CRED Managing Variations Effectively

Chapter B – example

Proposal: WonderPil strength 200mg has currently authorised the following pack sizes:  7 tablets and 28 tablets. The MAH wants to introduce two additional pack sizes of 14 and 84 tablets, to be

consistent with the recently approved posologies: “one tablet to be taken once daily for 14 days.” “one tablet to be taken once daily for up to 3 months.”

54 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations