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Protein Assay

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Protein Assay
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

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