CRED SMPC 2024

17/09/2024

The SmPC is an integral part of the marketing authorisation

What

m1-3-1-spc-label-pl SmPC is the ultimate summary of the Common Technical Document (CTD)

Module 1 Regional Administrative Information

2.1 CTD table of contents 2.2 CTD Introduction

2.5 Clinical overview

2.4 Non-clinical overview

2.3 Quality overall summary

2.6 Non-clinical written & tabulated summaries

2.7 Clinical summary

Module 3 Quality

Module 4 Non-clinical study reports

Module 5 Clinical study reports

A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) September 2009 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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What

The SmPC sets out the agreed position of the medicinal product as distilled during the course of the assessment process between the Company and the Health Authority

A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) September 2009 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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