CRED SMPC 2024

17/09/2024

Practical Issues Preparing Labels and Leaflets

• Familiarity with relevant EU directives, guidelines and QRD templates etc • Understanding submission and Agency review process to ensure all steps/scenarios to approval are planned

• What related documents are required for submission?

• Internal process for artwork/pack development and who is involved

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Device IFUs/additional HCP information

The Organisation for Professionals in Regulatory Affairs

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Special Considerations

Drafting labels and leaflets

• Product information written and submitted in English only

• Separate leaflets required for each strength and pharmaceutical form (unless allowed to combine)

• Label and leaflet must be consistent with SmPC (Article 61(3) of EU directive)

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QRD template can be used as starting point

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Use statements and standard term as applicable

The Organisation for Professionals in Regulatory Affairs

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