Spring Intro 2023

Current legislation – label and leaflet requirements

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Implementation of requirements in the UK

National legislation: The Human Medicines Regulations 2012 number 1916 [SI 2012/1916]. Set out in chapter 13 and schedules 24, 25, 26 and 27

EU legislation (with respect to Northern Ireland): Directive 2001/83/EC (amended by 2004/27/EC)

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