The Human Medicines Regulations 2012 (the regulations) is the main legislation in the UK covering the manufacture, importation, distribution, advertising, labelling, sale and supply of medical products for human use and pharmacovigilance (the monitoring of the effect and safety of medical drugs after they have been licensed for use).
The regulations amended, consolidated and repealed a significant number of prior laws in this area, and underpin much of the regulation of medicines in the UK.
In relation to the key areas covered by the regulations, these include:
- Manufacturing and wholesale dealing (grant of licenses) (Part 3) – covers the manufacture, importation and wholesale dealing in products.
- Requirement for authorisation (Part 4) – sets out that products must not be sold or supplied in the UK unless authorised by the UK licensing authority.
- Marketing authorisations (Part 5) – sets out the procedures for authorisation of medical products in various categories by the UK licensing authority.
- Certification of homoeopathic medicinal products (Part 6) – sets out the application process for obtaining a certificate of registration for homeopathic medicinal products.
- Traditional herbal registrations (Part 7) – set out the process for registration of herbal medicinal products.
- The concept of “force majeure” was frequently talked about during the Coronavirus pandemic and since authorisations (Part 8) – sets out the limited situations in which the UK licensing authority may grant an Article 126a authorisation for a medical product in Northern Ireland only where a medicinal product has been authorised in another EEA member state.
- Borderline products (Part 9) – sets out how to determine whether products supplied without authorisation are medical products and, therefore, subject to the regulations.
- Exceptions to requirement for marketing authorisations etc. (Part 10) – sets the conditions under which a person may sell or supply or offer to sell or supply a medical product without first obtaining a marketing authorisation, a certificate of registration, a traditional herbal registration or an Article 126a authorisation.
- Pharmacovigilance (Part 11) – consolidates previous legislation concerning the monitoring of the safety of medicines in clinical use.
- Dealings with medicinal products (Part 12) – sets out the circumstances in which products may be sold, supplied or administered, as well as provisions in relation to sale of medicines to the public at a distance.
- Packaging and leaflets (Part 13) – sets out the information that is to be supplied with products and consolidates provisions on child safety.
- Advertising (Part 14) - sets out the requirements and standards for the advertisement of medicines.
- British Pharmacopoeia (Part 15) – stipulates that the British Pharmacopoeia Commission must periodically prepare editions of British Pharmacopoeia and also a compendium containing relevant information relating to certain substances.
Gustaf Duhs
Elena Cafora