EMA calls for submission of Type-1 MA variations before end of November
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.
