CRED SMPC 2024

23/09/2024

The Role of the SmPC

• Ensures Regulatory Compliance

• Standardised format

• Common basis for communication in EU

• Consistency - presentation of scientific data presented according to a predefined structure • The scientific assessment should evaluate how the SmPC will optimise the benefits and manage the risks • SmPCs can be found on competent authority websites and on the EMA website (centralised products)

The Organisation for Professionals in Regulatory Affairs

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SmPC – what information does it contain?

• Legal

• Pharmaceutical

• Clinical…. Efficacy

• Clinical…..Safety

The Organisation for Professionals in Regulatory Affairs

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