CRED SMPC 2024

17/09/2024

Special considerations

Combining leaflets (CP only)

• Separate package leaflet should be provided per strength and per pharmaceutical form

• In order to request a combined PL, the applicant has to include a justification/rationale as part of the application for a Marketing Authorisation, a Line Extension, a Renewal, a Variation or an Article 61.3 Notification. The request will be discussed at one of the QRD Plenary meetings (or via written procedure in case of urgency) and a decision will be made on a case-by-case basis

•

Certain conditions need to be met:

– The posology in the SmPC/PL foresees at least two dosages (e.g., titration phase, dose adjustment based on clinical response or for special populations);

– The PLs are fully identical to the exclusion of minor strength-specific details, and

– The proposed combined PL does not cause any confusion or risk of misuse for the patient or user

The Organisation for Professionals in Regulatory Affairs

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Leaflet considerations

Literacy

•

Identify intended users

•

Use plain language – no Pharma jargon

•

Avoid complex language and sentences

- short sentences are best

•

Information provided in logical order

•

Active vs passive language

• Supplement text with graphics (without being promotional) • Engage end user in design • Check for understanding and usability

The Organisation for Professionals in Regulatory Affairs

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