Spring Intro 2023

03/03/2023

DCP

Four Steps: ● Pre-procedural Step (Validation)

● Assessment Step I ● Assessment Step II ● National Step - National Marketing Authorisations issued

Or • Referral to CMD(h) (if needed)

The Organisation for Professionals in Regulatory Affairs

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DCP

● Applicant must inform the RMS that application will be made ● Advised to discuss application with RMS ● RMS will allocate a procedure number for the application ● For generic MA - provide RMS with an overview of the indications, posology, contraindications and special warnings, PIL and label for innovator products. RMS will discuss extent to which harmonisation can be achieved ● Prepare country specific requirements – translations, fees etc

The Organisation for Professionals in Regulatory Affairs

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