CRED SMPC 2024

17/09/2024

How do you fill the boxes?

How

Company Core Data Sheet

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➢ If a CCDS has been developed, this will drive much of the content; text should be adapted to meet local regulatory requirements • Data from clinical studies, non-clinical studies ➢ Text based on actual data and its interpretation or realistic potential data (if data not yet available) • Regulatory Precedent

➢ What labelling exists for comparable compounds ?

➢ EMA website, eMC, HMA MRI product index etc What did other compounds need to do to get labelling approved?

➢ European Public Assessment Reports (EPARS)

• Link to eMC: https://www.medicines.org.uk/emc • https://www.emcmedicines.com/en-GB/northernireland/ • https://www.hma.eu/human-medicines/mri-product-index.html

The Organisation for Professionals in Regulatory Affairs

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Key Guideline

How

https://health.ec.europa.eu/system/files/2016-11/smpc_guideline_rev2_en_0.pdf

The Organisation for Professionals in Regulatory Affairs

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