3 and 16 on reordering the recitals, 6 (2nd part), 11 and 46 (1st and 3rd parts) on the deadline for placing on the market existing medicinal products newly authorised for children, 12 on a recital on a European paediatric form for the collection of data on medicinal products, 13 on a recital on the responsibility of the Paediatric Committee for risk management, 14 and 51 on the removal of the requirement for a medicinal product to be authorised in all Member States, 15 (2nd and 3rd part) on national clinical trials databases, 18 (2nd part) on rare congenital conditions, 19 in terms of reordering the articles and in terms of redrafting (other than on the inventory of therapeutic needs), 23 on the number of representatives of the Commission and of the Executive Director, 24 on interests in the pharmaceutical industry, 25 on the free nature of scientific assistance, 30 on on-going paediatric studies, 32 on the scope of the requirements, 36, 37 and 38 on the submission of paediatric investigation plans, 40 (last part) on deadline for the submission of an amended paediatric investigation plan, 41 on the detailed rules of interaction with the Paediatric Committee, 43 (3rd part) on the paediatric information contained in product information, 44 (2nd part) a European competition to design a logo to be used to label medicines for children, 47, 48, 49 and 83 on pharmacovigilance, 52 (part) on the exclusion of the extension of the supplementary protection certificate for products which have received a patent covering the same paediatric use in the EU, 53 on the number of extensions of the supplementary protection certificate, 54 on a simplified marketing authorisation procedure for orphan drugs, 65 on the harmonisation of national measures enacting penalties, 68 on the deadline for submission of an application for an extension of the supplementary protection certificate, 70 on transitional measures for paediatric investigation plans, 71 on the date of introduction of the requirements.
3 in 16 o prerazporeditvi uvodnih izjav, 6 (drugi del), 11 in 46 (prvi in tretji del) o roku za dajanje v promet obstoječih zdravil, ki so bila za otroke odobrena nedavno, 12 o uvodni izjavi o evropskem pediatričnem obrazcu za zbiranje podatkov o zdravilih, 13 o uvodni izjavi o odgovornosti Odbora za pediatrijo za obvladovanje tveganja, 14 in 51 o črtanju zahteve po odobritvi zdravila v vseh državah članicah, 15 (drugi in tretji del) o nacionalnih bazah podatkov kliničnih preiskav, 18 (drugi del) o redkih prirojenih boleznih, 19 v smislu prerazporeditve členov in spremembe besedila (razen o seznamu terapevtskih potreb), 23 o številu predstavnikov Komisije in izvršnem direktorju, 24 o interesih v farmacevtski industriji, 25 o brezplačnosti znanstvene pomoči, 30 o trenutnih pediatričnih raziskavah, 32 o obsegu zahtev, 36, 37 in 38 o predložitvi načrtov pediatričnih preiskav, 40 (zadnji del) o roku za predložitev spremenjenega načrta pediatričnih preiskav, 41 o natančnih pravilih o vzajemnem delovanju z Odborom za pediatrijo, 43 (tretji del) o pediatričnih podatkih v podatkih o proizvodu, 44 (drugi del) evropski natečaj za oblikovanje loga, ki se bo uporabljal za označevanje zdravil za otroke, 47, 48, 49 in 83 o farmakovigilanci, 52 (del) o izključitvi podaljšanja dodatnega varstvenega certifikata za proizvode, ki so prejeli patent za enako pediatrično uporabo v EU, 53 o številu podaljšanj dodatnega varstvenega certifikata, 54 o poenostavitvi postopka za pridobitev dovoljenja za promet zdravil sirot, 65 o usklajevanju nacionalnih ukrepov v zvezi s kaznimi, 68 o roku za predložitev vloge za podaljšanje dodatnega varstvenega certifikata, 70 o prehodnih ukrepih za načrte pediatričnih preiskav, 71 o datumu uvedbe zahtev.