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An example of such a dossier is provided in Fig. 2.
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Full dossiers were provided for 6%% of the applications, bibliographic applications accounted for 4%% and the remaining 2%% concerned other applications (see Table S1).
For an early benefit assessment according to § 35a SGB V, the main source is a dossier that is provided by the drug manufacturer.
Some methodological specifications are provided in the dossier template (Section 4.2.5.6 Suppl. G-BA VerfO).
The quality standard of biofertilisers shall include parameters which can be listed in the label or that will be required to be provided in the dossier for the authorisation for marketing.
Further, no commercial site stability data was provided in the registration dossiers submitted to markets that required this data.
Otherwise, proof of additional benefit is not considered to have been provided due to an incomplete dossier (§9 par. 3 G-BA VerfO; § 35a par. 1 SGB V).
Although this was provided by the manufacturer in a revised dossier, the G-BA concluded that it was obsolete for methodological reasons and the initially assigned additional benefit rating was not changed [8].
The analysis of this subpopulation was provided by the company in the AMNOG dossier, and thus the results on the benefit and harms of ticagrelor in this population are now publicly available.
In the dossiers submitted for early benefit assessment, analyses of these subpopulations can be provided by the pharmaceutical companies on the basis of individual patient data.
For 21 biocidal products with complete dossiers available from the regulatory authorization process in the EU, confidential information on product composition and a base set of data were provided by the German Environment Agency.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com