CRED 8 Presentations

08/07/2024

RMS/CMS comments

CMS must differentiate between  Potential Serious Risks to Public Health (PSRPH) (= major objections)  Points for Clarification (= other concerns) Standard comment templates!

CMS only allowed not to recognise the RMS assessment if there is a PSRPH

NB: New data submitted with responses during the procedure may lead to new PSRPH

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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MRP/DCP - Practical Tips National Phase

In Theory: • Translation of EU PI

In Practice • Translation of EU PI

submitted within 5 Days after close of procedure;

submitted within 5 Days after close of procedure;

• Member State grant

• Member State grant

national licences within 30 days

national licences within 30 days up to 1 year (resources, patent situation, pricing and reimbursement

Collect Company’s experience on approval timelines

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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