Spring Intro 2023

03/03/2023

EU Current Legislation

• Current EU Legislation was published after a review in 2000/01 – implemented in 2005 ● Regulation EC no 726/2004 (New Centralised Procedure Regulation) ● Directive 2004/27 (amending Directive 2001/83/EC) • Covering multitude of areas e.g. ● Benefit-Risk, Marketing Authorisations, Generic Products, Mutual Recognition Procedure and new Decentralised Procedure, Referrals, GMP, Labelling, Leaflets ● The changes in legislation were as a result of scientific and technical progress and feedback from stakeholders

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Beyond Regulation 726/2004

• Orphan Drugs (Regulation (EC) 141/2000) • Advanced Therapy Medicinal Products (ATMP) (Regulation (EC) 1394/2007) • Paediatric (Regulation (EC) 1901/2006) • Variations (Regulation (EC) 1234/2008) • Pharmacovigilance (Regulation (EC) 1235/2010) • Clinical Trials (Regulation (EC) 536/2014) • Keep up-to-date…proposals to revise the legislation proposed in 2023 (if not adopted, next opportunity likely in 5 years). ● http://www.ema.europa.eu/ ● http://ec.europa.eu/health/human-use ● http://www.hma.eu

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