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The Regulations amended, consolidated and repealed a significant number of prior laws in this area, and underpin much of the regulation of medicines in the UK.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 or by the European Medicines Agency.
- 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.
- Article 126a authorisations (Part 8) – sets out situations in which the UK licensing authority may grant an Article 126a authorisation for a medical product, this applies where a medicinal product has been authorised in another EEA member state and is to be imported to the UK.
- 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.
- 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.
There are likely to be a large number of changes to these Regulations as a result of the UK’s withdrawal from the EU, currently covered in draft regulations.
Gustaf Duhs
Elena Cafora