UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit
The UK government has published three pieces of draft legislation, covering the regulation of medicines, medical devices and clinical trials, as part of its contingency planning in the event of a no-deal Brexit.The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said, “Contingency legislation is needed” for the agency “to be able to take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency (EMA) and other bodies.” The regulations “are subject to approval by Parliament and were laid in Parliament this week,” MHRA added.
The move comes as Britain’s 29 March exit from the European Union without an agreement on continuing resolutions became increasingly more likely, though a delayed exit remains an option. It also follows on the heels of MHRA’s further guidance on no-deal Brexit preparations for drugs and devices.
The draft legislative pieces seek to safeguard the future landscape for MHRA’s continued regulation of medicinal products in the UK market by tweaking certain existing regulations, such as to allow centrally authorized products to be grandfathered into UK marketing authorizations post Brexit.
On medical devices, the draft legislation includes provisions for the introduction of the UK’s version of the European medical device and in vitro diagnostic regulation (MDR/IVDR) into law by 2020 and 2022.
The MHRA regulations proposed in the pieces of draft legislation also cover other areas in the drug and device sectors, such as importation, distribution, sales, supply and advertising, among others.
Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
The Medical Devices (amendment) (EU exit) Regulations 2019
The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019