CRED SMPC 2024

18/09/2024

Your Scenario

Your company has an existing national marketing authorisation in country Watopia for an oral tablet presentation. The product strategy is to register the same product using the EU centralised procedure. The product team needs you to review and revise the SmPC . Check for correctness, completeness and consistency with EU regulatory requirements (EU centralised procedure). The draft SmPC here is presented in the EU combined product information format.

The Organisation for Professionals in Regulatory Affairs

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Example – Section 1

1. NAME OF THE MEDICINAL PRODUCT https://www.ema.europa.eu/en/documents/template-form/qrd-product-information-annotated template-english-version-104_en.pdf

10mg film-coated tablets TOPRAMAAX 50mg film-coated TOPRAMAAX tablets TOPRAMAAX 100mg tablets

The Organisation for Professionals in Regulatory Affairs

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