CRED SMPC 2024

17/09/2024

Basic principle of a CCDS

CCDS contains critical information concerning the safe and effective use of the product. The CCSI portion of the CCDS must be included in the prescribing information in all countries where the drug is marketed except at the direct request of a local regulatory authority.

The Organisation for Professionals in Regulatory Affairs

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Structure and Format of CCDS

● One CCDS for each active ingredient – Consider >1 CCDS for different pharmaceutical forms if the labelling content is very different – Consider approaches for products with more than 1 active ingredient ● CIOMS recommends an SmPC type format using SmPC headings – But not mandated; other formats can be used – Write content with other label formats in mind ● Level of information depends on stage of development and lifecycle of product ● May also choose to have core patient information to complement the prescribing information

The Organisation for Professionals in Regulatory Affairs

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