AUS/169
WTO/TBT
AU Australien
  • 11 - Medizintechnik
2024-07-30
2024-06-04

Medicines

Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety; (54 page(s), in English)

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia.
To support the safe use of medicines, the TGA is proposing to update labelling requirements in the following TGOs:
•    Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
•    Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).
The TGA is conducting a public consultation between 30 May and 11 July 2024 to seek feedback on proposed changes to TGO 91 and TGO 92 to address 3 medicines safety related matters.