PART 5

Regulations under Parts 1, 2, 3 and 4

Consultation
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1
Before making regulations under a provision of Part 1, 2, 3 or 4, the relevant authority must carry out a public consultation.
2
In relation to proposed regulations under section 19(1), the Secretary of State must specifically consult—
a
the Welsh Ministers,
b
the Scottish Ministers, and
c
the Department of Health in Northern Ireland.
3
In relation to proposed regulations under section 2(1), 10(1) or 15(1), the consultation document must include a summary of the relevant authority’s assessment of the matters mentioned in section 2, 10 or 15 (as the case may be).
4
The duty to consult imposed by subsection (1) does not apply in relation to regulations that contain only provision made in reliance on—
a
section 7 (disapplication of provisions relating to human medicines where there is a risk of serious harm to health), or
b
section 18 (disapplication of provisions relating to medical devices where there is a risk of serious harm to health),
where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health.
5
The duty to consult imposed by subsection (1) may be satisfied by consultation carried out before this Act was passed.
6
In this section, “the relevant authority” means—
a
in relation to regulations made under section 2(1) or 10(1), the appropriate authority within the meaning given by section 2(6) or 10(6) as the case may be, and
b
in relation to any other regulations, the Secretary of State.