reference safety information
- Guideline or reference source
- ICHE2C(R2) Guideline
- Definition
- All relevant safety information contained in the reference product information (e.g., CCDS) prepared by the MAH and which the MAH requires to be listed in all countries where the company markets the drug, except when the local regulatory authority specifically requires a modification. It is a subset of information contained within the MAH’s reference product information for the PBRER. Where the reference product information is the Company Core Data Sheet (CCDS), the reference safety information is the Company Core Safety Information (CCSI).
- Abbreviation for
- RSI
- Related Term
- company core data sheet
- company core safety information
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