Spring Intro 2023

03/03/2023

DCP

● Options at Day 210: (i) If consensus reached that product is approvable, RMS closes procedure and issues Final Assessment Report (FAR), go to National Step (ii) If RMS concludes that product is not approvable, RMS closes procedure and issues FAR; no CMDh referral (iii) If CMSs can’t approve a positive RMS AR on grounds of PSRPH, CMSs notify the RMS, CMSs, CMDh by 16:00 Central European Time, the RMS refers the matter to the CMDh ● By Day 270: Final position adopted by CMDh or CHMP arbitration

The Organisation for Professionals in Regulatory Affairs

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DCP

7 days after close of procedure ● Applicant sends high-quality national translations of SmPC, labelling and PIL to CMSs and RMS

● Artwork mockups also required 30 days after close of the procedure

● National marketing authorisation granted in Reference Member State and Concerned Member States if outcome is positive and there is no referral to CMDh 30 days after close of CMDh referral procedure ● National marketing authorisation granted in Reference Member State and Concerned Member States if positive conclusion by CMDh and no referral to the CHMP. ● National agencies will adopt the decision and will issue the marketing authorisation subject to submission of acceptable translations.

The Organisation for Professionals in Regulatory Affairs

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