CRED Managing Variations Effectively

SmPC updates as following EU worksharing procedures e.g. Paed, PSUR/PhVig 

Extended release tablets: multiple separate variations, all impact on the PIL • Type II: s4.4 & s4.6 SmPC variations in line with CCDS • Type IB: Paed worksharing • Type IB: PSUR EU worksharing

Acceptable grouping ??? Possible answers: Yes No Not sure/grey area

• Change 1 (Type II): Update to s4.4 in line with a CCDS • Change 2 (Type IB or 1A): Implementation of decision following Article 31 Referral

138