EXPLANATORY STATEMENT
Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2016
Subsection 26BB(1), Therapeutic Goods Act 1989
The Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2016 (the Determination) is a determination made by the Minister under subsection 26BB(1) of the Therapeutic Goods Act 1989 (the Act) and has the effect of 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 medicines.
The Determination is also intended to succeed (i.e. revoke and replace) the previous Determination which specified ingredients and related requirements for such medicines - the Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015, which commenced on 1 January 2016 (the previous Determination).
The Determination will commence on the day after it is registered on the Federal Register of Legislation.
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 medicines that are listed in the Register under section 26A of the Act (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 relevant medicine.
Prior to the making of the previous Determination, ingredients were authorised for use in listed medicines generally through the list of ingredients 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).
The Determination, however, provides for a single, comprehensive list of ingredients permitted for use in listed medicines, along with requirements applying to the use of particular ingredients included in listed medicines.
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 purpose of the Determination is to revoke and replace the previous Determination – the Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015, which commenced on 1 January 2016 - with a new Determination that includes new ingredients that will be available for use in listed medicines, and that also incorporates a number of other changes to the previous Determination.
These changes include:
- adding 30 ingredients for use in listed medicines, along with associated requirements relating to their use in these products – for example, pine needle oil terpeneless is included and permitted for use if in combination with other permitted ingredients as a flavour or fragrance and subject to certain total flavour or fragrance concentration limitations, and petitgrain mandarin oil has been included and permitted for use if in combination with other permitted ingredients as a flavour and subject to a certain total flavour concentration limitation;
- making changes to the requirements relating to the use of some ingredients approved for use in listed medicines, principally in order to: correct unintended errors in the previous Determination and to clarify a number of existing requirements (without changing their effect) to make them clearer;
- removing references to some of the purposes for which a number of existing ingredients may be used in listed medicines, or to add new such purposes; and
- updating a number of ingredient names, as part of moving to internationally accepted terminology for ingredient naming – this is designed to, among other things, assist health professionals and the public to compare similar therapeutic goods and to avoid confusion between goods.
Examples of the changes to ingredient requirements in the Determination include changes to specify a requirement for listed medicines containing peanut in the Determination for the first time, to more clearly identify that the medicine contains that ingredient. This will not involve any new requirements for sponsors, but will bring the ingredient requirements for listed medicines with peanut into line with the requirements that existed immediately prior to the commencement of the previous Determination.
Changes are also included in relation to the requirements for Black cohosh (in powder or dry form), to replace an outdated warning statement that was inadvertently included in the previous Determination, and for thujone, to specify that it is a mandatory component of a number of ‘Artemisia’ ingredients, but that the concentration of thujone in listed medicines containing those ingredients must be no more than 4 per cent. In both of these cases, the effect of the changes will be to bring the Determination into line with the requirements that applied to such ingredients before the making of the previous Determination.
Where changes have been made to remove certain purposes for which several ingredients may be used in a listed medicine. This has also been in order to bring the Determination into line with the range of available uses that applied to those ingredients before the making of the previous Determination. For example, tannic acid was inadvertently made available for use as an active ingredient in the previous Determination. In this case, the purpose for which the ingredient is permitted for use has been changed and is now only permitted for use as a homoeopathic preparation ingredient or excipient ingredient.
It is expected that updated Determinations will be made on a quarterly basis - the need to make timely updates to the Determination available arises for a number of reasons, including to ensure that new ingredients requested by industry are made available for use in listed medicines as soon as possible after they have been assessed or determined to be safe. In addition, as listed medicines are not prescribed by a doctor and are freely available, there is an imperative to ensure that the Determination is accurate, and is routinely maintained, so as to provide clear requirements for industry about what ingredients can be safely used in listed medicines and, about what safety information needs to be provided to consumers on product labels to ensure the safe use of those products by the public.
CONSULTATION
Extensive consultation was undertaken with industry in 2015 in the lead up to making the previous Determination. The majority of changes in the Determination have been made to correct inadvertent errors and to bring ingredient requirements into line with those that existed before the making of the previous Determination.
Consultation has continued in early 2016 on the range of changes proposed to be made to the previous Determination, through face-to-face briefings, teleconferences and written correspondence. Key industry associations were provided with the opportunity to offer comments on the previous Determination, and these comments have been used to incorporate improvements to the formatting and readability of the Determination and to the wording of the requirements for ingredients, and also to help ensure that the list is comprehensive and accurate. Engagement with industry on the implementation of the Determination is also ongoing.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to addition of permitted ingredients (OBPR Ref. 14416), or in relation to changes to the Determination to correct errors, clarify requirements or remove outdated ingredient names (OBPR Ref. 20672).
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 2016
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 2016 (the Determination) is made by the Minister under subsection 26BB(1) of the Therapeutic Goods Act 1989. The Determination has the effect of 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 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 false or misleading 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).
The Determination revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 (which commenced on 1 January 2016), and incorporates a number of changes to the previous Determination. These include, for example, correcting a number of unintended errors, making a number of requirements relating to the use of particular ingredients clearer and introducing 30 new ingredients for use in listed medicines for the first time.
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.
Larry Kelly, delegate of the Minister for Health