Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) (Cth)

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 and type of incidents reported to Poisons Information Centres and other relevant organisations involving accidental ingestion of medicines containing the substance; (d) the consequences of these incidents (hospital admission or other treatment, serious injury, or death), including the difficulty or complexity of treatment; (e) any special needs of patients who regularly need access to medicines containing the substances, such as older persons or people with a disability; and (f) the technical feasibility and practicality of child‑resistant packaging for medicines containing the substance, taking into account the usual dosage form and presentation. (5) A substance will, in general, be considered to be sufficiently toxic to warrant child‑resistant packaging if the amount contained in a maximum prescription quantity (for example under the Pharmaceutical Benefits Scheme) or the largest retail pack quantity, is likely to produce significant harm (i.e. a requirement for hospital treatment, or death) in a child of 11 kg (i.e. a typical weight of an 18 month old child, representative of the age group in which accidental poisoning is most common). (6) While subsections 4(4) and 4(5) relate to toxicity only from ingestion, if medicines present a hazard in terms of potential to cause serious harm to young children through inadvertent contact with the eyes, skin or mucous membranes, then these medicines will also be considered for child‑resistant packaging. (7) None of the criteria set out in subsection 4(4) are intended to be considered in isolation and recommendations for child‑resistant packaging are made on balance. Consideration of all of the criteria permits the objective assessment of the risk/benefit balance although emphasis will be given to public health and safety. (8) The criteria do recognise that child-resistant packaging can present difficulties for older persons and those with a disability. This also is recognised in each of the Standards for child‑resistance referred to in this Order, which include protocols for testing not only with young children but also with adults who are between 50 and 70 years of age. (9) The forms of packaging permitted by this Order may be either reclosable or non‑reclosable. Requirements for reclosable child‑resistant packages are performance‑based and rely on compliance with at least one of a range of specified national or international Standards, together with a small number of other requirements. (10) At this time, requirements of this Order for non‑reclosable packages such as blister or foil strips do not involve performance testing, but instead are based on design and specified materials of construction. These requirements reflect the general requirements of Australian Standard AS 1928‑2001 Child‑resistant packages. (11) While non-reclosable packaging has been accepted to date as providing a child‑barrier, it is intended that a best practice guideline on this form of packaging will be developed in order to help sponsors improve the robustness and effectiveness of blister or foil strip packaging in order to further reduce the potential for accidental childhood poisoning from medicines packaged in this way.