Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
The new Variations Regulation (EC/1234/2008) (external link) 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 we have published details of our experience to date and an audit of submissions made in June 2010. We have also updated the FAQs.
Variations to licences: Experience to date
