MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs
The new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has also applied it to purely national variation applications since then.
The source of the news: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON091068