The Human Medicines Regulations 2012
PART 1- Contains provisions and an explanation of the role of ministers and licensing authorities PART 2- How different advisory bodies operate (including the commission on Human Medicines and the British Pharmacopoeia Commission PART 3- Rules for manufacturing, importing and wholesale dealing (requiring a legally obtained license) PART 4- Requirement for authorisation to sell/supply medicinal products, i.e. they must be from an appropriate marketing authorisation PART 5- Requirements regarding the UK marketing authorisations (in determining whether a product is subject to prescription requirements) PART 6- Certification of medicinal products. Rules about revocations, variation, withdrawals, suspensions etc PART 7- Traditional herbal registrations for traditional herbal medicinal products. Rules about revocations, variation, withdrawals, suspensions etc PART 8- Permits member states to authorise the placing on the market of medicinal products without authorisation from a UK marketing authorisation PART 9- Borderline products (unlicensed product that is determined as a medicinal product) PART 10- Exception to requirement for a marketing authorisation. Unlicensed medicinal products can be supplied under certain conditions PART 11- Pharmacovigilance, the monitoring of the safety of medicines in clinical use to minimise risk PART 12- Bringing together many provisions to set rules for the sale, supply and administration of medicinal products related to their classification (e.g. prescription only). Exemptions are also created. PART 13- Packaging and leaflets. Sets out information that must appear on packaging and in leaflets PART 14- Contains prohibitions on advertising, and information that must be included in them. Also requires ministers to consider complaints about unsuitable adverts. PART 15- Provides for the publication of the British Pharmacopoeia and other documents...
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