Spring Intro 2023

03/03/2023

● Day 60-90: Only if CMSs remaining comments ● Day 60: Applicant submits responses to RMS and CMS ● By Day 68: Reference Member State circulates its assessment of the response document to the Concerned Member States. ● Day 75: Concerned Member States send their remaining comments to the Reference Member State and applicant. ● A break-out session can be organised between Days 75 - 80. ● Day 85 : Concerned Member States send any remaining comments to the Reference Member State and applicant. ● Day 90: End of procedure (mutual recognition/referral to CMDh) MRP

The Organisation for Professionals in Regulatory Affairs

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MRP

● Day 90 CMS notify the RMS and applicant of their final positions (in case of negative positions, also EMA’s CMD secretariat) ● If consensus is reached, the RMS closes the procedure. ● If consensus is not reached, points of disagreement submitted by CMS are referred to CMDh by the RMS within seven days after Day 90. ● 5 Days After Procedure Closes: Applicant sends high-quality national translations of SmPC, PIL and labelling to CMS and the RMS. ● 30 Days After Procedure Closes: National MAs are granted in the CMS, subject to submission of acceptable translations. For procedures referred to CMDh: ● Day 150: if consensus is reached at the CMDh level, the RMS closes the procedure. If consensus is not reached at the CMDh level, the RMS refers the matter to CHMP for arbitration.

The Organisation for Professionals in Regulatory Affairs

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