CRED SMPC 2024

23/09/2024

Introduction

Crucial role in the regulatory framework for medicinal products:

• (SmPC) The Summary of medical Product Characteristics

• Intrinsic and integral part of the MA

• Describing the properties and officially approved conditions

• Summary – not all information; aims to provide important and relevant information clearly.

• Updated throughout the lifecycle of a medicine as new data emerge

The Organisation for Professionals in Regulatory Affairs

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The Role of the SmPC

• Legal mandatory document agreed and approved as part of the marketing authorisation of each medicinal product • The SmPC is based on facts and provides primary source information for healthcare professionals on how to use the medicinal product safely and effectively

• Essential tool in HCP clinical decision-making

• Basis for patient information leaflet and labels

• Sets the limits for MAH marketing and promotion

• SmPCs are dynamic and updated throughout the life-cycle of the product in line with current scientific knowledge via variations.

The Organisation for Professionals in Regulatory Affairs

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