Q.01

What do the Human Medicines Regulations 2012 cover?

The Human Medicines Regulations 2012 (SI 2012/1916) are the main UK law on medicines for human use. They cover the whole life of a medicine: what counts as one, licensing to make and distribute it, marketing authorisation, pharmacovigilance, who may sell or supply it, packaging and leaflets, advertising, and enforcement. The instrument was made on 19 July 2012 and came into force on 14 August 2012 [1][2]. The revised text I read is up to date with changes in force on or before 5 October 2026. Some changes are still waiting to be added to the text, for example new regulations 4A and 220A inserted by S.I. 2025/1249 [1].

Approach: I read the latest revised text of the Regulations as published on legislation.gov.uk: the introduction, every regulation and all 45 Schedules. The Part titles below describe the regulation headings, because the full Part titles were not in what I retrieved.

Scope and key definitions (Part 1, regs 1-8)

  • What a "medicinal product" is (reg 2): any substance presented as preventing or treating disease in humans, or used to restore, correct or modify a bodily function by a pharmacological, immunological or metabolic action, or to make a medical diagnosis [3].
  • What is excluded (reg 2): the Regulations do not apply to whole human blood, or to blood components other than plasma prepared by an industrial process [3].
  • Other Part 1 provisions:
    • special scope rules and pharmacy exemptions (regs 3-4) [4][5];
    • the three classes of medicine: prescription only, pharmacy and general sale (reg 5) [6];
    • the licensing authority and the Ministers (reg 6) [7];
    • the meaning of "advertisement" (reg 7) [8];
    • general definitions (reg 8) [9].

What each Part covers

PartCoverage
2 (regs 9-16)The Commission on Human Medicines, the British Pharmacopoeia Commission and other advisory bodies [10]
3Manufacture and distribution: GMP and GDP (regs B17, C17) [11]; manufacturer's and wholesale dealer's licences and their conditions, including qualified persons [12][13]; brokering (regs 45A-45L) [14]; registration of importers, manufacturers and distributors of active substances (regs 45M-45V) [15]
4 (regs 46-47)The core ban on selling or supplying an unauthorised medicine. See the note below the table [16]
5 (regs 48-101)UK marketing authorisations and parallel import licences: applications, paediatric requirements and rewards, consideration of the application, validity, conditional authorisations, variation, suspension and revocation, holder obligations, urgent safety restrictions, and offences [17][18][19]
6 (regs 102-124)Certificates of registration for homoeopathic medicinal products [20][21]
7 (regs 124A-155)Traditional herbal registrations, including herbal monographs and the list of herbal substances and preparations [22][23]
8 (regs 156-158)Article 126a authorisations [24][25]
9 (regs 159-166)Provisional determinations, how to challenge them, and the written representations procedure [26]
10 (regs 167-176)Exceptions to the authorisation requirement, starting with supply to meet special patient needs ("specials") and NIMAR supply to Northern Ireland [27]
11 (regs 177-212)Pharmacovigilance: the duties of the licensing authority and of holders, record keeping and reporting, signal detection, PSURs, urgent action and major safety reviews, post-authorisation safety studies, additional monitoring, transparency, enforcement through infringement notices and offences, and transitional arrangements [28][29][30][31]
12 (regs 213-256)Sale and supply: prescription only, pharmacy and general sale medicines; supplementary prescribers; emergency supply by pharmacists; patient group directions; exemptions for specific substances (such as aspirin, paracetamol, pseudoephedrine and naloxone); restrictions on who may be supplied; disqualification [32][33][34][35]
12A (regs 256A-256ZA)Distance and online selling, including the notification requirements for sellers [36]
13 (regs 257-276)Packaging, safety features, package leaflets and child-resistant containers [37][38]
14 (regs 277-316)Advertising: general principles, advertising to the public and to health professionals, scrutiny of adverts by the Ministers, complaints, injunctions, and referral to OFCOM [39][40][41]
15 (regs 317-321)The British Pharmacopoeia, compendia and lists of names [42]
16 (regs 322-334)Enforcement in England, Wales, Scotland and Northern Ireland [43]
17 (regs 335-349)General rules on offences and defences, prosecutions, immunity from civil liability, review, and transitional provisions, including those for EU exit and the Windsor Framework (regs 347A, 347B) [44][45]

The core prohibition (reg 46): "A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product." A product counts as authorised only if one of these is in force for it: a UK marketing authorisation, a certificate of registration, a traditional herbal registration or an Article 126a authorisation. The rule is subject to the Part 10 exceptions [16].

Schedules

There are 45 Schedules. They contain the detailed requirements, including:

  • licence applications and standard licence provisions (Schs 3-4) [46][47];
  • qualified persons (Sch 7) [48];
  • what must accompany a marketing authorisation or parallel import licence application (Schs 8, 8A) [49][50];
  • variations to UK marketing authorisations (Sch 10A) [51];
  • patient group directions (Sch 16) [52];
  • packaging information and package leaflets (Schs 24, 27) [53][54];
  • particulars required in adverts to health professionals (Sch 30) [55];
  • EU exit and Windsor Framework transitional provisions (Schs 33A, 33B) [56][57];
  • amendments to existing law and repeals (Schs 34-35) [58][59].

Veterinary medicines are covered by the separate Veterinary Medicines Regulations 2013. Medical devices are covered by the Medical Devices Regulations 2002.

Q.02