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 system has now been in operation for six months (as at August 2010) and is still relatively new for some companies. Depending upon how many Type IA variations a company may have had to manage during this period, experience is still being gained. To help ensure that companies are submitting the new Type IA notifications correctly MHRA has published details of its experience to date and an audit of submissions made in June 2010.