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und Definitionen in Ergänzung zum Österreichischen Impfplan; 1-16; JÄN/2015 2014 Anour, Rene (2014); Biosimilars versus 'biobetters' - a regulator's perspective. Generics and Biosimilars Initiative Journal [...] und neuen Hepatitis-C-Therapeutika, Bedeutung der Warnhinweise für Österreich. Medical Tribune; 2015;16:4 Baumgärtel, Christoph; Substantial savings with generics in Austria - and still room for more. Generic [...] for Hypertension, Hyperlipidemia and Diabetes Mellitus by Equivalent Drug Substitution in Austria. A Nationwide Cohort Study. Appl Health Econ Health Policy. 2015 Apr;13(2):193-205 Heinze, Georg; Jandeck
licence for a proprietary medicinal product transferable? No. In that case, a new application for a marketing authorisation for parallel imports shall be submitted. 4. A parallel import licence for a product [...] at a given time? If so, at what time? 2. Are parallel imports subject to PSUR? 3. Is the parallel import licence for a proprietary medicinal product transferable? 4. A parallel import licence for a product [...] the German "Besonderheitenliste"? In Germany, for example, a lactose warning must be affixed. 13. The primary container (e.g. a syringe) is in a closed tray. Must the tray be opened to open the primary container
reduction of stock be reported multiple times per year? 16. How should a marketing authorisation holder proceed if they want to report, correct, or end a (repeated) temporary reduction of stock? 17. What happens [...] submitted from April 21, within a period of 14 days. Please note that in the event of a revision of the annex, the BASG will not notify marketing authorisation holders if a medicinal product is no longer [...] reporting are available in both German and English. 16. How should a marketing authorisation holder proceed if they want to report, correct, or end a (repeated) temporary reduction of stock? These functions
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