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Posted On: 09/15/2024 2:18:37 AM
Post# of 148870
Someday for LL
EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
the benefit-risk balance of the medicine is positive;
it is likely that the applicant will be able to provide comprehensive data post-authorisation;
the medicine fulfils an unmet medical need;
the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
https://www.ema.europa.eu/en/human-regulatory...horisation
EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
the benefit-risk balance of the medicine is positive;
it is likely that the applicant will be able to provide comprehensive data post-authorisation;
the medicine fulfils an unmet medical need;
the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
https://www.ema.europa.eu/en/human-regulatory...horisation
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