1.The tasks of the Paediatric Committee shall include the following:
(a)to assess the content of any paediatric investigation plan for a medicinal product submitted to it in accordance with this Regulation and formulate an opinion thereon;
(b)to assess waivers and deferrals and formulate an opinion thereon;
(c)at the request of the Committee for Medicinal Products for Human Use, a competent authority or the applicant, to assess compliance of the application for a Marketing Authorisation with the agreed paediatric investigation plan concerned and formulate an opinion thereon;
(d)at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;
(e)to advise on the content and format of data to be collected for the survey referred to in Article 42;
(f)to support and advise the Agency on establishing the European network referred to in Article 44;
(g)to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
(h)to provide advice on any question related to medicinal products for use in the paediatric population, at the request of the Executive Director of the Agency or the Commission;
(i)to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43;
(j)to advise the Agency and the Commission regarding the communication of arrangements available for conducting research into medicinal products for use in the paediatric population;
(k)to make a recommendation to the Commission on the symbol referred to in Article 32(2).
2.When carrying out its tasks, the Paediatric Committee shall consider whether or not any proposed studies can be expected to be of significant therapeutic benefit to and/or fulfil a therapeutic need of the paediatric population. The Paediatric Committee shall take into account any information available to it, including any opinions, decisions or advice given by the competent authorities of third countries.