Article 5 Specific obligations
1 By way of specific obligations, the holder of a conditional marketing authorisation shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data referred to in Article 4(1).
In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
2 The specific obligations referred to in paragraph 1 and the timeframe for their completion shall be clearly specified in the conditional marketing authorisation.
3 The Agency shall make the specific obligations and the timeframe for their completion publicly available.