Marketing Authorisation Holders - Brexit Regulatory and Supply Preparedness – Human Medicines

News Category: Regulatory news

Date: 02/09/2019

The HPRA, in cooperation with the Department of Health and the HSE, has been engaged in extensive Brexit planning with stakeholders across the health sector. This is to ensure, to the fullest extent possible, that the necessary preparations for any adverse impacts as a result of the UK’s departure from the EU are completed.

We are in ongoing contact with companies across the pharmaceutical industry to once again highlight particular regulatory and supply matters linked to Brexit.

In respect of regulatory compliance, detailed information is included in our HPRA Brexit Guidance. This document highlights clearly the regulatory changes that companies need to implement in respect of issues such as the transfer of UK based marketing authorisations, batch testing and batch release. It is kept up-to-date to incorporate the most recent guidance from the European Commission, the EMA and the HMA. 

With regard to the supply of medicines, companies are requested to take the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading up to 31 October 2019 and post Brexit. This includes consideration of stocks at wholesale level and ensuring arrangements are in place to allow for timely replenishment of such stocks including custom requirements where applicable and allowing for potential delays during transportation.

Together with colleagues from the HSE, the HPRA continues to contact marketing authorisation holders to determine how both regulatory and supply matters relate to their product(s) marketed in Ireland, to request assurances in respect of their contingency planning, and to identify any potential issues regarding the availability of specific products associated with Brexit.

This iterative process has been ongoing for some time and will continue for the foreseeable future. This is in the context of the current assessment that there is a significant risk of a ‘no deal’ Brexit on 31 October 2019. The key goal of this review process is to focus contingency planning efforts on potentially vulnerable medicines and to ensure that appropriate actions have been taken by suppliers of those medicines to minimise and address any risks to continuity of supply.

We wish to acknowledge the substantial work completed to date by industry in respect of Brexit preparedness and look forward to ongoing cooperation. The HPRA remains available to discuss particular challenges presenting to stakeholders and to clarify any aspects as required.

It is absolutely critical that if you become aware of a Brexit-related issue that could potentially affect the supply of a medicine to Ireland that you inform the HPRA immediately by emailing

The Brexit section of our website will keep stakeholders informed of developments related to Brexit and the health products we regulate.

You can also view/download our Brexit Preparedness Checklist

Information for healthcare professionals and patients

Please note that no major supply concerns have been identified to date and no current medicines shortages are due to Brexit. As stock levels have been increased at wholesale level, and it is considered unlikely Ireland will face general medicines supply issues even in a ‘no deal’ scenario, there is no need for hospitals, healthcare professionals 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.

Brexit Preparedness Checklist

Brexit Preparedness Checklist

« Back