CRED SMPC 2024

23/09/2024

EU SmPC legislation - history

Directive 83/570/EEC…

It is necessary from the point of view of public health and free movement of medicinal products for the competent authorities to have at their disposal all useful information on authorised medicinal products based in particular on summaries, adopted in other member states, of the characteristics of products.

The Organisation for Professionals in Regulatory Affairs

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EU SmPC legislation

Directive 2001/83/EC as amended

This directive lays down the community code relating to medicinal products for human use. It specifies the requirements for the SMPC including its structure and content and

TITLE III: PLACING ON THE MARKET

CHAPTER 1: Marketing authorisation

Article 11 states: The summary of the product characteristics shall contain, in the order indicated below, the following information: Sections 1-12 are outlined

The Organisation for Professionals in Regulatory Affairs

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