CRED Managing Variations Effectively

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)