The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019

These Regulations (which come into force immediately before exit day) are made to correct drafting defects and omissions in the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791). This is to ensure that the published policy in relation to the regulation of human medicines and medical devices in a no deal EU exit scenario is properly reflected in those instruments. Those instruments, which come into force on exit day, amend the Human Medicines Regulations 2012 (S.I. 2012/1916 – “HMRs”), associated Medicines (Fees) Regulations 2016 and the Medical Devices Regulations 2002 (S.I. 2002/618 – “MDRs”) to ensure they are fit for purpose in a no deal EU exit.

Sifting committees’ recommendation

The sifting committees disagreed with the government and recommended that this statutory instrument needs to be debated in parliament.

Statutory instrument

The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019

Explanatory memorandum

The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019-Explanatory Memorandum

Published 19 June 2019
Last updated 12 July 2019 + show all updates
  1. Both sifting committees have given their recommendation for this statutory instrument.
  2. First published.