CRED SMPC 2024

17/09/2024

Post-approval

• Development of the optimum label continues for the lifetime of the compound • Voluntary changes - Variations for new indications, extensions of existing indications, new clinical trial data …etc • Mandatory changes (e.g. referrals, harmonisation, outcomes of post-marketing safety surveillance) • Same general principles apply as for the NCE application • Ensure supporting documents created in good time and justify/consistent with proposed changes

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Conclusion

Wording based on several factors ● CCDS

● Data – existing or expected ● Interpretation of the data ● Regulatory precedent ● Class labelling ● Template options & standard terms ● Guideline wording

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