Medicines and Medical Devices Act 2021

2 Power to make regulations about human medicines

(1) The appropriate authority may by regulations make provision specified in sections 3 to 7 amending or supplementing the law relating to human medicines.

(2) In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.

(3) In considering whether regulations under subsection (1) would contribute to this objective, the appropriate authority must have regard to—

(a) the safety of human medicines;

(b) the availability of human medicines;

(c) the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to—

(i) carry out research relating to human medicines,

(ii) conduct clinical trials, or

(iii) manufacture or supply human medicines.

(4) Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

(5) In subsection (3)(c), “relevant part of the United Kingdom” means—

(a) so far as the regulations relate to England and Wales and Scotland, those parts of the United Kingdom, and

(b) so far as the regulations relate to Northern Ireland, that part of the United Kingdom.

(6) In this Part, “appropriate authority” means—

(a) in relation to England and Wales and Scotland, the Secretary of State, and

(b) in relation to Northern Ireland—

(i) the Department of Health in Northern Ireland, or

(ii) the Department of Health in Northern Ireland and the Secretary of State acting jointly.