No-Deal Brexit: How Medicines and Devices Will be Regulated in the UK
Posted 03 September 2019 | By
Although there may be another extension to Brexit day, the prospect for a no-deal Brexit at the end of October still looms large and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reiterated guidance on what will happen to drug and medical device regulations if such a no-deal path moves forward.
On the side of minimal disruption, MHRA notes that transitional legislation will ensure that all currently granted Centrally Authorised Products (CAPs) will automatically become UK marketing authorisations (MAs) on exit day. Similarly on the device side, the UK will have a system in place that mirrors all the key elements contained in the EU medical devices regulation (MDR) and in vitro diagnostic regulation (IVDR) and which will be brought into force in line with the transitional timetable currently being followed by the EU (dates of application are in May 2020 for MDR and May 2022 for IVDR).
The UK also said it will realign with the EU’s new clinical trials regulation when it takes effect.
But MHRA will also have much more on its plate in a post-Brexit world. For instance, currently, risk management plans, reports of suspected adverse drug reactions from the pharmaceutical industry, the majority of periodic safety update reports (PSURs) and post-authorisation safety studies (PASS) are submitted and assessed at the EU level. But after Brexit, these will need to be submitted to and assessed by MHRA. The regulator will also take over the system for pediatric investigation plans and control determining how orphan medicines are designated.
In some cases, drug and device firms will need to provide MHRA with more information and data to stay on the market in the UK.
For instance, CAP Marketing Authorisation Holders (MAHs) will have one year from exit day to provide MHRA with baseline data for CAPs that are converted into UK MAs. MAHs also will have a short period of time after exit day to opt out of having a UK MA. And by 31 July 2021, MAHs will need to establish a legal presence in the UK and have a qualified person for pharmacovigilance.
MHRA also will give industry until the end of 2021 to amend certain administrative details on the packaging and in the package leaflets for a product already on the market.
On the device side, companies manufacturing devices, active implantable medical devices, in vitro diagnostics (IVDs) and custom-made devices will be allowed grace periods of between four and 12 months to allow time for compliance with the new registration process with MHRA.
Sponsors will also have to submit all UK-relevant serious adverse events to MHRA.
As far as clinical trials, many of the existing rules will remain, although the UK is also planning its own public database to provide UK patients and researchers a single reference point for all UK-based trials.
In addition to the no-deal Brexit guidance, MHRA also has published more than 30 other documents to provide further guidance for industry.
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
MHRA guidance and publications about a possible no-deal Brexit