CRED SMPC 2024

17/09/2024

EMA training slides

https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/product-information/how-prepare-review summary-product-characteristics

The Organisation for Professionals in Regulatory Affairs

47

EMA training slides

• Covers all sections of the SmPC, with additional topics such as generic/hybrid/biosimilar products • Summarises guidance from the SmPC Guideline

• Shows some practical examples

Provides FAQs, e.g.

•

The Organisation for Professionals in Regulatory Affairs

48