CRED 8 Presentations

08/07/2024

Differences MRP & DCP

MRP ● First submission to RMS only. RMS performs full assessment and issues a marketing authorisation. Subsequently start of the MRP in other Member States ● No clock stop/No withdrawal possible (in case of PSRPH) DCP ● Submission of dossier in RMS and (at least one) CMS at the same time. RMS takes the lead, but has not issued a marketing authorisation ● Clock stop/Partial withdrawal is possible (before day 120)

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

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Partial withdrawal

Since November 2005 : ● MRP: application can be withdrawn in MS which raised a PSRPH, but discussion between RMS and CMS will continue → if needed CMDh referral

● DCP: withdrawal in MS which raised a PSRPH before Day 120 will stop the discussion (no CMDh referral)

● DCP: application can be withdrawn in MS which raised a PSRPH after Day 120, but discussion between MSs will continue → if needed CMDh referral

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

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