FAQ third country inspections New

Can the BASG inspect the manufacture of an active substance in a third country? New

Yes, although certain conditions must be met. Ideally, further processing into the finished product should take place at an Austrian production site (value-added activity). Another option is available provided that the active substance in question is included in the currently valid EU list of critical medicines (Union list of critical medicines | European Medicines Agency (EMA)). The mere fact that an active substance is contained in a medicinal product authorised in Austria is not sufficient.

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