Child-resistant packaging requirements for therapeutic goods
Consultation papers
4 April 2006
Please note: This consultation closed on 19 May 2006.
The information on this page relates to the following consultation papers:
- Draft Managing Director’s Order Child-Resistant Packaging of Therapeutic Products – Australia New Zealand Therapeutic Products Authority (pdf, 176kb)
- Joint Interim Expert Advisory Committee on Standards - Questions and Answers on Draft Managing Director’s Order on Child-Resistant Packaging (pdf, 34kb)
Background
Child-resistant packaging requirements for therapeutic goods regulated in Australia by the Therapeutic Goods Administration (TGA), and safety packaging requirements for medicines regulated in New Zealand by Medsafe, are specified in Therapeutic Goods Order No. 65 (TGO 65) Child-Resistant Packaging for Therapeutic Goods, and in the Regulations to the Medicines Act (1981), respectively. These requirements can be accessed on the websites of the two agencies.
With the proposed formation of the Australia New Zealand Therapeutic Products Authority (ANZTPA) to regulate therapeutic products in both countries, the Joint Interim Expert Advisory Committee on Standards (JIEACS) recognised the need for development of harmonised standards for the child-resistant packaging (CRP) of therapeutic products. The JIEACS acknowledged that the greatest expertise in CRP matters was held by Australia’s Therapeutic Goods Committee (TGC), and it therefore requested that the TGC undertake the development of harmonised CRP requirements on their behalf. To ensure that the requirements developed would be appropriate for the trans-Tasman environment, the JIEACS stressed the need for relevant New Zealand representation and involvement.
The TGC subsequently established a specialist Subcommittee to undertake this work, drawing on the expertise of Australian and New Zealand members from the therapeutic products industry, poisons information services, and government, as well as the medical and consumer areas. This expert Subcommittee met on three occasions during late 2005 and developed a draft Managing Director’s Order Child-Resistant Packaging of Therapeutic Products setting out proposed, harmonised requirements for the child-resistant packaging of therapeutic products.
The draft Order has since been reviewed by JIEACS, with the JIEACS requesting that it be released for broad stakeholder consultation in Australia and New Zealand. The draft Managing Director’s Order Child-Resistant Packaging of Therapeutic Products is now available for this purpose.