Module 1 2021

30/06/2021

Eligibility

 Applications for MA in more than one member state  Open for all applications not falling under mandatory scope of the Centralised procedure ● New active substances; generic medicinal products; informed consent applications; bibliographic applications; known substances in new combinations; line extensions; herbal medicinal products; homeopathic products ;  Flexibility ● Choice of MSs ● Different trade names in different MSs ● Different MA Holders in different Member States;  Applicant to choose RMS  Possibility of Repeating Procedures

The Organisation for Professionals in Regulatory Affairs

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Overview of MRP and DCP DCP

MRP ● National registration in RMS ● (Updated) Assessment Report ● Dossier submission to CMS

● submission to RMS and CMS;

● Validation (14 days) ● Assessment I -120 days ● Assessment II – 90 days ● Discussion at CMDh (if necessary);

● Validation (14 days) ● 90 day assessment;

● Discussion at CMDh (if necessary) Total time 90 days (excluding clock stops)

Total time 210 days (excluding clock stops);

● National Phase;

● National Phase;

The Organisation for Professionals in Regulatory Affairs

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