Specific obligations
Article 5
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.