The Italian Medicines Agency AIFA provides some clarifications to all pharmaceutical companies regarding the submission of changes to the AIC. These clarifications concern the changes presented according to the national, mutual recognition/decentralized (MR/DC) procedure pursuant to EC Regulation No. 712/2012 and in line with the new “classification guidelines” of the European Commission dated 16/05/2013. The objective is to favor the correct presentation by companies of applications concerning changes to the AIC. You can find enclosed the update of the Explanatory Note of the AIFA Resolution of 25 August 2011.
August 4, 2021