Reminder to sponsors - child-resistant packaging requirements

15 August 2007

Sponsors are reminded that requirements for the child resistant packaging of therapeutic goods are given in Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods (TGO 65) <http://www.tga.gov.au/docs/html/tgo/tgo65.htm>.

TGO 65 incorporated a transition period to allow sponsors to achieve compliance with the revised requirements included in this Order.

This transition period ended on 30 June 2007, and the previous Orders relating to child-resistant packaging (TGO 20 and TGO 33) have been revoked.

The First Schedule to TGO 65 identifies the ingredients of therapeutic goods which result in a mandatory requirement for child-resistant packaging for the final product, unless the product falls into one of the exemption categories described in the Order.

TGO 65 also specifies the forms of packaging that will satisfy the requirement for child-resistant packaging and the performance requirements this packaging is to meet.

Sponsors should note that TGO 65 requires sponsors to hold evidence that the specified performance requirements are met. This evidence must relate to the particular packaging system used.

It also should be noted that for reclosable forms of packaging, the required evidence goes beyond establishing compliance with the child and adult test protocols given in the national and/or international Standards listed in subclause 4(1) of the Order, or that the packaging used is referenced in the Second Schedule.

The evidence required by TGO 65 may be called in for evaluation or review at any time.