CRED SMPC 2024

17/09/2024

Further Resources

The Organisation for Professionals in Regulatory Affairs

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Scientific guidelines with SmPC recommendations

Just some examples – full list at the link below. Latest version; 09 January 2024 EMA/813125/2012 rev. 7

• https://www.ema.europa.eu/en/documents/other/scientific-guidelines-summary product-characteristics-recommendations_en.pdf • https://www.ema.europa.eu/en/human-regulatory-overview/research development/scientific-guidelines

The Organisation for Professionals in Regulatory Affairs

46