English: INTRODUCTION -----------------------------------------------------------------------------------------------------------3 SCOPE -------------------------------------------------------------------------------------------------------------------------3 STRUCTURE OF NEW DRUG SUBMISSIONS ---------------------------------------------------------------------3 PRESENTATION OF THE SUBMISSION ----------------------------------------------------------------------------3 4.1 PRESENTATION ---------------------------------------------------------------------------------------------------------------3 4.1.1 be legible ----------------------------------------------------------------------------------------------------------------3 4.1.2 be easy to access -------------------------------------------------------------------------------------------------------3 4.1.3 be properly paginated -------------------------------------------------------------------------------------------------3 4.1.4 be clearly identified ----------------------------------------------------------------------------------------------------3 4.1.5 contain a table of Contents -------------------------------------------------------------------------------------------3 4.1.6 contain tabs -------------------------------------------------------------------------------------------------------------3 4.2 LANGUAGE--------------------------------------------------------------------------------------------------------------------3 4.3 SUBMISSION COPIES AND IDENTIFICATION OF SUBMISSION VOLUMES ------------------------------------------------3
French: INTRODUCTION --------------------------------------------------------------------------------------------------------- 10 PORTÉE --------------------------------------------------------------------------------------------------------------------- 11 STRUCTURE DES PRÉSENTATIONS DE DROGUE NOUVELLE ------------------------------------------ 11 PRÉSENTATION MATÉRIELLE------------------------------------------------------------------------------------- 12 4.1 PRÉSENTATION ------------------------------------------------------------------------------------------------------------- 12 4.1.1 être lisible ------------------------------------------------------------------------------------------------------------- 12 4.1.2 être facile à consulter------------------------------------------------------------------------------------------------ 12 4.1.3 être correctement paginée ------------------------------------------------------------------------------------------ 12 4.1.4 être clairement identifiée-------------------------------------------------------------------------------------------- 13 4.1.5 contenir une table des matières ------------------------------------------------------------------------------------ 13 4.1.6 contenir des onglets-------------------------------------------------------------------------------------------------- 14 4.2 LANGUE --------------------------------------------------------------------------------------------------------------------- 14 4.3 COPIES ET IDENTIFICATION DES VOLUMES DE LA PRÉSENTATION ---------------------------------------------------- 14 5.