Specific obligations refer to the requirements that are imposed on holders of conditional marketing authorizations or marketing authorizations granted under exceptional circumstances. These obligations are put in place to ensure that the authorized medicine is used safely, effectively, and in accordance with the specific conditions or circumstances under which the authorization was granted.
Conditional marketing authorization and marketing authorization under exceptional circumstances are regulatory mechanisms that allow the marketing and use of medicines in situations where comprehensive data on the medicine’s efficacy and safety are not yet available or where the benefit-risk balance is considered positive despite certain uncertainties. These authorizations are typically granted in cases of urgent medical need, rare diseases, or when the benefits of the medicine outweigh the risks and additional data collection is required.
When a medicine is granted a conditional marketing authorization or authorization under exceptional circumstances, specific obligations are imposed on the holder of the authorization.
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