EXPLANATORY STATEMENT
Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2017
Subsection 26BB(1), Therapeutic Goods Act 1989
OUTLINE
The Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2017
(the Determination) is a determination made by the Minister under subsection 26BB(l) 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 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 2017, which commenced on 31 January 2017 (referred to as the Previous Determination).
The Determination makes 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 6 new ingredients for use in listed medicines for the first time
The Determination includes references to a number of external documents. In each case, the intention is for the references to relate to those documents ‘as in force or existing from time to time', unless a specific version of the relevant document is identified. The words 'as in force or existing from time to time' are included, as appropriate, throughout the Determination to make it clearer that this is the intention in relation to references to other documents.
Subsection 26BB(8) of the Act provides a contrary intention for subsection 14(2) of the Legislation Act 2003 (the Legislation Act), by allowing a determination under section 26BB to incorporate matter contained in an instrument or other writing as in force or existing from time to time.
In accordance with paragraph 15J(2)(c) of the Legislation Act, the documents referenced in this Determination are described below, together with information relating to how they may be accessed.
The Determination refers to the following New Zealand legislation:
the Animal Products Act 1999 (New Zealand), available free on-line at http://www.legislation.govt.nz/act/public/l 999/0093/latest/DLM33502.html
the Animal Welfare Act 1999 (New Zealand), available free on-line at http://www.legislation.govt.nz/act/public/1999/0142/latest/DLM49664.html
The Determination also refers to the following documents that provide international standards for the safety and quality for ingredients for medicines. A fee is required for access to these documents. It is anticipated that a sponsor of a medicine included in the Australian Register of Therapeutic Goods and other interested persons in the medicines industry using this instrument would be in possession of these standards in order to manufacture the medicine or use the ingredients. Further, versions of these documents are available through a number of libraries allowing public access.
British Pharmacopoeia (BP) (as defined in the Act) available online at: h11I;1s://www.pharmacopoeia.com
European Pharmacopoeia (EP) (as defined in the Act) available on-line at: http://online.pheur.org
United States Pharmacopeia National Formulary (USP-NF) (as defined in the Act) available on-line at: http://vvww.usp.org/usp-nf
Food Chemicals Codex (FCC) published by the United States Pharmacopeial Convention available on-line at http://online.foodchemicalscodex.org
The Determination commenced on the day after it was 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 first determination under subsection 26BB(l) of the Act, the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2015 (the original 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 a standard active, homoeopathic, or 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 with this 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:
• the addition of 6 new ingredients that have been determined to be suitable for inclusion in listed medicines along with associated requirements relating to their use in these products;
• changes to 153 existing ingredient entries, including for example (noting some ingredients required more than one type of change):
- clarification of specific requirements for 50 ingredients, such as removing a requirement that relates to indications where the ingredient is only permitted as an excipient;
- name changes for 10 ingredients, to better align with international standards for approved ingredient names;
- making requirements for 2 ingredients less restrictive, such as reducing the scope of existing requirement to only to apply when ingredient used as excipient;
- changes of the 'purpose of ingredient' for 14 ingredients;
- making requirements for 78 ingredients more restrictive, such as inclusion of a specific requirement for an ingredient which previously had no requirements.
It is expected that updated section 26BB Determinations will be made on a quarterly basis. The need to make timely updates to the Determinations 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. Further, regular updates are necessary to provide industry with accurate and up-to-date information on restrictions for certain ingredients that reflect recent safety data, scientific naming conventions, changes to the Poisons Standard (SUSMP), legislative developments for therapeutic goods, and to correct minor errors. As listed medicines are not prescribed by a doctor and are freely available, there is an imperative to ensure that section 26BB Determinations are accurate, and are 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
Consultation on the policy of making a determination under section 26BB has occurred since late-2014 with key industry bodies, the Australian Self Medication Industry, Complementary Medicines Australia and Accord. This included consultations on the inclusions of permitted ingredients when the first section 26BB Determination commenced on 1 January 2016.
Engagement with industry on changes required in previous section 26BB Determinations and this new Determination has occurred in 2016 and 2017.
Key industry associations were provided with the opportunity to offer comments on the Previous Determination, and these comments have been used to incorporate improvements in this update to the formatting, readability and clarity of wording of requirements for ingredients, and to help ensure that the list is comprehensive and accurate.
A regulatory impact statement is not required for the quarterly updates to the Determination as these updates are minor or machinery in nature. This exemption applies to the addition of permitted ingredients, correction of errors, clarification of requirements and ingredient names, changes to ingredient requirements or availability in order to reflect scheduling decisions contained in the Poisons Standard (SUSMP), or the outcomes of TGA safety evaluations where the regulatory impacts are minor or machinery in nature (Office of Best Practice Regulation Refs. 14416, 20999, and 21645).
The Determination is a legislative instrument for the purposes of the Legislation Act.
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. 2 of 2017
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.2 of 2017
(the Determination) is made by the Minister under subsection 26BB(l) of the Therapeutic Goods Act 1989 (the Act). 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 section 26BB Determination , and that none of the requirements specified in the section 26BB 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) and 29D(l)(b) of the Act 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 2017 (which commenced on 31 January 2017), 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 6 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.
Mayada Kayali, delegate of the Minister for Health