European Medicines Agency encourages submission of quality type-I variations by end of November
The European Medicines Agency is advising marketing-authorisation holders to submit any quality type-IA and type-IAIN variations for 2012 by Friday 30 November, wherever possible.
This will enable the Agency to acknowledge the validity of the applications before the Agency's closure between 24 December 2012 and 2 January 2013 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
Marketing-authorisation holders intending to apply for quality type-IB variations in December 2012 should liaise with the Agency prior to their submission.
Type-I variations are minor changes to a marketing authorisation. Type-IA and IAIN variations have no impact on the quality, safety or efficacy of the medicine and can be implemented by the marketing-authorisation holder before validation by the Agency. Type-IB variations can only be implemented once the Agency has accepted the variation or after 30 days following acknowledgment of receipt of a valid application.