Traduction de «Jour reservé à l'étude d'une question » (Français → Anglais) :

1. Following receipt of a proposed paediatric investigation plan which is valid in accordance with the provisions of Article 15(2), the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.

40. Notes that a number of essential issues relating to the purchase of the WIC and SDM buildings in Strasbourg have not as yet been adequately clarified or justified; expects that, should negotiations be resumed, the final package agreed upon should give value for money to the Institution; decides, pending the outcome of these negotiations, not to enter EUR 50 000 000 under Item 2003, and to transfer this amount to a building reserve to be created under Title 10 (Chapter 10 5 -"Provisional appropriation for buildings" ); decides, ...[+++]consequently, to delete Item 2009 ("Provisional appropriation to cover the institution's property investments" ); the funds put in reserve will be released once a set of conditions to be formulated has been satisfied; requests that the criteria for the release of the reserve be agreed with the relevant committee; expects that by 1 September 2006 the Bureau will come back with concrete proposals on this matter;

1. Following receipt of a proposed paediatric investigation plan which is valid, the Paediatric Committee shall appoint a rapporteur and shall within a maximum period of 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.

1. Following receipt of a proposed paediatric investigation plan which is valid, the Paediatric Committee shall appoint a rapporteur and shall within a maximum period of 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.

1. Within 60 days of receiving a proposed paediatric investigation plan which is valid, the Paediatric Committee shall adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.

Ø recommends that more detailed serious thought be given to the question of access to the territories of Member States for persons in need of international protection and compatibility between stronger protection for these people and respect for the principle of non-refoulement on the one hand and measures to combat illegal immigration, trafficking in human beings and external border control measures on the other; the Commission will enter this item on the agenda for the Immigration and Asylum Committee, where it will ensure that special attention is paid to the question of protected entry procedures on the basis of the results of the s ...[+++]tudy already available and the separate but related problem of resettlement.