OUTLINE
Therapeutic Goods (Listing) Notice 2015 (No. 4) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of permitting the ingredients named in the Listing Notice for use as therapeutically active ingredients in medicines that are listed on the Australian Register of Therapeutic Goods, subject to the relevant conditions specified in the Listing Notice. The ingredients have not previously been permitted for use and are now permitted for use on the basis that safety and quality evaluation has occurred. The ingredients permitted by this Listing Notices are:
- Ribose
- Calcium Pyruvate and Magnesium Pyruvate
- Octanoic acid
- Terminalia arjuna
- Berberis aristata
- Co-methylcobalamin
- Choline dihydrogen citrate
- Lepidium meyenii
- Trachyspermum ammi
- Dimethylglycine hydrochloride
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
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 that are used in Australia or exported from Australia. One of the controls established by the Act is to require that listed medicines only include ingredients which have been evaluated for safety and quality. Safety and quality are determined by reference to a risk assessment, which considers issues including:
- whether the ingredient is available for use in similar type medicines in other jurisdictions;
- an analysis of relevant literature to identify any potential toxicity issues, relevant poisons standards entries or adverse events;
- any history of use of the ingredient.
Consideration is also given as to whether any conditions are needed to be attached to the use of the ingredient in listed medicines, so that safety and quality can be maintained. Such conditions can include the following:
- how the ingredient is to be used in the medicine, for example as an active or excipient ingredient;
- the method of ingestion, for example topical or oral use;
- appropriate limits on volume or concentration; and
- the inclusion of relevant safety information on product labels, for example allergen advice, or advice about the use of the ingredient for susceptible members of the population such as small children and pregnant women.
CONSULTATION
Consultation was not undertaken in relation to the making of the Listing Notice, as it is considered to be minor and machinery in nature, with low compliance costs for industry. The making of the Listing Notice does not involve any new regulatory steps for industry, but rather provides a basis for products containing any of the ingredients specified in the Notice to access the listing process rather than registration, a significant benefit for sponsors.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices for new ingredients (OBPR Ref. 14416).
STATEMENT OF COMPATIBILITY
This legislative instrument is compatible with human rights as it does not raise any human rights issues. (Statement of Compatibility is included with Supplementary Material).
SUPPLEMENTARY MATERIAL
STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Listing) Notice 2015 (No. 4)
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Bill/Legislative Instrument
Therapeutic Goods (Listing) Notice 2015 (No. 4) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). The Notice has the effect of allowing sponsors of therapeutic goods containing the ingredients named in the Notice to list, rather than register, those goods in the Australian Register of Therapeutic Goods (registration being a considerably more expensive and lengthy process than listing), subject to the conditions described in the Listing Notice.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Rule maker
Trisha Garrett
Delegate of the Minister for Health