Spring Intro 2023

03/03/2023

DCP - withdrawal

Applications may be withdrawn from a CMS at anytime

If serious public health concern is raised during Assessment Step II (after Day 120), the matter is referred to CMDh (unless all applications are withdrawn)

The Organisation for Professionals in Regulatory Affairs

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● Day -14: Applicant submits the dossier to Concerned Member States; ● Reference Member State circulates the assessment report, including SmPC, PIL and labelling to Concerned Member States. ● Application validation in the Concerned Member States. ● Day 0: Reference Member State starts the procedure. ● Day 30: Concerned Member States send their comments to the Reference Member State and applicant. ● Day 40: Applicant sends the response document to Concerned Member States and Reference Member State. ● Up to Day 48: Reference Member State circulates its assessment of the response document to the Concerned Member States. ● Day 55: Concerned Member States send their remaining comments to the Reference Member State and applicant. ● Day 55-59: RMS and applicant in contact to see if procedure can be closed ● Day 60: RMS closes procedure if no remaining CMS comments MRP

The Organisation for Professionals in Regulatory Affairs

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