Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.
The European Medicines Agency (EMA) issued the warning earlier today, advising authorisation holders to submit any quality type-IA and type-IAin variations for 2012 by Friday 30 November and reminding them that its offices will be closed from December 24 to January 2.
Type-I variations are minor changes that have no impact on the quality, safety or efficacy of the medicine. Marketing-authorisation holders can implement changes of this type before validation by the Agency.
In contrast, type-IB variations can only be implemented once the EMA has accepted the variation or after 30 days following acknowledgment of receipt of a valid application.