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 https://health.ec.europa.eu/system/files/2023-06/2018_packaging_guidelines_en.pdf • Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf • CMDh Blue Box Requirements https://www.hma.eu/uploads/media/300115_CMDv_GUI-27_Blue-box_requirements.pdf • CMDh Position Paper on User Testing of Package Leaflet https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Consulation _PatientsGroups/CMDh_234_2011_Rev01_2016_12_clean.pdf • Guidance concerning the Braille requirements for Labelling and Package Leaflet for Human Use https://www.gmp-compliance.org/files/guidemgr/Braille_text20050411.pdf

The Organisation for Professionals in Regulatory Affairs

25

Relevant European Guidance

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

• Best Practice Guide on the Submission of High Quality National Translations https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General _Info/CMDh_255_2012_Rev1_2017_02_cleanx.pdf • Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/recommendations implementation-exemptions-labelling-package-leaflet-obligations-centralised_en.pdf • EMA Excipients in the label and Package Leaflet https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product information/reference-guidelines/excipients labelling#:~:text=While%20most%20excipients%20are%20considered,medicine%20for%20its%20s afe%20use. • Rapporteur Critical Assessment Report https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2 Fdocuments%2Ftemplate-form%2Fday-80-assessment-report-overview-and-d120-loq-template guidance-rev-1023_en.docx&wdOrigin=BROWSELINK

The Organisation for Professionals in Regulatory Affairs

26