Child resistant packaging requirements for therapeutic goods are currently regulated in Australia by the Therapeutic Goods Administration under Therapeutic Goods Order No. 65 (TGA65) - Child Resistant Packaging for Therapeutic goods. In New Zealand the area is overseen by Medsafe under the Regulations to the Medicines Act (1981). The recent draft order addressing child resistant packaging of therapeutic products is the result of an attempt to harmonise Australian and New Zealand standards in this regard.
What will the draft Order mean for the industry?
The objective of the Order is to set requirements for packaging of therapeutic products that may present a significant risk of toxicity to children if accidentally ingested. In particular, the draft Order addresses the regulation of packaging which is designed to be resistant to opening by children, and broadens the scope of the Order as it currently stands in the following ways:
the application of the original Order is extended to include not only therapeutic products that contain a "substance" specified in the First Schedule to the Order or "salt, ester or other derivative of a substance" contained in the First Schedule (cl 2(1)(a)); but also therapeutic products containing a "substance, or a salt, ester or other derivative of a substance that can be classified as belonging to a class of substance" as specified in the First Schedule (cl 2(1)(b)). The number of products covered by the draft Order are hence substantially greater than the current standard; and
the draft Order provides that even if the therapeutic product does not contain a substance specified in the First Schedule, such products will come within the operation of the Order where it is presented as child resistant through its labelling or packaging, whether expressly or by implication.
Submissions to comment on the draft Order have been requested by 19 May 2006.
The Australian Competition and Consumer Commission proposes reauthorising drug company code
A new edition of the Medicines Australia Code of Conduct governing drug companies' dealings with doctors ("the Code"), has been developed after the Australian Competition and Consumer Commission ("ACCC") proposed to reauthorise the Code for another period of three years. The current Code is in its 14th edition and took effect from 1 January 2003.
The Code governs the activities of pharmaceutical companies promoting prescription medicines to doctors. It regulates the advertising of prescription drugs to the medical profession and contains provisions regarding the drug company sponsorship of medical conferences; the payment of travel and accommodation expenses of doctors attending such conferences; and the provision of other forms of hospitality. The ACCC has responsibility for ensuring that such voluntary marketing codes deliver a net public benefit.
The amended Code shall contain some improvements, in particular concerning the level of transparency around the provision of benefits to healthcare professionals by companies. The ACCC will now engage in a further round of public consultation before proceeding to make a final decision about the implementation of the amended Code.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
What happens if a patient, particularly a mental health patient,.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).