CRED SMPC 2024

17/09/2024

Implications of Regional Differences for CCDS and Global Labelling Management

● For CCDS sections where labelling requirements differ, what should be included in CCDS? ● Company evaluates data and makes a decision – May include some optional sections or appendices ● CCDS reflects company position on safety & efficacy information ● Important to provide guidance on how to implement CCDS into regional/local labelling

The Organisation for Professionals in Regulatory Affairs

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Implications of when Country Labelling Deviates from CCDS

● Recommend there is a process to manage this ● Provide guidance on what is considered a ‘deviation’ ● Evaluate country-specific label statements – Rationale for statements e.g. health authority request ● Develop a company position on the country- specific label statements – Accept or not – Consider CCDS impact – If appropriate, based on company position, statements may be included in CCDS and implemented globally ● Document the deviation: important part of the labelling history

The Organisation for Professionals in Regulatory Affairs

18