CRED SMPC 2024

23/09/2024

Useful links – European Commission

European Commission “A Guideline on Summary of Product Characteristics. Ref: https://ec.europa.eu/health/sites/health/files/files/eudral ex/vol-2/c/smpc_guideline_rev2_en.pdf

The Organisation for Professionals in Regulatory Affairs

45

Useful links - CMDh

The Co-ordination group for Mutual Recognition and Decentralised Procedures – Human (CMDh) website https://www.hma.eu/cmdh.html for:

• Any previously recommended Pharmacovigilance working party recommendations and sometimes class effects wording*

• Any CMDh recommendations or advice from CMDh for SmPC wording for a particular active substance

• Some agreed core SmPCs

• The MRI Product index which often gives agreed product information from MR/DCP procedures • Paediatric Regulation: Any published Article 45 or Article 46 which may have recommendation for SmPCs with regard to use in the paediatric population

The Organisation for Professionals in Regulatory Affairs

46

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