Spring Intro 2023

03/03/2023

● Pre-procedural (Validation) Phase ● Day-14: Submission to all MS (RMS & CMS) where MA is sought ● Applicant must confirm that the dossier, SmPC, PIL and label are submitted to all MS are identical ● In theory, automatic validation after 14 days unless MS invalidate - Always check with RMS... DCP

The Organisation for Professionals in Regulatory Affairs

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DCP

● Day 0: Reference Member State starts the procedure ● Day 70: Reference Member State forwards the Preliminary Assessment Report (PrAR), SmPC, PIL and labelling to Concerned Member States and the applicant ● Up to Day 100: CMS send their comments to RMS and applicant ● Up to Day 105: Consultation between the Reference Member State, Concerned Member States and applicant ● If consensus is not reached, the Reference Member State stops the clock to allow the applicant to supplement the dossier and respond to questions

The Organisation for Professionals in Regulatory Affairs

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