Citation and commencement1

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 19992

In the Good Laboratory Practice Regulations 19992

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 20193

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 20193 are amended in accordance with Schedule 1.

Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 20194

The Human Medicines (Amendment etc.) (EU Exit) Regulations 20194 are amended in accordance with Schedule 2.

Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 20195

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 20195 are amended in accordance with Schedule 3.

Signed by authority of the Secretary of State for Health and Social Care

Edward ArgarMinister of State,Department of Health and Social Care

We consent

Maggie ThroupRebecca HarrisTwo of the Lords Commissioners of Her Majesty’s Treasury