Friday, 5 October 2018

MHRA to consult on EU exit no-deal legislative proposals


The Medicines and Healthcare products Regulatory Agency (MHRA) has today opened a consultation on how its legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period.

This consultation covers changes to four different Statutory Instruments (SIs): the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016. The changes to the latter two instruments are combined in a single SI.

The overall approach in the unlikely event of a no-deal scenario is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

Dr Ian Hudson, Chief Executive Officer at the MHRA said: "Our position on medicines and medical devices regulation remains clear. We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that.

I therefore strongly encourage anyone that has an interest to share their comments."

For further details, see MHRA

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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