider that it can no longer recognise inspections or accept official GMP documents issued by the other party and the parties shall enter into consultations within the relevant working group on medicinal products.
Each party has the right to suspend totally or partially the recognition of inspections of the other party for all or some of the products.
The parties shall cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines.
The relevant working group on medicinal products shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation and ensuring the proper functioning of this Annex.

17 May 2021 — Reference medicinal products: updated CMDh guidance

As the Brexit transition period has now ended, the CMDh has published updated guidance on reference medicinal products (RefMPs) in the latest version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (Feb 2021).

The Practical Guidance, in particular its Annex on Medicinal Products, aims to provide procedural and practical guidance and addresses the implications of the Withdrawal Agreement and the Trade and Cooperation Agreement between the EU and UK.

Specifically, for issues relating to RefMPs, the HPRA wishes to draw your attention to the responses to Questions 34 and 39 of the guidance document.

Guidance on dealing with new DCPs and variations that are cross-referring to UK marketing authorisations for product information alignment is addressed in the response to Q39, and also included in Section 4.1 of the CMDh minutes, January 2021.

For new marketing authorisation applications a European reference product (ERP) should now be used, unless the exceptional case outlined in Q34 of the CMDh Brexit guidance arises. However, for ongoing generic new applications, while the UK ERP may be kept as being the RefMP of the original application, the applicant should align the product information to a suitable RefMP within the global marketing authorisation.

Details of variation classifications are included in the CMDh minutes, which also highlight the need to keep product information up to date.

The choice of RefMP is the responsibility of the applicant / MAH and the HPRA cannot provide specific advice. General reference medicinal product related queries can be submitted to submissions@hpra.ie.

21 January 2021 — Time-limited conditional exemptions to facilitate supply of medicines to the Irish market after Brexit

As outlined on the HPRA website on 1 January 2021, the European Commission has published a Notice on ‘Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period’.

This notice outlines that due to the historical dependence of Ireland, Malta, Cyprus and Northern Ireland on medicines supplied from Great Britain, in the exceptional cases where additional time is required to transfer certain functions to EU/EEA, and in the exceptional circumstance of a global pandemic, an additional period of up to one year (Jan 2021 to 31 Dec 2021) to comply with aspects of the Union’s acquis, has been agreed.

These exemptions, which are applicable for medicinal products and investigational medicinal products are outlined here.

In order for the MAH (which must be established in the Union) or EU-based sponsor/legal representative for a clinical trial, to apply for this time-limited conditional exemption, a request form must be submitted to the HPRA for the evaluation of your request (no later than 30 Jan 2021 where it relates to quality control (QC) testing).

Please see further information here.

14 January 2021 — Importing medicines and medical devices into Ireland from Great Britain

Brexit has resulted in substantial changes to the way in which medicines and medical devices are imported from Great Britain to Ireland.

We wish to remind you of the changed processes and to outline the key responsibilities that remain with the manufacturer / exporter / importer of the medicine or medical device. You must:

have oversight of your supply chain;
understand the new requirements applicable to product being imported from GB or being transported via the UK landbridge under the customs transit procedure;
liaise with your logistics’ companies and to be satisfied that appropriate arrangements are in place to manage the new customs requirements, and;
have oversight/ access to all necessary travel documents/ numbers such as the pre boarding notification (PBN) ID and / or Master Reference Number(s) (MRNs) so that any issues impacting on supply of critical medicines and medical devices can be resolved on a timely basis.

Detailed guidance in relation to Brexit and the associated customs requirements are available on the Revenue website.

For ease of reference, the HPRA has compiled information on some recent guidance issued by Revenue. Companies should ensure that they are familiar with all relevant guidance and are in a position to comply with any customs requirements relevant to their products.

01 January 2021 — Commission publishes notice on Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period

The European Commission has published a notice with details of the flexibilities that can be applied during 2021 to facilitate supply of medicines to named markets including Ireland. The HPRA has made further guidance on the operation of these flexibilities available here.

15 December 2020 — Updated Guidance for Medicinal Products Approved via MRP/DCP

The HPRA would like to inform stakeholders that the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP and the Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP have been updated/published on the CMDh website dated December 2020.

These documents reflect the current position for MRP/DCP products, and should be consulted in advance of submitting related Brexit queries to brexit@hpra.ie.

04 December 2020 - Article 41 of the Withdrawal Agreement: Medicines placed on the market before 11 pm on 31 December 2020

A medicine, which is certified by a Qualified Person and has been released in the United Kingdom (UK) for sale or supply before 11 pm on 31 December, can be supplied to the Irish market after the transition period ends. The receiving site in Ireland, which must be appropriately authorised (e.g. an authorised manufacturer or wholesaler), must perform checks on all shipments of medicine received to which the provisions of Article 41 apply.

In accordance with the Northern Ireland protocol, there will be no change to the existing regulatory requirements for the supply of batches of medicines, certified by a Qualified Person at a manufacturing site and released for sale or supply in Northern Ireland, to the Irish market.

Please visit our news article for full details.

02 December 2020 - EMA publishes questions and answers document on the implementation of the Protocol on Ireland / Northern Ireland for centrally authorised medicines

This questions and answers document provides additional practical guidance on the applicable rules in Northern Ireland after the transition period with respect to European Medicines Agency (EMA) activities and medicinal products for human and veterinary use within the framework of the centralised procedure.

The information complements the Notice to Stakeholders on the Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medical products and the EMA Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use (within the framework of the centralised procedure).

Further information can also be found on the EMA website.

20 November 2020 - Import of Tissues

As the UK will become a third country following Brexit, we would like to draw your attention to the fact that import of tissues into Ireland from outside of the European Union (EU), i.e. a third country, must only take place under an authorisation by the HPRA.

Three new guides have been published to provide further information to our stakeholders in relation to Brexit and tissues and cells. Please download the guides using the links below.

Brexit Guide for Stakeholders - Organisations Responsible for Human Application for Tissues and Cells - Dentists

Brexit Guide for Stakeholders - Organisations Responsible for Human Application of Tissues and Cells - Hospitals

Brexit Guide for Stakeholders - Tissue Establishments

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 cosmetics@hpra.ie.

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.

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?

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 cosmetics@hpra.ie.

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 devices@hpra.ie 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