Human and Veterinary Medicines

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, and through increasing our availability to carry out inspections.

Ensuring market availability

The HPRA’s priority, working with all relevant stakeholders, is to ensure continuity in the supply of health products and continued access for patients. It is therefore essential that all companies who require guidance and support to maintain their products on the market, contact the HPRA as soon as possible to effectively plan and prepare for the UK’s exit from the EU/European Economic Area (EEA).

It is the HPRA’s aim to support all stakeholders already present on the Irish market or stakeholders who may need to relocate from the UK to an EU/EEA country. Where feasible, we hope to provide pragmatic solutions to the anticipated regulatory challenges arising from Brexit.

In light of the pending withdrawal of the UK from the EU, we have published guidance in respect of the key issues facing the HPRA and our stakeholders. While there have been discussions at EU level on the introduction of transitional arrangements, the implementation and details of any transitional period will depend on the outcome of the Brexit negotiations.

As a result, the guidance provided in this document is based on the premise that there will be a hard Brexit and the UK will become a third country by 30 March 2019. It is also based on our current understanding of the potential legal impact of an exit by the UK. 

HPRA guidance document - Important information for stakeholders

It is highly likely that the advice currently provided may require updating throughout the negotiations process and during the lead up to Brexit. In addition, guidance is still being developed and must be agreed in respect of so-called ‘grey’ areas. Stakeholders are therefore advised to monitor our website on a regular basis to ensure they have access to the most up-to-date version of this document.

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 and CMDv have also published information for marketing authorisation holders of nationally authorised products.

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 clearly indicating whether the query relates to human medicines, veterinary medicines or inspections.

HPRA Brexit Seminar (August 2017)

The HPRA hosted a successful stakeholder seminar focused on the topic of Brexit on Thursday, 31 August 2017. The event, which was attended by close to 300 representatives from the biopharma, medtech and life sciences sector, reviewed and discussed the concerns of different stakeholder groups given the potentially significant implications of Brexit for the Irish market.