News Category: Regulatory news
At the end of March this year, the United Kingdom (UK) notified the European Council that it intends to withdraw from the European Union (EU). Together with other Member States and the European Medicines Agency (EMA), the HPRA is making preparations to ensure that we continue to deliver on our patient and animal health remit even if the UK fully exits the current systems on 29 March 2019.
The UK continues to play a full role within the European regulatory network during the ongoing discussions in relation to its withdrawal from the EU. Although the eventual outcomes of these negotiations are unknown, there are potentially significant implications for the European network as a whole and particularly for Ireland with its shared market place.
Protecting the availability of medicines for Irish patients and the integrity of our market are key strategic aims of the HPRA’s Brexit-related activities while also optimising our role within the European regulatory network and maintaining our strong working relationships with UK colleagues. In relation to veterinary medicines, the HPRA recognises the particular challenges facing Irish agriculture and the impact of Brexit on the availability of veterinary medicines in Ireland. The HPRA is committed to increasing its contribution to the EU network through assessment of centralised and decentralised marketing authorisation applications, being available to carry out inspections and expanding its role in medical devices.
The HPRA has established an internal working group under the direction of Rita Purcell, Deputy Chief Executive, to ensure that we are prepared for the UK’s withdrawal from the EU. The HPRA will provide information on this page to keep stakeholders informed of developments. Companies should check this page regularly for further guidance and updates.
Proposed stakeholder meeting
The HPRA intends to hold a stakeholder meeting to engage with stakeholders on our approach to potential Brexit scenarios and to understand the concerns and requirements of different stakeholder groups. This meeting, which will focus on medicines for human and veterinary use, will take place on the afternoon of 31 August 2017 at the Crowne Plaza in Santry, Dublin, starting at 13.30. We will have short presentations from HPRA, industry and other state agencies, followed by an open forum to allow questions, identify areas of concerns and share information.
A link to the registration website will be available shortly. Any questions or areas of concerns can be submitted in advance to customerservices@hpra.ie.
Ensuring market availability
A major priority for the HPRA is to ensure the availability and the continued uninterrupted supply of human and veterinary medicines and medical devices in Ireland. The HPRA will provide support to marketing authorisation holders (MAHs) so as to maintain the availability of medicines and is available to meet with and discuss issues with MAHs, as required.
To assist with this the HPRA has requested MAHs which hold a marketing authorisation in Ireland for a medicinal product for human use, where the UK is the RMS or a CMS, to respond to a survey. The survey seeks to identify any products where supply and availability may be interrupted in the event of the UK withdrawing from the EU and to ensure that plans are in place to proactively address this. The HPRA would like to thank MAHs who have already submitted their responses to this survey and to ask those who have not yet submitted their responses to submit them as soon as possible to article50changes@hpra.ie.
MAHs which hold a marketing authorisation in Ireland for a veterinary medicine, where the UK is the RMS, have also been surveyed to ascertain the likelihood of products being withdrawn from the market and MAHs’ preferences with respect to products that are currently marketed in joint packaging for the Irish and UK markets.
Increasing our share of regulatory workload
Recognising the considerable contribution currently made by the UK to the work of the European medicines network, the HPRA is ready to assume a greater role in EU regulatory activities post-Brexit as may be required. The EMA has established working groups to operationalise agreed principles and rules for re-distribution of the centralised workload, see EMA: United Kingdom’s Withdrawal from the European Union (Brexit’). The CMDh has also published information for marketing authorisation holders of nationally authorised products; see CMDh: information on Brexit. Similar information from the CMDv will be published shortly on the HMA website.
The HPRA already plays a significant role in the European Medicines regulatory network. Our representation in the EMA’s committees and working parties mirrors that of the larger agencies in Europe. Our colleagues are highly regarded, holding leading positions including chair of the Committee for Medicinal Products for Veterinary Use (CVMP) and vice-chair of the Pharmacovigilance Risk Assessment Committee (PRAC).
We have a strong profile in terms of assessment work, ranking in the top 2 in the veterinary medicines assessments over the past 10 years and ranking in the top 10 in Europe for human medicines post authorisation work. Our inspection activities are recognised as providing a strong regulatory environment in Ireland and are heavily relied on for inspection of sites on behalf of the EMA.
The HPRA is fully committed to further increasing its contribution, particularly in the area of human and veterinary medicines assessments. We have already begun to plan for this, including identifying the need for increased resources, which is supported by the Department of Health and Department of Agriculture, Food and the Marine.
Companies wishing to discuss any aspect of their operations related to the UK’s withdrawal from the EU should submit their queries to customerservice@hpra.ie clearly indicating whether the query relates to human medicines, veterinary medicines or inspections.