Document ID: chunk:federal_register_of_legislation:F2017L01577:front:0:p1
Version: federal_register_of_legislation:F2017L01577
Segment Type: other
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Character Range: 0–2947

Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017

Therapeutic Goods Act 1989

I, Larry Kelly, delegate of the Minister for Health for the purposes of section 10 of the Therapeutic Goods Act 1989 and acting under that section, determine that the matters specified in this Order constitute a standard for therapeutic goods of the kind described in section 6 of this Order.

Dated 29 November 2017

(Signed by)

LARRY KELLY
Delegate of the Minister for Health

Contents

1 Name of Order
2 Commencement
3 Transition
4 Introduction
5 Interpretation
6 Application
7 Medicines to which this Order does not apply
8 General requirements
9 Reclosable packages
10 Non‑reclosable packages
Schedule 1 Medicines to which this Order applies
Part 1 Classes of substance
Part 2 Individual substances

    1               Name of Order
This Order is the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

    2 Commencement
This Order commences on the day after it is registered.

3 Transition

    (1) From the commencement of this Order up to and including 30 September 2018, each medicine to which this Order applies must comply with either this Order or Therapeutic Goods Order No. 80 - Child‑Resistant Packaging Requirements for Medicines.

    (2) On and from 1 October 2018, each medicine to which this Order applies must comply with this Order.
Note Under the provisions of the Legislation Act 2003, Therapeutic Goods Order No. 80 will sunset on 1 October 2018.

    4 Introduction
    (1) The objective of this Order is to set particular requirements for the packaging of medicines that may present a significant risk of toxicity to children if accidentally ingested.  These requirements relate to child‑resistant packaging — that is, packaging that is designed to be resistant to opening by young children.
    (2) Child‑resistant packaging is not child‑proof.  While it has an important role in reducing the incidence and public health burden of accidental poisoning in children and the associated morbidity and mortality, it provides only one safeguard in that it delays the time taken by a child to open a package and access multiple units, thereby increasing the probability of adult intervention before the contents are fully accessible and can be ingested.
    (3) Compliance of packaging with the national or international Standards for child‑resistance referred to in this Order only establishes a packaging system as child‑resistant, not child‑proof.
    (4) The criteria used to determine whether a substance should be included in Schedule 1 are:
       (a)          the toxicity of the substance contained in the medicine, and risk of harm if it is accidentally ingested by a young child;
       (b)          the extent and patterns of availability in the community of medicines containing the substance;
       (c)          the number