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Citation and commencement

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.

Amendment of the Good Laboratory Practice Regulations 1999

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.

Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

3.  The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019(2) are amended in accordance with Schedule 1.

Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

4.  The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019(3) are amended in accordance with Schedule 2.

Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

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