Traducción de «Suspensión del estudio de la solicitud » (Español → Inglés) :

(e) "examination of an asylum application" means any examination of, or decision or ruling concerning, an application for asylum by the competent authorities in accordance with national law except for procedures for determining the Member State responsible in accordance with this Regulation;

(i) either that the medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the holder of the marketing authorization for the original medicinal product has consented to the toxicological, pharmacological and/or clinical references contained in the file on the original medicinal product being used for the purpose of examining the application in question.

Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.

(i) either that the veterinary medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the marketing authorization holder has agreed that the toxicological, pharmacological and/or clinical references contained in the file on the original veterinary medicinal product may be used for the purpose of examining the application in question.

Whereas in order better to protect public health and avoid any unnecessary duplication of effort during the examination of application for authorization to place medicinal products on the market, Member States should systematically prepare assessment reports in respect of each medicinal product which is authorized by them, and exchange the reports upon request; whereas, furthermore, a Member State should be able to suspend the examination of an application for authorization to place a medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by t ...[+++]he latter Member State;

Whereas in order better to protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for authorization to place veterinary medicinal products on the market, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request; whereas, furthermore, a Member State should be able to suspend the examination of an application for authorization to place a veterinary medicinal product on the market which is currently under active consideration in another Member State with a vi ...[+++]ew to recognizing the decision reached by the latter Member State;