Part 2: Human Medicines Chapter 1: Regulations Section 2: Power to make regulations about human medicines
Section 2(1) confers a delegated power to amend or supplement the law relating to human medicines by regulations.
	The "law relating to human medicines" is defined (in section 9) to include four pieces of legislation only, namely:
the Human Medicines Regulations 2012 which provides the comprehensive regulatory structure under which human medicines are regulated;
the Medicines for Human Use (Clinical Trials) Regulations 2004 which regulate trials of human medicines involving humans;
the Medicines Act 1968 (specified provisions only) which regulates pharmacies; and
the Medicines (Products for Human Use) (Fees) Regulations 2016.
	Any amendments to this listed legislation will be captured by this definition, meaning this definition will always include the latest version.
	The power only allows for the existing legislative regime to be amended or supplemented. This means the power will be used to build on what is already there.
	The power is targeted in its scope because regulations made under it may only contain provision relating to the matters specified on the face of the Act at sections 3 to 7. The lists of matters specified in sections 3, 4, 5, 6 and 7 are exhaustive in each case, meaning that only regulatory changes that fall within these descriptions may be made under this power.
	Section 2(2) places a duty on the Secretary of State or Northern Ireland department making regulations (or both if acting jointly) to have the overarching objective of safeguarding public health when making regulations using the power under section 2(1).
	Section 2(3) provides that when considering whether regulations would contribute to the objective set out in section 2(2), the appropriate authority must at least have regard to the three factors set out at (a) to (c). These are the safety and availability of human medicines, and the likelihood of a relevant part of the UK (England, Scotland, Wales, or Northern Ireland) as being seen as a favourable place in which to carry out research relating to human medicines, to conduct clinical trials, and to manufacture or supply human medicines. Other factors may of course be relevant to any decision to exercise the delegated power.
	Section 2(4) provides that the appropriate authority may make regulations under section 2(1) that may have an impact on the safety of human medicines only if the authority considers that the benefits of doing so outweigh the risks.
	The delegated power is conferred on the "appropriate authority". In relation to England, Scotland and Wales, the "appropriate authority" is the Secretary of State. "Secretary of State" is defined in the Interpretation Act 1978 (c.30) to mean any Secretary of State but in practice it would be the Secretary of State for Health and Social Care exercising this power. In relation to Northern Ireland, the "appropriate authority" is the Department of Health in Northern Ireland acting alone, or the Secretary of State and the Department of Health in Northern Ireland acting jointly.