Sch 2
Repeals
Schedule 2—Repeals
Therapeutic Goods (Permissible Indications) Determination (No.1) 2019
1 Name
This instrument is the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019.
//
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Determination sets an authorised list of health claims (permissible indications) that may appear on labels and presentations for listed medicines, and it prescribes the type of evidence and mandatory label or presentation requirements for each claim. It applies to sponsors, manufacturers and advertisers of listed complementary and over‑the‑counter medicines, and matters because it defines what consumer-facing claims are legally allowed and the evidentiary and labelling steps required to use them.
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Direct links to the current provisions in Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019.
Schedule 2—Repeals
Therapeutic Goods (Permissible Indications) Determination (No.1) 2019
1 Name
This instrument is the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under section 26BF of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(b) indications;
(c) label;
(d) medicine;
(e) presentation;
(f) Register; and
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services, as in force or existing at the time this instrument commences.
dentist means a person registered as a dentist under a law of a State or Territory that provides for the registration of dentists.
doctor means a medical practitioner.
Evidence Guidelines means the document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published by the Therapeutic Goods Administration, as in force or existing at the time this instrument commences.
Note: The Evidence Guidelines are published at www.tga.gov.au.
health professional means a person mentioned in section 42AA of the Act.
medically diagnosed, in relation to a disease, ailment, defect or injury, means a disease, ailment, defect or injury that is diagnosed by a suitably qualified medical practitioner.
medical practitioner means a person registered as a medical practitioner under a law of a State or Territory that provides for the registration of medical practitioners.
Regulations means the Therapeutic Goods Regulations 1990.
scientific, in relation to the type of evidence for an indication, means evidence that is based on scientific research and quantifiable data, as described in the Evidence Guidelines.
Note: Scientific evidence includes relevant clinical trials on humans and systematic reviews.
serious, in relation to a form of a disease, ailment, defect or injury, has the same meaning as in section 28 of the Therapeutic Goods Advertising Code, in relation to a form of a disease, condition, ailment or defect.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration’s website which may be accessed on the internet at www.ebs.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Regulations.
traditional, in relation to the type of evidence for an indication, means evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the Evidence Guidelines.
Note: Traditional evidence is a term of broad application and applies to different traditional paradigms, for example, traditional Ayurvedic medicine, traditional Chinese medicine and Western herbal medicine.
traditional Ayurvedic medicine, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the Ayurvedic medicine paradigm.
traditional Chinese medicine or TCM, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the traditional Chinese medicine paradigm.
traditional use has the same meaning as in the Regulations.
5 Permissible indications
The following indications are covered by this instrument under paragraph 26BF(1)(a) of the Act:
(a) each indication specified in an item in column 2 of a table in Schedule 1; and
(b) each indication specified in an item in column 2 of a table in Schedule 1, as modified by the use of one or more qualifying statements set out in the code tables under one of the following headings:
(i) traditional context qualifiers;
(ii) population qualifiers;
(iii) time of use qualifiers;
(iv) in relation to an indication that is based on TCM evidenceTCM pattern qualifiers.
6 Requirements in relation to permissible indications
(1) The requirements in this section are specified in relation to an indication covered by this instrument under paragraph 26BF(1)(b) of the Act.
(2) In relation to a medicine:
(a) the indication mentioned in an item in column 2 of a table in Schedule 1 (the relevant indication) may only be used for the medicine if that indication is supported by evidence of the type that is specified in column 3 of the item; and
(b) the requirements, if any, in relation to the relevant indication, set out in column 4 of that item must be met.
(3) If the wording of an indication is varied on the label of a medicine, then the indication, as varied, must not:
(a) change the meaning or intent of the indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(4) If two or more indications are combined on the label of a medicine to form simple sentences where appropriate in the circumstances, then the indication, as combined, must not:
(a) change the meaning or intent of each indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(5) If an indication in relation to a medicine is modified by one or more qualifying statement in accordance with paragraph 5(b) (whether or not the indication is varied or combined as described in subsection (3) or (4)), then:
(a) each qualifying statement must be set out on the label of the medicine; and
(b) the indication, as modified, varied or combined, must not infer or imply that a medicine is for the treatment of a serious form of a disease, ailment, defect or injury.
(6) If an indication in relation to a medicine is supported by traditional evidence, then:
(a) the indication must be qualified with an appropriate traditional context qualifier as set out in the code tables; and
(b) the traditional context qualifier mentioned in paragraph (a) must be set out on the label of the medicine.
7 Repeals
Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
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Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019
I, Cheryl McRae, as delegate of the Minister for Health, make the following determination.
Dated 13 November 2019
Cheryl McRae
Assistant Secretary
Complementary and Over the Counter Medicines Branch
Health Products Regulation Group
Department of Health
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Permissible indications
6 Requirements in relation to permissible indications
7 Repeals
Schedule 1—Specified permissible indications and requirements applying to these indications when contained in a medicine
Table 1—Indications relating to general health or body parts
Table 2—Indications relating to bone
Table 3—Indications relating to the cardiovascular system
Table 4—Indications relating to the endocrine system
Table 5—Indications relating to the gastrointestinal system
Table 6—Indications relating to the immune system
Table 7—Indications relating to muscles
Table 8—Indications relating to the nervous system
Table 9—Indications relating to nutrition
Table 10—Indications relating to the reproductive system
Table 11—Indications relating to the respiratory system
Table 12—Indications relating to skin
Table 13—Indications relating to the urinary system
Table 14—Traditional Chinese medicine indications
Table 15—Traditional Ayurvedic medicine indications
Schedule 2—Repeals
Therapeutic Goods (Permissible Indications) Determination (No.1) 2019
1 Name
This instrument is the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under section 26BF of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(b) indications;
(c) label;
(d) medicine;
(e) presentation;
(f) Register; and
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services, as in force or existing at the time this instrument commences.
dentist means a person registered as a dentist under a law of a State or Territory that provides for the registration of dentists.
doctor means a medical practitioner.
Evidence Guidelines means the document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published by the Therapeutic Goods Administration, as in force or existing at the time this instrument commences.
Note: The Evidence Guidelines are published at www.tga.gov.au.
health professional means a person mentioned in section 42AA of the Act.
medically diagnosed, in relation to a disease, ailment, defect or injury, means a disease, ailment, defect or injury that is diagnosed by a suitably qualified medical practitioner.
medical practitioner means a person registered as a medical practitioner under a law of a State or Territory that provides for the registration of medical practitioners.
Regulations means the Therapeutic Goods Regulations 1990.
scientific, in relation to the type of evidence for an indication, means evidence that is based on scientific research and quantifiable data, as described in the Evidence Guidelines.
Note: Scientific evidence includes relevant clinical trials on humans and systematic reviews.
serious, in relation to a form of a disease, ailment, defect or injury, has the same meaning as in section 28 of the Therapeutic Goods Advertising Code, in relation to a form of a disease, condition, ailment or defect.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration’s website which may be accessed on the internet at www.ebs.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Regulations.
traditional, in relation to the type of evidence for an indication, means evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the Evidence Guidelines.
Note: Traditional evidence is a term of broad application and applies to different traditional paradigms, for example, traditional Ayurvedic medicine, traditional Chinese medicine and Western herbal medicine.
traditional Ayurvedic medicine, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the Ayurvedic medicine paradigm.
traditional Chinese medicine or TCM, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the traditional Chinese medicine paradigm.
traditional use has the same meaning as in the Regulations.
5 Permissible indications
The following indications are covered by this instrument under paragraph 26BF(1)(a) of the Act:
(a) each indication specified in an item in column 2 of a table in Schedule 1; and
(b) each indication specified in an item in column 2 of a table in Schedule 1, as modified by the use of one or more qualifying statements set out in the code tables under one of the following headings:
(i) traditional context qualifiers;
(ii) population qualifiers;
(iii) time of use qualifiers;
(iv) in relation to an indication that is based on TCM evidenceTCM pattern qualifiers.
6 Requirements in relation to permissible indications
(1) The requirements in this section are specified in relation to an indication covered by this instrument under paragraph 26BF(1)(b) of the Act.
(2) In relation to a medicine:
(a) the indication mentioned in an item in column 2 of a table in Schedule 1 (the relevant indication) may only be used for the medicine if that indication is supported by evidence of the type that is specified in column 3 of the item; and
(b) the requirements, if any, in relation to the relevant indication, set out in column 4 of that item must be met.
(3) If the wording of an indication is varied on the label of a medicine, then the indication, as varied, must not:
(a) change the meaning or intent of the indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(4) If two or more indications are combined on the label of a medicine to form simple sentences where appropriate in the circumstances, then the indication, as combined, must not:
(a) change the meaning or intent of each indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(5) If an indication in relation to a medicine is modified by one or more qualifying statement in accordance with paragraph 5(b) (whether or not the indication is varied or combined as described in subsection (3) or (4)), then:
(a) each qualifying statement must be set out on the label of the medicine; and
(b) the indication, as modified, varied or combined, must not infer or imply that a medicine is for the treatment of a serious form of a disease, ailment, defect or injury.
(6) If an indication in relation to a medicine is supported by traditional evidence, then:
(a) the indication must be qualified with an appropriate traditional context qualifier as set out in the code tables; and
(b) the traditional context qualifier mentioned in paragraph (a) must be set out on the label of the medicine.
7 Repeals
Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.
Schedule 1—Specified permissible indications and requirements applying to these indications when contained in a medicine
Note: See sections 5 and 6.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Product presentation must not imply or refer to drugs/alcohol.
Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.
Label statement: Not to be used in children under 5 years.
Product presentation must not imply or refer to serious conditions associated with alopecia e.g. autoimmune disease, chemotherapy.
Product presentation must not imply or refer to recurrent or persistent mouth lesions.
Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.
This is an opening excerpt, not the complete document.