Criteria and conditions
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.
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.
As for any medicine, if new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation.
EMA can also take regulatory action if the company does not comply with the imposed obligations.