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1. These Regulations may be cited as the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and come into force immediately before IP completion day.
2. In the Good Laboratory Practice Regulations 1999(1)—
(a)omit regulation 5(4)(b) (and the “or” at the end of sub-paragraph (a)), and
(b)in regulation 6(4), omit “unless, in order” to the end.
3. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019(2) are amended in accordance with Schedule 1.
4. The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019(3) are amended in accordance with Schedule 2.
5. The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019(4) are amended in accordance with Schedule 3.
Signed by authority of the Secretary of State for Health and Social Care
Edward Argar
Minister of State,
Department of Health and Social Care
3rd December 2020
We consent
Maggie Throup
Rebecca Harris
Two of the Lords Commissioners of Her Majesty’s Treasury
8th December 2020