TBT BSN | Notification

Notification Detail :: G/TBT/N/AUS/169

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety

Objective

Consumer information, labelling (TBT); Protection of human health or safety (TBT)

Product Covered

Medicines

Document Notification

Link to ePing

HSCODE

30 - PHARMACEUTICAL PRODUCTS

ICSCODE

11.120 - Pharmaceutics

Keywords

Labelling

Specific Regions

Description

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.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/AUS/169

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