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July 2024
The UK government has made several changes to the Human Medicines Regulations 2012, including the omission of Regulation 43A, amendments to Regulation 44, and the introduction of new categories of UK marketing authorizations. These changes mark a regulatory shift post-Brexit, defining “UK marketing authorization” to encompass categories such as UKMA(UK), UKMA(UK), UKMA(GB), and UKMA(NI), each with specific territorial permissions for marketing medicinal products.
Regulation 257AA addresses variations in packaging requirements, including a new “UK only” labeling mandate for products marketed in Northern Ireland. Specific provisions also outline data and marketing exclusivity periods for medicinal products across different UK territories.
The document provides detailed requirements for reporting individual case safety reports and study protocols. It also defines the licensing authority’s power to request information from license applicants or current license holders. Inspectors are authorized to collect samples, request information, and seize products if they suspect an offense. The structure and content of study protocols are highlighted, stressing the significance of amendments and updates.
Holders of UK marketing authorizations or parallel import licenses must provide information that could influence the assessment of their products’ benefits and risks, demonstrating that the positive therapeutic effects continue to outweigh any potential risks.
Region: United Kingdom
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