In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of determining the situations in which post-authorisation efficacy studies may be required, specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal, specifying the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations, establishing procedures for the examination of applications for the transfer of marketing authorisations, laying down the procedure and rules for the imposition of fines or periodic penalty payments for a failure to comply with the obligations under Regulation (EC) No 726/2004 as well as the conditions and methods for their collection.
Chun eilimintí neamh-riachtanacha áirithe de Rialachán (CE) Uimh. 726/2004 a fhorlíonadh nó a leasú, ba cheart an chumhacht chun gníomhartha a ghlacadh i gcomhréir le hAirteagal 290 CFAE a tharmligean chuig an gCoimisiún i ndáil leis na cásanna a chinneadh ina bhféadfadh gá a bheith le staidéir éifeachtúlachta iar-údarúcháin, nósanna imeachta a bhunú maidir le hiarratais ar aistriú údaruithe margaíochta a scrúdú, lena sonrófar na catagóirí táirgí íocshláinte a bhféadfaí údarú margaíochta a dheonú faoi réir oibleagáidí sonracha agus lena sonrófar na nósanna imeachta agus na ceanglais maidir leis an údarú margaíochta sin a dheonú agus lena athnuachan, lena sonrófar na catagóirí inar cheart athruithe a aicmiú agus lena mbunaítear nósanna imeachta chun scrúdú a dhéanamh ar iarratais ar athruithe ar údaruithe margaíochta, lena mbunaítear nósanna imeachta maidir le hiarratais ar aistriú údaruithe margaíochta a scrúdú, agus lena leagtar síos an nós imeachta agus na rialacha maidir le fíneálacha nó íocaíochtaí pionósacha tréimhsiúla a fhorchur maidir le mainneachtain na hoibleagáidí a chomhlíonadh faoi Rialachán (CE) Uimh. 726/2004 a fhorchur, chomh maith le coinníollacha agus modhanna a mbailithe.