CRED SMPC 2024

23/09/2024

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SmPC

e Prescribing

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Package Leaflet

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The Organisation for Professionals in Regulatory Affairs

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The Role of the SmPC

• Regulatory Authority MA and LCM assessment • Communication tool for appropriate delivery of concise relevant information to HCPs • Source document to facilitate clinical decision-making

• Adaptable to legal and scientific changes • A “living” constantly changing document

The Organisation for Professionals in Regulatory Affairs

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