the obligation to operate a risk management system as provided for in Article 14a and Article 21(2) of this Regulation in conjunction with Article 104(3) of Directive 2001/83/EC and Article 34(2) of Regulation (EC) No 1901/2006;
an oibleagáid córas bainistithe riosca a oibriú, amhail dá bhforáiltear in Airteagal 14a agus in Airteagal 21(2) den Rialachán seo i gcomhar le hAirteagal 104(3) de Threoir 2001/83/CE agus Airteagal 34(2) de Rialachán (CE) Uimh. 1901/2006;