101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 137 Medical: Medical Trial Regulation Purpose The purpose of this notice is to update businesses on the arrangements that will come into force for human medicines regulation currently subject to EU rules if we leave the EU on 29 March 2019 with no deal. The life sciences sector may also wish to consider other relevant notices, including o n Batch testing medicines if there’s no Brexit deal , Submitting regulatory information on medical products if there’s no Brexit deal . Other relevant notices will be signposted as they are published. The pharmaceutical sector may also wish to be aware that the Medicines and Healthcare Products Regulatory Agency (MHRA) is planning a consultation in early autumn, covering the regulation of medicines, medical devices and clinical trials. A more comprehensive technical notice covering the life sciences sector will follow after the consultation. Before 29 March 2019 Medicines Under the current EU membership, the UK is integrated in the EU medicines regulatory network (EMRN), including the European Medicines Agency (EMA). The EU legal framework for human medicines sets standards to protect public health and ensure medicines are safe and effective. The rules for marketing authorisation and monitoring authorised products are primarily laid down in Directive 2001/83/EC and in Regulation (EC) No 726/2004. In UK law, the Human Medicines Regulations (2012) (HMRs) set out a comprehensive regime for the authorisation of products, including their manufacture, import, distribution, sale and supply, as well as labelling, advertising and pharmacovigilance (monitoring the effects of medicines). The Medicines and Healthcare Products Regulatory Agency (MHRA) is our national regulator for human medicines (as well as medical devices, clinical trials and blood products). The EMRN manages some aspects of regulation including EU licensing procedures, pharmacovigilance and legal presence requirements. Medical Devices In the UK, all medical devices are subject to EU legislation, which use a CE marking to show compliance. Medical devices are regulated under three EU directives:  Active Implantable Medical Devices (AIMDD) (1990)  Medical Devices (MDD) (1993)  In Vitro Diagnostic Medical Devices (1998). Higher-risk devices (such as Class IIa, IIb and III medical devices and in vitro diagnostic devices in list A and list B in Annex II of the EU Directive, plus those for self-testing) must be certified by an independent conformity assessment body, called EU Notified Bodies (NB). EU NBs must be designated and overseen by their national authority (the MHRAin the UK), following joint audits by two other national authorities and the European Commission. Clinical Trials Clinical trials are managed nationally - in the UK by the MHRA. Some aspects of clinical trials are shared across the EMRN. For example, a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU/EEA. The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 (2004 Regulations). These regulations require all interventional clinical trials to be authorised by the MHRA and ethically approved. They also include requirements for the application and assessment, the supply of investigational medicinal products and safety reporting. The EU is planning to implement new regulations for clinical trials, which will further integrate clinical trial processes and requirements.