The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
Title and introductory text
2025 No. 87 Medicines The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 Made 23rd January 2025 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, (“the appropriate authority”), make the following Regulations in exercise of the powers conferred by sections 2(1), 3(1)(a), (d), (e), (h) to (j), 5(1)(b), (d) and (e) and 43(2)(a), (b) and (d) of the Medicines and Medical Devices Act 2021 (“the Act”). The appropriate authority has 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 appropriate authority’s overarching objective in making these Regulations is safeguarding public health, and the appropriate authority has had regard to the matters specified in section 2(3) of the Act and considers that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks. In accordance with section 47(3) and (6)(c) of the Act, a draft 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.
Title and introductory text
2025 No. 87 Medicines The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 Made 23rd January 2025 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, (“the appropriate authority”), make the following Regulations in exercise of the powers conferred by sections 2(1), 3(1)(a), (d), (e), (h) to (j), 5(1)(b), (d) and (e) and 43(2)(a), (b) and (d) of the Medicines and Medical Devices Act 2021 (“the Act”). The appropriate authority has 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 appropriate authority’s overarching objective in making these Regulations is safeguarding public health, and the appropriate authority has had regard to the matters specified in section 2(3) of the Act and considers that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks. In accordance with section 47(3) and (6)(c) of the Act, a draft 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.
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