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BETA

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Publication

Healthcare, Medicines & Medical Products

Published: 9 September 2019
From: Department of the Taoiseach

Brexit will have implications for the life sciences and healthcare sectors in Ireland, particularly in relation to supply chains and regulatory requirements.

There are a number of steps that healthcare providers, manufacturers and wholesalers can and are taking to minimise any impact on their operations.

Continuity of supply

Government has been working with the sector to ensure continuity of supply and Ireland is unlikely to face general medicines supply issues in the period immediately post-Brexit, even in a no deal scenario. Any emerging supply issues will, in the first instance, be dealt with from existing supplies held within the domestic distribution chain.

Based on engagement with industry, Government has advised that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines ahead of Brexit. To do so, could disrupt existing stock levels and hamper the supply of medicines for other patients.

The supply chain for medicines is complex. Shortages are a feature of the global medicines landscape faced by all countries on an ongoing basis. In 2018, a multi-stakeholder Medicine Shortages Framework was put in place to mitigate the impact of such shortages when they occur.

As an additional safeguard, special consideration is being given to those categories of medicines considered most essential to public health. The HSE and the Health Products Regulatory Authority (HPRA) are working with key stakeholders to further assess key risk areas and to focus contingency planning efforts on potentially vulnerable medicines. They are seeking additional assurances from suppliers, verifying contingency planning and, where necessary, identifying clinically appropriate alternatives. This will ensure, insofar as is possible, continuity of care for patients in Ireland. The continued engagement and cooperation of stakeholders is appreciated.

The HPRA continues to advise suppliers to engage at the earliest opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market. Suppliers are asked to contact the HPRA regarding any issues or concerns by emailing info@hpra.ie or calling +353 1 676 4971.

Supply chain, customs and logistics

There are approximately 4,000 medicines marketed in Ireland, a substantial proportion of which come from, or travel through, the UK. The key risk to medicine supply from a no deal Brexit is potential delays at customs. However, companies have been engaging in extensive Brexit planning for the last two years and advanced arrangements are in place to ensure continuity of supply. Likewise, a high proportion of Ireland’s trade in medical devices is with or through the UK.

If you are a company that works in this area, please see further information on preparations regarding your supply chain, managing your transport and logistics and arrangements for trading with the UK post-Brexit.

Regulatory, certification and operational implications

Medicines and medical products are highly regulated products. There are a number of EU and national regulations in place to ensure high product standards and safety. When the UK leaves the EU, there will be regulatory and operational impacts for medicines and medical devices that are wholly- or part- manufactured in the UK and/or which are regulated through UK authorities.

Medicines

The HPRA, the national competent authority for medicines, is supporting stakeholders in managing the regulatory and operational implications arising from Brexit. For further information, visit the HPRA .

In relation to labelling of medicines, the EU has confirmed that dual UK and Irish labels on medicines are acceptable where the labels meet the requirements of Directive 2001/83/EC. See Question 24 set out in the EU Commission Guidance on Medicinal Products for further details.

The European Commission has published updated information on batch testing of medicinal products. It outlines circumstances under which national competent authorities may allow, by way of exemption, on-going release of medicines onto the EU market based on quality control testing performed in the UK. These provisions are subject to conditions and will apply for a limited time period up until end December 2019 at the latest.

Applications for an exemption must be submitted as soon as possible. The HPRA is inviting companies who may wish to submit such an application to make contact as soon as possible. The HPRA is available to discuss and clarify any aspects of this exemption process.

Post-Brexit, companies exporting medicines to the UK may be subject to new or different regulatory requirements over time. Further detail can be found here . Companies will also have to ensure they comply with any new customs requirements that the UK may put in place. You are also advised to contact any professional bodies that you are a member of to see if they have additional advice on preparing for Brexit.

This website will be updated with new information as it becomes available.

Medical Devices

A high proportion of the certification processes for medical devices on the EU market are carried out by UK-based Notified Bodies. If the UK leaves the EU without a deal, these UK bodies will no longer have the authority to issue such certificates, and existing certificates may no longer be valid. This is an issue that affects all EU member states. Please see certification and licensing for further information.

Post-Brexit, companies exporting medical devices to the UK may be subject to new or different regulatory requirements over time. Further detail can be found here . Businesses are also advised to engage with any trade representative body of which they are a member and which can assist them in preparing for Brexit. Companies will also have to ensure they comply with any new customs requirements that the UK may put in place.

This website will be updated with new information as it becomes available.

Professional qualifications

Professional qualifications are specific qualification requirements that a person needs to possess by law in order to access or pursue a regulated profession or to engage in regulated activities, such as in healthcare, in a given country.

Post-Brexit, there may be implications for individuals working in Ireland or another EU Member State who obtained professional qualifications in the UK, or who seek to have a qualification recognised after UK withdrawal from the EU. However, if you have already had these qualifications recognised by the relevant regulator, there will be no change and you can continue to practise in Ireland or elsewhere in the EU.

The Government has encouraged regulatory authorities in Ireland to engage with their counterparts in the UK to manage the process of continued recognition. This website will be updated with any new information.

If you have a query about your professional qualification, you should contact the relevant regulatory body for your profession.

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Please see Government Programmes, Funds & Supports for the range of initiatives in place to support businesses to prepare for Brexit.

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