EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 80A AMENDMENTS TO THERAPEUTIC GOODS ORDER NO. 80 CHILD-RESISTANT PACKAGING REQUIREMENTS FOR MEDICINES
Therapeutic Goods Act 1989
Section 10
OUTLINE
Therapeutic Goods Order No. 80A Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines is an Order made by the delegate of the Minister for Health under section 10 of the Therapeutic Goods Act 1989 (the Act).
This Order amends Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80), which was made on 27 August 2008 and registered on the Federal Register of Legislative Instruments on 5 September 2008.
TGO 80A principally amends TGO 80 by extending the range of medicines for which child-resistant packaging (CRP) is required under TGO 80.
TGO 80A commences on 1 October 2013, allowing time for medicines already being supplied or in late development to achieve compliance with the provisions of TGO 80.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (the TGC), a committee established under the Therapeutic Goods Regulations (the Regulations) to advise the Minister on matters relating to standards.
Unless consent is granted by the Secretary under sections 14 and 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with any applicable standard.
TGO 80 requires that medicines containing any of the ingredients specified in that Order be supplied in original packaging that meets specified performance standards for CRP. These performance standards are also specified in TGO 80, and consist of Australian and international standards which set out requirements relating to demonstrating the effectiveness of the packaging in delaying access by children, while also allowing older persons, or those who are less able, to readily access the medicine.
Section 4 of TGO 80 explains the criteria used by the TGC when advising on requirements for CRP for a medicine containing any particular substance. These criteria include, for example, the toxicity of the relevant substances contained in a medicine, the extent and patterns of availability of medicines containing the substance in the community and the number and type of incidents reported to Poisons Information Centres involving such medicines. TGO 80 currently requires that medicines containing 398 specified substances must be packaged in CRP.
At its 35th meeting, held in October 2009, the TGC advised by resolution that stakeholder consultation should be applied in relation to medicines containing any of 23 additional substances.
TGO 80A amends TGO80 to include references to these additional substances, with the effect that medicines containing these substances will be required to be packaged in CRP.
Examples of these additional medicines include oral liquid medicines for the treatment of the symptoms of coughs and colds, and prescription medicines for the treatment of insomnia.
CONSULTATION
Those changes set out in TGO 80A which relate to the application of CRP to cough and cold products, were consulted on with stakeholders in October 2009. The other changes set out in TGO 80A were consulted on with stakeholders in February 2010.
In relation to the cough and cold related measures, these proposals were published on the TGA’s website (www.tga.gov.au), and submissions were invited. In addition, consumer organisations, health practitioner organisations and peak industry bodies were contacted directly about the proposals and consultation. A total of 17 submissions were received, which were broadly supportive of the TGA’s main proposal that oral liquid cough and cold medicines be marketed in CRP.
The consultation on the remaining measures also involved publication of the proposals on the TGA’s website, with submissions invited. Consumer organisations, injury prevention agencies, health practitioner organisations and peak industry bodies were contacted directly. A total of 16 submissions were received. Consideration of these submissions led the TGC to recommend that the concentration threshold of methyl salicylate in liquid medicines above which CRP should be required should be lowered from 25 per cent to 5 per cent, and the Minister’s delegate agreed with that recommendation in making TGO 80A.
In addition to the above, the Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 80A (OBPR reference 13284).