This message was posted by a user wishing to remain anonymous
Dear RAPS Community,
I had a question relating to product lifecycle maintenance activities with EMA and the order in which variations should be submitted to EMA.
If an Applicant has an ongoing Type II variation procedure impacting the clinical overview (module 2.5), must the Applicant wait until a decision from CHMP is issued before they submit a separate variation for another change that also impacts module 2.5?
My feeling is they must wait until CHMP issues their decision on the ongoing procedure impacting module 2.5. After CHMP issued their decision the Applicant must then submit a closing sequence and then file the next variation which also impacts module 2.5.
Would welcome any feedback on this strategy from those experienced in product lifecycle maintenance activities with EMA.
Many thanks in advance!