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if I make use of the transitional provision of Section 16b of the German Medicines Act (AMG) for my medicinal product and therefore use the SmPC as a package insert instead of the package leaflet? 7. Do [...] Gazette I No. 146/2009, entered into force, and with it the Art 16 para 4 (2) AMG. Excerpt from the Austrian Medicinal Products Act [Art 16 para 4 (2)]:* ‘In addition to the information provided in accordance [...] medicinal products are affected by the legal requirements? In principle, Art 16 para 5 (4) applies to all medicinal products containing a substance listed in Annex I of the International Convention against Doping
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