Draft Order: Packaging Requirements for Specified Therapeutic Products
30 May 2007
Please note: This consultation closed on 13 July 2007.
Written submissions were invited on the following draft Order:
Packaging Requirements for Specified Therapeutic Products (pdf,124kb)
Background
A number of packaging requirements currently applying to therapeutic products regulated in Australia by the Therapeutic Goods Administration (TGA) are specified in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). In broad terms, these packaging requirements relate to the use of 'poisons bottles' for the packaging of therapeutic products containing poisonous substances and impose standards to ensure that this packaging is adequate to reduce the hazard presented to those handling, using, storing or otherwise coming into contact with such products. A similar requirement is applied in New Zealand through the Medicines Regulations 1984, which specifies the use of 'poisons bottles' for the packaging of liquid medicines intended for external use and which have poisonous properties.
The draft Order: Packaging Requirements for Specified Therapeutic Products reflects the transfer of these packaging requirements from the SUSDP in Australia, and the Medicines Regulations 1984 in New Zealand, to the control of the Australia New Zealand Therapeutic Products Authority (ANZTPA).
The draft Order has been developed by the Joint Interim Expert Advisory Committee on Standards (JIEACS) in conjunction with the TGA and Medsafe. It takes account of:
- the recommendation made in the 2001 Australian National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review) for the transfer of all packaging requirements for therapeutic products from the States and Territories to the product regulator; and
- the agreement reached between Australia's National Coordinating Committee on Therapeutic Goods and Medsafe that, in the interests of harmonisation of scheduling, therapeutic products should be removed from Schedules 5 and 6 of the SUSDP, with ANZTPA maintaining equivalent packaging and labelling requirements as previously applied under the SUSDP.
The draft Order also incorporates the current requirement of the SUSDP for medicines classified as 'Controlled Drugs' by the Scheduling Standard (noting that this differs from the meaning of 'Controlled Drug' under the New Zealand Misuse of Drugs Act 1975 and Regulations) to be packaged in such a way that a sealed pack is readily distinguishable from a pack which has been unsealed. This requirement was introduced into the SUSDP to assist in reducing the potential for diversion of these medicines to illicit use or abuse.
URL: http://www.anztpa.org/consult/orders/drpackaging.htm