HPRA making plans to deliver health remit

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 Healthcare Products Regulatory Authority (HPRA) is making preparations to ensure that they continue to deliver on their 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,” they say.

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.

Proposed stakeholder meeting

The HPRA intends to hold a stakeholder meeting to engage with stakeholders on their 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.

Visit www.hpra.ie for further details.

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. Those who have not yet submitted their responses should submit them as soon as possible to article50changes@hpra.ie.

Increasing 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 redistribution of the centralised workload, see EMA: United Kingdom’s Withdrawal from the European Union (Brexit’).

The HPRA already plays a significant role in the European Medicines regulatory network. Their representation in the EMA’s committees and working parties mirrors that of the larger agencies in Europe.

HPRA has 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. Their 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.

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