IMPORTANT NOTE: When completing this form please keep in mind that the primary purpose of requesting this information is that the assessment report will authority mention APIMF details that are no longer stated in the current APIMF. This form should allow the assessor to quickly determine what has changed, when this change occurred, for what reason and by what mechanism. The assessor must reconcile those details assessed originally by the and those details currently proposed. It is important therefore to: authority identify the differences between the details mentioned in the assessment report and those stated in the APIMF submitted to WHO explain why these details are different, i.e. were they changed at the request of the during assessment, changed by post-approval authority variation, or changed for the purposes of submission to the WHO. History of Changes table APIMF details currently accepted by the authority for this APIMF Common APIMF details APIMF APIMF Details Technical accepted by details originally Current Document the authority at being submitted to details Date of (CTD) time of initial proposed to Reason for Notification the authority accepted notification section approval WHO change type by to authority authority For example Updated specifications Original API to include a Tightening V004 24th January V004 – – 3.2.S.4.1 specifications test for of solvent Type IA 2012 Feb-12 V001 Aug-11 residual limit – solvents V003 Nov-11 –
IMPORTANT NOTE: When completing this form please keep in mind that the primary purpose of requesting this information is that the authority assessment report will mention APIMF details that are no longer stated in the current APIMF. This form should allow the assessor to quickly determine what has changed, when this change occurred, for what reason and by what mechanism. The assessor must reconcile those details assessed originally by the authority and those details currently proposed. It is important therefore to: identify the differences between the details mentioned in the assessment report and those stated in the APIMF submitted to WHO explain why these details are different, i.e. were they changed at the request of the authority during assessment, changed by post-approval variation, or changed for the purposes of submission to the WHO. History of Changes table Common Technical Document (CTD) section APIMF Details originally submitted to the authority APIMF details accepted by the authority at time of initial approval APIMF details currently accepted by the authority for this APIMF APIMF details being proposed to WHO Current details accepted by authority Reason for change Notification type Date of notification to authority For example 3.2.S.4.1 Original API specifications V001 – Aug-11 Updated specifications to include a test for residual solvents V003 – Nov-11 V004 – Tightening of solvent limit Type IA 24th January 2012 V004 – Feb-12