The Secretary of State makes these Regulations in exercise of the powers conferred by sections 10(1), 11, 12(1)(a), (b) and (c), and 43(2) of the Medicines and Medical Devices Act 2021() (“the Act”).
In accordance with section 10(2) of the Act, the Secretary of State’s overarching objective in making these Regulations is to promote one or more of the matters specified in that subsection.
The Secretary of State—
(a)has had regard to the matters mentioned in paragraphs (a), (b) and (c) of section 10(3) of the Act; and
(b)considers that, in accordance with section 10(4) of the Act, the benefits of making these Regulations outweigh the risks.
The Secretary of State has consulted in accordance with section 45(1) of the Act and has set out in the consultation document, in accordance with section 45(3) of the Act, a summary of the Secretary of State’s assessment of the matters mentioned in section 10 of the Act.
A draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament in accordance with section 47(3) and (6)(a) of the Act.