Module 6

04/10/2024

Questions?

Contact information:

Michelle Gleed

Email -michellegleed@camdialimited.com

The Organisation for Professionals in Regulatory Affairs

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References and useful links

Product Information • https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information reference-documents-guidelines • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information templates-human • https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information requirements/electronic-product-information-epi SmPC EC Guideline on Summary of Product Characteristics • https://health.ec.europa.eu/system/files/2016-11/smpc_guideline_rev2_en_0.pdf How to prepare and review a SmPC (EMA training materials) • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/how-prepare-review summary-product-characteristics Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications - Scientific guideline • https://www.ema.europa.eu/en/assessment-smpc-section-51-guide-assessors-centralised-applications-scientific-guideline Enhancing consistency in wording of therapeutic indications to support healthcare decision-making • https://www.ema.europa.eu/en/news/enhancing-consistency-wording-therapeutic-indications-support-healthcare decision-making

The Organisation for Professionals in Regulatory Affairs

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