Part 2: Human Medicines Chapter 1: Regulations Section 4: Falsified medicines
Section 4 sets out two matters that regulations made under section 2(1) may be used to address. The first provides that regulatory provisions may be made about the prevention of the supply of falsified medicines. The second, provides that provisions can be made about the use, retention and disclosure of information held within a possible future falsified medicine prevent system for any additional purpose to do with human medicines.
	Falsified human medicines are defined in section 9, by reference to regulation 8 of the HMRs, as human medicines that represent falsely their identity (including packaging, naming or composition), source or provenance.
	Subsection (2) sets out a framework for preventative measures that regulations made under subsection (1)(a) may include. Subsection (2)(a) provides what regulation made under section 2(1) and relying on clause 4(1)(a)) may include, i.e. rules around the inclusion of unique identifiers and anti-tamper devices on packs of authorised human medicines in order to allow the identity and authenticity of individual packs to be verified.
	Subsection (2)(b) allows provision to be made for checks to be carried out relating to these packs and ensuring all medicines in scope include a unique identifier and anti-tamper device.
	Subsection (2)(c) provides that provision can be made in relation to the infrastructure, systems and processes around these checks, including who should set up, pay for and maintain any necessary systems.
	Subsection (3) sets out a duty to have regard to the importance of ensuring that information that is collected for the purpose of the prevention of the supply of falsified medicines is retained securely. This duty applies to provisions made in reliance of clause 4(1)(a) and (b).