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Guzzi62

10/18/25 6:14 AM

#503529 RE: Investor2014 #503528

Hmm, maybe you should check your facts before you speak with great gusto, that turns up to be false, huh!!!!


From your link:

Conditional marketing authorisations are valid for one year and can be renewed annually.

Once a conditional marketing authorisation has been granted, the marketing authorisation holder must fulfil specific obligations within defined timelines.

These obligations could include completing ongoing or new studies or collecting additional data to confirm the medicine's benefit-risk balance remains positive.

EMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report.

The marketing authorisation can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the marketing authorisation holder fulfils the obligations imposed and the complete data confirm that the medicine's benefits continue to outweigh its risks. Initially, this is valid for 5 years. It can then be renewed for unlimited validity.