1/ CMDh/EMA Working Party on Pediatric Regulation
Rapporteurs were appointed for the Art. 46 submissions. Member States (MSs) were reminded that the new process agreed in the July meeting entered into force (see our News of 30/09/2022), and the appointed Art. 46 rapporteur has to send the letters to the MAH to request the submission of the relevant data for a worksharing procedure or to inform the MAH if another procedure will apply (the letters were sent previously by the EMA).
2/ Working Party on Variation Regulation
The WP discussed which classification(s) is/are appropriate in case of significant changes to the ASMF/active substance part of the dossier. The WP agreed that changes in the ASMF that are introduced in the same way and without any additional information or need for individual assessment also in the manufacturers’ part of Module 3 can be regarded as consequential changes.
The WP discussed the validation phase of WS procedures for quality type IB variations and the …