CRED SMPC 2024

17/09/2024

Implementation Monitoring

● Company approaches will differ ● May be a central/HQ review of affiliate labels before submission

● Provide guidance on submission timing, taking into consideration labelling dependencies/other local regulatory considerations. Particularly key for safety-related changes ● Responses to regulatory authority labelling issues; management of deviations from the CCDS ● Track implementation – Formal tracking systems/spreadsheets – increasing trend for end-to-end ● Audits: product or process/system – may also include partner companies (if relevant).

The Organisation for Professionals in Regulatory Affairs

15

Differences in Regional Labelling Requirements

● Common themes, but structure/format and level of detail may differ ● Some country/region-specific requirements - consider whether/how these will be addressed in the CCDS – e.g. Region-specific population data

The Organisation for Professionals in Regulatory Affairs

16