The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025

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 section 2(1), 6(1)(a) and 43(2) of the Medicines and Medical Devices Act 2021. 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 that Act. In accordance with section 2(2) to (4) of that 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, and the Secretary of State and the Department of Health in Northern Ireland have had regard to the matters specified in section 2(3) of that Act and consider that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks.