S.L. 458.35 ст. 8The Authority may impose obligation.

The Authority may impose an obligation on a marketing authorisation holder to operate a risk management system, as referred to in regulation 6(4)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product. In that context, the Authority shall also oblige the marketing authorisation holder to submit a detailed description of the risk-management system which he intends to introduce for the medicinal product concerned. The imposition of such obligations shall be duly justified, notified in writing and shall include the timeframe for submission of the detailed description of the risk-management system.