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38 result(s) found, displaying 26 to 38
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Corporate reportsIn 2019, the TGA conducted 10 pharmacovigilance inspections of Australian medicine sponsors
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Corporate reportsThis report describes the first 12 months of the mandatory reporting scheme
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Corporate reportsNew chemical entities registered in 2017 in Australia.
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Scheduling decisions (final)Final decisions for substances referred to the ACMS, ACCS/ACMS, ACCS November 2017 meetings, and delegate only decisions on agricultural and veterinary chemicals and NCEs.
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Corporate reportsReport detailing prescription medicines registrations for 2017
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Corporate reportsNew generic medicines and biosimilar medicines registered in 2017
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Scheduling decisions (final)Final decisions for medicines and chemicals referred to March 2017 scheduling meetings (ACMS #20, ACCS #19 and Joint ACMS-ACCS #15) and NCEs.
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Corporate reportsSummary of generic and biosimilar prescription medicines registered in Australia in 2016
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Corporate reportsThese annual summaries provide details of new prescription medicines registrations and information on new or extended uses for existing medicines.
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Corporate reportsEach year, approximately 40 new prescription medicines containing new active substances are registered.
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Corporate reportsThis statement guides decision making to help address concerns with joint replacement prostheses.
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Corporate reportsFind out when software is classified as an in vitro medical device and how it is regulated.
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Corporate reportsThis Code supersedes the November 1991 edition of the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use.