CRED SMPC 2024

17/09/2024

Classification of CCDS Information

● In some companies all information in CCDS is considered mandatory – Text: Incorporation verbatim – Concepts: Text should be consistent with CCDS ● Other companies have different classification levels of information in CCDS

– Mandatory: Text/Concepts – Optional: Text/Concepts

The Organisation for Professionals in Regulatory Affairs

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● Historically a reactive, retrospective region-specific process ● Generally now a more proactive, prospective, global process – Focus on target label throughout development – Design the development programme to support desired labelling claims and the optimum product labelling – Developed with multiple countries in mind – CCDS developed ahead of or in parallel with major markets – CCDS should be agreed before first country submission - establishes the company position – CCDS evolves as new data become available – continues to be the reference for all labels globally Company Preparation of Labelling

The Organisation for Professionals in Regulatory Affairs

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