CRED SMPC 2024

17/09/2024

What is a draft label?

When

• A dynamic working draft of the SmPC

• Minimum acceptable wording in each section – Commercial (market access / reimbursement), Regulatory, Competitors, Clinical

Range of labelling options – Best case scenario – Realistic scenario from Clinical / Regulatory point of view

•

The Organisation for Professionals in Regulatory Affairs

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Labelling during development

When

• Starting a draft label early provides direction, focus and clear boundaries from early development onwards – Ensures optimal label is supported by coherent, robust data

• “Label drives development” is a key concept

The Organisation for Professionals in Regulatory Affairs

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