CRED 8 Presentations

08/07/2024

General principle DCP

● Applicant submits a dossier simultaneously to the RMS and at least one CMS (day -14)

● RMS assessment (day 70) is supplemented with CMS comments (day 100)

● Clock stop (day 105)

● Following the applicant’s response, there is an option for (>)2nd round of assessment

● RMS/CMS grant national marketing authorisation

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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Similarities MRP & DCP

● Reference Member State (RMS) takes the lead in the assessment

● Distribution of Assessment Report by RMS, followed by a 90 days period during which Concerned Member States (CMS) can indicate whether they recognise the RMS assessment

● If consensus can not be reached: CMDh referral and if necessary CHMP referral

● Harmonised assessment and outcome, but national marketing authorisations

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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