Human medicines - existing regulatory regime
The regulatory regime for human medicines in the UK is based on the EU Human Medicines Directive 1   and is set out in the Human Medicines Regulations 2012 ("the HMRs"). The regime provides a comprehensive scheme for regulating human medicines that covers their licensing, manufacture, importing, brokering, labelling, distribution, advertising and pharmacovigilance (safety monitoring), amongst other things. The scheme is overseen by the UK licensing authority which consists of the Secretary of State (for Health and Social Care) and the Minister of Health in Northern Ireland. In practice, the scheme is overseen by the Medicines and Healthcare products Regulatory Agency ("the MHRA") acting on behalf of the Secretary of State.
	The MHRA is an executive agency of the Department of Health and Social Care. It operates as a trading fund which means that it has a degree of financial autonomy but it does not have a separate legal personality from the Department.
	As well as transposing the EU Medicines Directive into UK law, the HMRs contain some provisions on matters that relate to human medicines, but which fall outside EU competence and hence are a matter of national policy. In particular, the HMRs create a framework around the supply of human medicines to the patient, for example who may prescribe prescription-only medicines, who may supply them and the circumstances in which non-prescription medicines may be supplied, including in all cases multiple exceptions.
	The Medicines (Products for Human Use) (Fees) Regulations 2016 (SI 2016/190) makes provision for the fees payable in relation to the regulation of human medicines.
	The Medicines Act 1968 (c.67) also contains some national provision that relates to human medicines. It contains the provisions that regulate pharmacies and pharmacists in relation to supplying human medicines which is also a matter that falls outside EU competence.