Document ID: chunk:federal_register_of_legislation:F2017L01577:front:0:p2
Version: federal_register_of_legislation:F2017L01577
Segment Type: other
Provision Reference: 
Character Range: 2678–5740

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