Brexit and the Regulation of Health Products – Latest Information

The United Kingdom left the European Union on 1 February 2020 after both sides concluded a Withdrawal Agreement to facilitate an orderly departure. The Withdrawal Agreement also provides for a transition period. The transition period is intended to give time for national administrations, businesses and citizens to get ready for the significant and enduring changes that will definitively arise on 1 January 2021 as a result of the UK’s decision to leave the EU.

Whether you’re a concerned citizen or wondering how Brexit may affect your business, visit the Government website gov.ie/brexit to keep up to date on the latest news and advice. This includes the Brexit Readiness Action Plan which sets out the steps that businesses and individuals need to take now, to be ready for the end of the Transition Period on 31 December 2020.

The HPRA will provide information on this dedicated section of our website to keep stakeholders informed of developments related to Brexit and the health products we regulate.

Download our Brexit Transition Period Checklist for medicines and medical devices.

Please see our detailed Brexit guidance document for human and veterinary medicines (last updated October 2020). You can also visit the dedicated Medical Devices Brexit page or Cosmetics page for relevant updates. Our additional background information relating to Brexit is also available.

The HPRA continues to advise companies to engage with us at the earliest opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market.

Companies can submit Brexit queries to the relevant e-mail address below:

Human Medicines – brexit@hpra.ie 

Veterinary Medicines – vetinfo@hpra.ie

Medical Devices – devices@hpra.ieCosmetics –cosmetics@hpra.ie