101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 144 Medical: Regulations: Information Submission Purpose The purpose of this notice is to inform MHRA (Medicines and Healthcare Products Regulatory Agency) stakeholders of what they’ll need to do to continue to submit regulatory information to us in the unlikely event of a no-deal scenario. Interested parties may wish to consider other relevant notices, including ‘ 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 ’. Before 29 March 2019 We’re currently a part of the EU regulatory networks for medicines and medical devices. These regulatory networks have shared processes and systems. You can submit information into one place for it to be shared around all EU and EEA countries. The shared systems, in the case of human medicinal products, include, but are not limited to:  CESP (common European submission portal)  EMA (European Medicines Agency) gateway  EudraVigilance  Common repository  PSUR (periodic safety update report) repository  PedRA (paediatric record application)  EudraCT and the new CTR (clinical trial regulation) portal  Article 57 database  EudraLink and EudraMail For medical devices, shared systems include, but are not limited to, the European Databank for medical devices (EUDAMED). Shared systems also exist for other products, such as the EU common entry gate (EU-CEG) for tobacco products, e-cigarettes and refill containers. After 29 March 2019 if there’s no deal If there’s no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. The sharing of these common systems, and the associated exchanges of data, between the UK and EU/EEA countries would end. We would have our own processes and systems to manage UK human medicines and devices regulatory activities. To do this, some new systems are being developed for March 2019. Implications for MHRA stakeholders You would need to submit regulatory information relating to human medicines and devices directly to us. We would have a national portal(s) for you to submit regulatory information into. The following types of information would be submitted via a portal (not an exhaustive list):  marketing authorisation (MA) applications  periodic safety update reports (PSURs)  paediatric investigation plans (PIPs)  clinical trial applications  qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) notifications  individual case safety reports (ICSRs) and subsequent transmission of anonymised single patient reports (ASPRs)  device registration  e-cigarette notifications. For applications that you plan to submit to both the EU and the UK (for example, a MA for both EU and UK markets), you would need to submit the information separately through EU systems and our portals.