Spring Intro 2023

EU MARKETING AUTHORISATION VARIATIONS

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Legal Basis of Variations - a brief history

•EU Variations Regulation (1234/2008) came into force on 01 January 2010 and replaced Regulations 1084/2003/EC and 1085/2003/EC •Regulation 1234/2008 only concerned variations handled via CP, MRP or DCP •Was amended by Regulation (712/2012) and includes national authorisations • Provide additional details on variation procedures and classifications outlined in Chapters II, IIa, III and IV of Regulation 1234/2008 •These guidelines are updated regularly to take into account scientific advances, industry trends, etc. •Current revision published in 2013

Variations Regulation (1234/2008) as

amended by (712/2012)

Variations Guidelines (2013/C 223/01)

European Commission announced an ambitious reform in the Pharmaceutical Strategy for Europe, adopted in November 2020. This will likely lead to changes to this coming soon – Watch this space!

The Organisation for Professionals in Regulatory Affairs

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