Source: https://www.tga.gov.au/book/export/html/730188
Timestamp: 2020-05-30 05:51:08
Document Index: 769487999

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 3', 'art 1', 'arts 1']

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders.
There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they're used.
In recognition of this, medicine label requirements are specified in two separate labelling Orders[1]:
In addition to the Orders, other Australian legislation applies to medicine labels. For example, State or Territory legislation for medicines and poisons, and Commonwealth advertising requirements for therapeutic goods.
Guidance on this additional legislation is outside the scope of this document.
On this page: Transition period | How to use this guidance
A four (4) year transition period has been provided for the implementation of TGO 91 and 92 which, together, will eventually replace Therapeutic Goods Order No. 69 - General requirements for labels for medicines (TGO 69).
Specific transition period provisions are described in section 4 of the Orders.
During this time, medicines must comply with either TGO 69 or TGO 91/TGO 92 (whichever is relevant).
Medicines that are released for supply on or after 1 September 2020 (the end of the transition period) must comply with either TGO 91 or TGO 92, whichever is relevant.
In 2017 TGO 69 was remade so that it remains in force during the 4-year transition period.
Sponsors, distributors and retailers can continue to supply TGO 69 compliant goods after 1 September 2020, if those goods were released for supply (the last step in their manufacturing process) on or before 31 August 2020.
We encourage sponsors to transition to the new labelling requirements as soon as possible to reduce confusion for medicine users. The 4 year transition period has been provided so that most labels can be updated well before the end date.
This guidance is not provided as a legal interpretation of TGO 91 or TGO 92. It includes clarification on, and information relating to, the mandatory requirements. It also includes additional information outlining best practice recommendations for medicine labels.
Where the words 'must' or 'required' are used, a legal requirement is being described.
Following this guidance is not a guarantee that your label is fully compliant.
This guidance is divided into four parts.
Part 1 describes the structure of the Orders and legal requirements that generally apply to all medicines.
Part 2 provides guidance to assist you to identify the legal mandatory requirements that apply to certain types of medicines. For each type of medicine, there are references to specific relevant sections of the Orders.
Part 3 provides guidance on the design of medicine labels and some 'best practice principles'. This information is not mandatory, but is included to further improve the safe and quality use of medicines.
Part 4 provides guidance on the tabulated display of Critical Health Information. This includes both mandatory requirements and best practice guidance.
Some medicines are exempt from the Orders, and these are described in section 5 of each Order.
V1.0 Original publication Therapeutic Goods Administration (Scientific Evaluation Branch) 31 August 2016
Corrections based on feedback and clarification of existing information.
Addition of latex labelling in best practice - part 3.
Addition of guidance on determining when a Schedule 1 substance is present - part 1.
Therapeutic Goods Administration (Scientific Evaluation Branch) May 2018
Addition of information about warning statements for neuromuscular blocking agents in parts 1, 2 and 3.
Minor corrections based on stakeholder feedback.
Therapeutic Goods Administration (Scientific Evaluation Branch) June 2018
Additional information to provide clarity on:
Declaration of benzoates
Reference to the CMI for Schedule 1 declarable substances
Multiple barcode guidance
Therapeutic Goods Administration (Scientific Evaluation Branch) July 2019