EXPLANATORY STATEMENT
Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015
Subsection 26BB(1), Therapeutic Goods Act 1989
OUTLINE
The Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 (the Determination) is a determination made by the Minister under subsection 26BB(1) of the
Therapeutic Goods Act 1989 (the Act). Subsection 26BB(1) of the Act authorises the Minister to make a legislative instrument specifying ingredients that may be contained in a medicine listed in the Australian Register of Therapeutic Goods (the Register) under section 26A of the Act, and requirements in relation to the inclusion of those ingredients in such medicine.
The Determination specifies both ingredients and requirements for the purposes of subsection 26BB(1).
The Determination will commence on 1 January 2016.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the Act.
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, and that consideration has been given to whether any conditions should be attached to the use of the ingredient, so that safety and quality can be maintained. The Determination supports the achievement of this control by providing for a list of ingredients which have been assessed or determined previously to be safe, and providing for the requirements applying to particular ingredients when contained in a medicine. The Determination can be varied in the future to include new ingredients proposed for listed medicines or new requirements applying to a particular ingredient when contained in a listed medicine. However, in deciding to make a variation to the current determination, the Minister must have regard to the quality and safety of the ingredient concerned.
Prior to the Determination, ingredients were authorised for use in listed medicines generally through the list of therapeutic goods in Schedule 4 to the Therapeutic Goods Regulations 1990, or through notices made by the Minister under subsection 9A(5) of the Act (Listing Notices). In addition, ingredients or substances that are not listed in a Schedule to the current Poisons Standard, or excluded from the scope of the Poisons Standard can be ingredients or substances that can be contained in a listed medicine. The exclusion from the scope of the Poisons Standard could be by way of the concentration of the ingredient or substance in a particular dosage form or through other requirements.
The Determination, however, will provide for a single, comprehensive list of ingredients permitted for use in listed medicines, along with requirements applying to particular ingredients included in this list.
It is important to note that all listed medicine ingredients that have previously been approved by the TGA will be included in the Determination – no ingredients will be left out of the new instrument.
The requirements imposed under the Determination principally relate to ensuring the quality and safety of the ingredient when used. Requirements may relate, for example, to:
- how the ingredient is to be used in the medicine, for example as an active or an excipient ingredient;
- the method of ingestion or application, for example oral or topical use;
- the source of the ingredient, or the method of manufacture;
- appropriate limits on volume or concentration of the ingredient contained in the medicine; 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.
The Determination includes a Table at Schedule 1 to the Determination which provides for the list of ingredients that can be contained in listed medicines at column 2, the particular use or purpose of the ingredients in the medicine at column 3 and the requirements applying to the ingredients when used in a medicine at column 4. The particular use or purpose of the ingredient can be as an active ingredient, excipient or homeopathic prepared ingredient. The Determination also provides for additional requirements applying to ingredients specified in Table 1, where these specified ingredients are derived from animal origins.
In addition to providing industry, consumers and healthcare professionals with access to a ”one-stop shop” list of permissible ingredients able to be used in listed medicines, a person seeking to list a medicine in the Register under section 26A of the Act must certify, when doing so, that the medicine does not contain an ingredient that is not specified in the Determination, and that none of the requirements specified in the Determination in relation to the ingredients contained in the medicine have been contravened – paragraphs 26A(2)(ca) and (cb) of the Act refer.
If a person incorrectly certifies as to these matters, the Secretary may cancel, or suspend, their goods from the Register (paragraphs 30(1)(e) of the Act and 29D(1)(b) refer). Offences, and civil penalty provisions may also apply if a person makes a statement in, or in connection with, a certification of a matter under subsection 26A(2) of the Act (including in relation to permissible ingredients and related requirements).
CONSULTATION
Complementary Medicines Australia (CMA) and the Australian Self Medication Industry (ASMI) were consulted at the time that amendments were made to the Act in 2010 to introduce the current section 26BB to the Act.
The TGA has consulted with industry on the legislative and administrative processes relating to the making of the Determination through face-to-face briefings, teleconferences and written correspondence. Key industry associations (Australian Self Medication Industry, Complementary Medicines Australia and ACCORD) have been provided with a copy of the list of ingredients and requirements, and have been provided with the opportunity to offer comments on the list. These comments have been used to make improvements to the formatting and wording of the requirements, and to ensure that the list is comprehensive and accurate. Engagement with industry on the implementation of this legislative instrument is ongoing.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to the determination made by the Minister specifying the ingredients that be contained in listed medicines under section 26A of the Act and any applicable requirements applying to particular ingredients being contained in a listed medicine (OBPR ID: 16040).
The Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
In relation to compatibility with human rights, it is considered that the Determination 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, and a Statement of Compatibility setting that out in further detail is below.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS 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 (Permissible Ingredients) Determination No. 1 of 2015
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 Legislative Instrument
The Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 (the Determination) is made by the Minister under subsection 26BB(1) of the Therapeutic Goods Act 1989. The Determination has the effect of permitting the ingredients described in the Determination, subject to the requirements described in the Determination for an ingredient, to be contained in medicines listed or to be listed on the Australian Register of Therapeutic Goods.
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.
Mary McDonald, delegate of the Minister for Health