CRED SMPC 2024

17/09/2024

Relevant European Guidance

For Reference (Links also listed at end of slides):

• Guideline on the Packaging Information of Medicinal Products for Human Use Authorized by the Union • Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use • CMDh Blue Box Requirements • CMDh Position Paper on User Testing of Package Leaflet • Guidance concerning the Braille requirements for Labelling and Package Leaflet for Human Use • Best Practice Guide on the Submission of High Quality National Translations • Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure • EMA Excipients in the label and Package Leaflet • Rapporteur Critical Assessment Report

The Organisation for Professionals in Regulatory Affairs

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EU CP vs. MRP/DCP - Similarities

Directive 2001/83/EC

Article 54 outlines requirements for outer packaging (Or immediate when there is no outer packaging) Article 55 states particulars listed in Article 54 must appear on immediate packaging except for

QRD template (SmPC/Label/Leaflet)

• Issued for MRP/DCP (already in place for CP)

– Blister packs – Small immediate packaging units

• Annotated version has guidance notes to follow and reference to relevant appendices and guidance

Directive 2004/27/EC (effective Oct 2005)

• Standard terms and statements

Brought alignment in process for CP/MRP/DCP

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• Introducing ADR reporting statement and products subject to additional monitoring

Harmonisation of labels and leaflets for MRP/DCP Introduced ‘blue - box’ on packaging for national labels (MRP/DCP)

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The Organisation for Professionals in Regulatory Affairs

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