Spring Intro 2023

03/03/2023

Warnings and pharmacological information

Warnings Some of the risks observed in the studies

Pharmacological properties Study results

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How to mitigate the risks

Centralised procedure Scientific advice, pre-submission meeting, clarification TC after every LoQ, oral hearing – before opinion, if there are queries Decentralised Scientific Advice, Regulatory advice, Clarification TC if required, Unanimous decision – no meetings;

MRP Different views - RMS – CMS – referral – CMDh – oral hearing; if negative – CHMP referral – oral hearing

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