Submitting regulatory information if there’s no Brexit deal

The Department of Health and Social Care has released guidance to inform Medicines and Healthcare products Regulatory Agency (MHRA) stakeholders of how to continue to submit regulatory information in the event of a ’no-deal’ Brexit scenario. Further guidance on ‘Batch testing medicines if there’s no Brexit deal’ and ‘How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal’ should also be considered.

Information can currently be submitted into one place to enable it to be shared around the European Union (EU) and European Economic Area (EEA). With regards to human medicinal products, the shared systems include, but are not limited to: common European submission portal (CESP), European Medicines Agency (EMA) gateway, EudraVigilance, periodic safety update report (PSUR) repository, EudraCT and the new clinical trial regulation (CTR) portal.

After 29th March 2019, when the United Kingdom (UK) leaves the EU, if there is no deal then the UK would no longer be part of the EU medicines and medical devices regulatory networks. Therefore, the sharing of these common systems and the associated exchanges of data between the UK and EU/EEA countries would end. This means the MHRA would have to have their own processes and systems to manage UK human medicines and devices regulatory activities. New systems are currently being developed for March 2019 and the MHRA plans to provide communications and guidance on the new processes and systems ahead of March 2019.

If a no deal Brexit does occur then stakeholders would have to submit regulatory information directly to the MHRA. For example, the following types of information would have to be submitted via a national portal: marketing authorisation (MA) applications, periodic safety update reports (PSURs), clinical trial applications, qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) notifications, individual case safety reports (ICSRs) and device registration. For applications that require submission to both the EU and the UK, the information would need to be submitted separately through EU systems and the MHRA portals.

Further information and guidance regarding Brexit will be published in the coming months, and the MHRA is aiming to give businesses, organisations and individuals as much certainty as soon as possible to ensure that any new requirements are “not unduly burdensome”.

To read more about submitting regulatory information on medical products if there’s no Brexit deal, please click here.