Medicines Act 1968: Primary UK legislation governing the manufacture, distribution, and sale of medicines, establishing the licensing system for medicinal products
Human Medicines Regulations 2012: Modern regulatory framework for medicines in the UK, including requirements for marketing authorizations, manufacturing, wholesale dealing, and pharmacovigilance
Patents Act 1977: Key legislation governing patent rights and protection in the UK, crucial for pharmaceutical intellectual property
Trade Marks Act 1994: Legislation protecting branding and trademark rights, relevant for pharmaceutical product names and branding
Competition Act 1998: Regulates anti-competitive behavior and agreements, particularly relevant for pharmaceutical licensing and market access
Intellectual Property Act 2014: Modernized IP protection framework, including provisions affecting pharmaceutical patents and designs
EU Regulation 726/2004: Retained EU law establishing procedures for authorization and supervision of medicinal products
EU Directive 2001/83/EC: Retained EU law providing community code relating to medicinal products for human use
UK GDPR: Data protection regulation governing the processing of personal data, including patient and clinical trial information
Data Protection Act 2018: UK's implementation of data protection requirements, complementing UK GDPR
Technology Transfer Block Exemption Regulation: Competition law exemptions for technology transfer agreements, including pharmaceutical licensing
Enterprise Act 2002: Framework for merger control and market investigations in the pharmaceutical sector
MHRA Guidelines: Regulatory guidelines from the Medicines and Healthcare products Regulatory Agency for pharmaceutical products
GMP Requirements: Good Manufacturing Practice standards ensuring pharmaceutical product quality and safety
Pharmacovigilance Requirements: Regulations for monitoring and reporting adverse effects of pharmaceutical products
International Patent Conventions: International agreements governing patent protection across jurisdictions
WHO Guidelines: World Health Organization standards and guidelines for pharmaceutical products
ICH Guidelines: International Council for Harmonisation technical requirements for pharmaceuticals
Unfair Contract Terms Act 1977: Legislation controlling unfair terms in contracts, applicable to licensing agreements
Environmental Protection Act 1990: Environmental regulations affecting pharmaceutical manufacturing and waste disposal
