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Statutory Instruments
MEDICINES
Made
29th May 2024
Coming into force in accordance with regulation 1(2)
The Secretary of State in relation to England and Wales and Scotland and the Department of Health in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland make these Regulations in exercise of the powers conferred by sections 2(1), 3(1)(n), 3(2)(a), (c) and (d) and 43(2) of the Medicines and Medical Devices Act 2021(1) (“the Act”).
The Secretary of State and the Department of Health in Northern Ireland have carried out a public consultation in accordance with section 45(1) of the Act.
In accordance with section 2(2) to (4) of the Act, the Secretary of State’s and the Department of Health in Northern Ireland’s overarching objective in making these Regulations is safeguarding public health. The Secretary of State and the Department of Health in Northern Ireland have had regard to the matters specified in section 2(3) of the Act and consider that, where these Regulations may have an impact on the safety of human medicines, the benefit of making these Regulations outweigh the risks.
In accordance with section 47(3) and (6)(c) of the Act, a draft of this instrument was laid before Parliament and the Northern Ireland Assembly and approved by a resolution of each House of Parliament and the Northern Ireland Assembly.
2021 c. 3. The powers in section 2(1) of the Act and the provisions that relate to it are exercisable by the “appropriate authority”. As defined in section 2(6)(a) of the Act, the appropriate authority for England and Wales and Scotland is the Secretary of State. In relation to Northern Ireland, as defined in section 2(6)(b)(ii), the appropriate authority can mean the Secretary of State and the Department of Health in Northern Ireland acting jointly.
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