Spring Intro 2023

Jenny Lamport

Principal EU legislation

 Directive 2001/83/EC 6 November 2001 ● ……….. as amended by multiple Directives

– 2002/98/EC, 2003/63/EC – 2004/24/EC, 2004/27/EC – 2008/29/EC, 2009/53/EC, 2009/120/EC, – 2010/84/EU, 2011/62/EU, 2012/26/EU, 2019/1234………….

[Regulations ….. – eg 726/2004, 141/2000, 1901/2006, 1394/2007 as amended]

https://ec.europa.eu/health/documents/eudralex/vol-1_en

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e.g. SE: Medicinal Products Act (SFS 2015:315) Medicinal Products Ordinance (SFS 2015:458) IE: Medicines Board Act 1995 (as amended) [UK previously: Human Medicines Regulations SI 2012/1916 ] Member state legislation enacting the Directive

The Organisation for Professionals in Regulatory Affairs

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