CRED Managing Variations Effectively

Composite Coordinated Collection (CCC)

What about variations that can’t be grouped?

V1 New product name (own label supplier )

V3 Updated label/PIL artwork redesign (P2/3)

V2 CCDS updates: s4.4, 4.5, 4.6, 4.7, 4.8 and QRD changes

– Coordinated submission and assessment – Normal rules for bulking/grouping

– One label / PIL mockup – One consolidated SPC – ‘one stop shop’

MHRA guidance:- https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your- marketing-authorisation

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