This Act has been repealed and is no longer in force. It is retained for historical reference.
Jurisdiction
Commonwealth
Collection
legislative instrument
Plain English Summary
7/10 complexity
This instrument specifies an exhaustive list of permissible indications that may appear on labels or presentations for listed (mainly complementary and over‑the‑counter) medicines, and sets the type of supporting evidence and mandatory label/presentation requirements for each indication. It operates under the Therapeutic Goods Act and repeals the 2018 determination. Sponsors pay the compliance costs (evidence, labelling changes); the TGA/delegate decides which indications and qualifiers are allowed and how claims may be worded.
Zoe can write the in-depth analysis on top of the summary above: how it works, who it affects and what each part actually does.
Current sections
Direct links to the current provisions in Therapeutic Goods (Permissible Indications) Determination (No.1) 2019.
7
2
Commencement
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.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument The day after registration.
Note: This table relates only to the provisions of this instrument as originally made.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
3 Authority
This instrument is made under subsection 26BF(1) of the Therapeutic Goods Act 1989.
4
Definitions
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
health practitioner;
health professional;
(b) indications;
(c) label;
(d) medicine;
(e) presentation;
(f) Register;
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989
Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at www.ebs.tga.gov.au under the heading “Public TGA Information”, as at the commencement of this instrument.
Dentist means a person who is registered under the Health Practitioner Regulation National Law in the dentistry profession.
Doctor means a medical practitioner.
Evidence guidelines means the TGA document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published on the TGA’s website (www.tga.gov.au), as at the commencement of this instrument.
Medically diagnosed, in relation to a disease, condition, ailment or defect, is where the disease, condition, ailment or defect has been diagnosed by a suitably qualified medical practitioner.
Medical practitioner means a person who is registered under the Health Practitioner Regulation National Law in the medical profession.
Regulations mean the Therapeutic Goods Regulations 1990.
Scientific means a scientific indication.
Scientific indication means an indication that is supported by scientific evidence, such as clinical studies or systematic reviews, as described in the Evidence guidelines.
Serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.
TGA means the Therapeutic Goods Administration.
Traditional means a traditional indication.
Traditional Ayurvedic medicine means a traditional Ayurvedic medicine indication.
Traditional Ayurvedic medicine (TAY) indication means a traditional indication that is based on traditional use in the Ayurvedic medicine paradigm.
Traditional Chinese medicine means a traditional Chinese medicine indication.
Traditional Chinese medicine (TCM) indication means a traditional indication that is based on traditional use in the traditional Chinese medicine paradigm.
Traditional indication means an indication that is supported by evidence of traditional use, as described in the Evidence guidelines.
Traditional use has the same meaning as in the Regulations.
5
Permissible indications and requirements applying in relation to those indications
5 Permissible indications and requirements applying in relation to those indications
Permissible indications in Tables 1 to 15
The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument are specified for the purposes of paragraph 26BF(1)(a) of the Act.
The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument when modified using the qualifying statements in the Code Tables under the headings:
‘Traditional context qualifier’;
‘Population qualifiers’;
‘Time of use qualifiers’; or
for TCM indications, ‘TCM pattern qualifiers’;
are also specified for the purposes of paragraph 26BF(1)(a) of the Act.
Requirements for permissible indications
(3) For the purposes of paragraph 26BF(1)(b) of the Act, the indications specified under subsections 5(1) and 5(2) are subject to the following requirements:
(a) they may only be used for a medicine if supported by the type of evidence specified in column 3 of Tables 1 to 15 in Schedule 1; and
(b) they must comply with the requirements set out in column 4 of Tables 1 to 15 in Schedule 1; and
(c) where:
the wording of an indication is varied on the label of a medicine; or
where more than one indication is used and they are combined on the label of a medicine to form simple sentences where appropriate; or
both (i) and (ii);
then:
the meaning of the indication must not be changed; and
the varied or combined indications must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury; and
the varied or combined indications must not infer or imply that a medicine is for preventing or curing a disease, ailment, defect or injury;
(d) where an indication in column 2 of Tables 1 to 15 in Schedule 1 to this instrument is modified using a qualifying statement in the Code Tables as mentioned in subsection 5(2) and where that indication, including as varied or combined with another indication, is used on the medicine’s label:
the qualifying statement must also be included on the medicine’s label; and
the modified indication, including as varied or combined with another indication, must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury
(e) A medicine using traditional indications must also comply with the following requirements:
(i) the traditional indication must be qualified with an appropriate “Traditional context qualifier” from the Code Tables; and
(ii) the “Traditional context qualifier” from the Code Tables must be included on the label of the medicine.
6
Repeals
6 Repeals
Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.
More sections below
Source text: opening excerpt
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
I, Cheryl McRae, as delegate of the Minister for Health, make the following determination.
Dated 28/2/2019
Cheryl McRae
Assistant Secretary
Complementary and Over the Counter Medicines Branch
Medicines Regulation Division
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Permissible indications and requirements applying in relation to those indications
6 Repeals
Schedule 1 - Specified permissible indications and requirements applying to these indications when used for a medicine
Schedule 2 – Repeals
1 Name
This instrument is the Therapeutic Goods (Permissible Indications) Determination (No.1) 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.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument The day after registration.
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.
This instrument is made under subsection 26BF(1) 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:
health practitioner;
health professional;
(b) indications;
(c) label;
(d) medicine;
(e) presentation;
(f) Register;
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989
Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at www.ebs.tga.gov.au under the heading “Public TGA Information”, as at the commencement of this instrument.
Dentist means a person who is registered under the Health Practitioner Regulation National Law in the dentistry profession.
Doctor means a medical practitioner.
Evidence guidelines means the TGA document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published on the TGA’s website (www.tga.gov.au), as at the commencement of this instrument.
Medically diagnosed, in relation to a disease, condition, ailment or defect, is where the disease, condition, ailment or defect has been diagnosed by a suitably qualified medical practitioner.
Medical practitioner means a person who is registered under the Health Practitioner Regulation National Law in the medical profession.
Regulations mean the Therapeutic Goods Regulations 1990.
Scientific means a scientific indication.
Scientific indication means an indication that is supported by scientific evidence, such as clinical studies or systematic reviews, as described in the Evidence guidelines.
Serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.
TGA means the Therapeutic Goods Administration.
Traditional means a traditional indication.
Traditional Ayurvedic medicine means a traditional Ayurvedic medicine indication.
Traditional Ayurvedic medicine (TAY) indication means a traditional indication that is based on traditional use in the Ayurvedic medicine paradigm.
Traditional Chinese medicine means a traditional Chinese medicine indication.
Traditional Chinese medicine (TCM) indication means a traditional indication that is based on traditional use in the traditional Chinese medicine paradigm.
Traditional indication means an indication that is supported by evidence of traditional use, as described in the Evidence guidelines.
Traditional use has the same meaning as in the Regulations.
5 Permissible indications and requirements applying in relation to those indications
Permissible indications in Tables 1 to 15
The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument are specified for the purposes of paragraph 26BF(1)(a) of the Act.
The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument when modified using the qualifying statements in the Code Tables under the headings:
‘Traditional context qualifier’;
‘Population qualifiers’;
‘Time of use qualifiers’; or
for TCM indications, ‘TCM pattern qualifiers’;
are also specified for the purposes of paragraph 26BF(1)(a) of the Act.
Requirements for permissible indications
(3) For the purposes of paragraph 26BF(1)(b) of the Act, the indications specified under subsections 5(1) and 5(2) are subject to the following requirements:
(a) they may only be used for a medicine if supported by the type of evidence specified in column 3 of Tables 1 to 15 in Schedule 1; and
(b) they must comply with the requirements set out in column 4 of Tables 1 to 15 in Schedule 1; and
(c) where:
the wording of an indication is varied on the label of a medicine; or
where more than one indication is used and they are combined on the label of a medicine to form simple sentences where appropriate; or
both (i) and (ii);
then:
the meaning of the indication must not be changed; and
the varied or combined indications must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury; and
the varied or combined indications must not infer or imply that a medicine is for preventing or curing a disease, ailment, defect or injury;
(d) where an indication in column 2 of Tables 1 to 15 in Schedule 1 to this instrument is modified using a qualifying statement in the Code Tables as mentioned in subsection 5(2) and where that indication, including as varied or combined with another indication, is used on the medicine’s label:
the qualifying statement must also be included on the medicine’s label; and
the modified indication, including as varied or combined with another indication, must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury
(e) A medicine using traditional indications must also comply with the following requirements:
(i) the traditional indication must be qualified with an appropriate “Traditional context qualifier” from the Code Tables; and
(ii) the “Traditional context qualifier” from the Code Tables must be included on the label of the medicine.
6 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 used for a medicine
(section 5)
Table 1 – Indications relating to general health / body parts
Column 1 Column 2 Indication Column 3 Type of evidence Column 4 Other requirements
1 Aid/assist in the healing of minor body tissue injuries Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
2 Aid/assist nail growth Scientific or Traditional
3 Aid/assist/help/maintain healthy hair follicles Scientific or Traditional
5 Aids/assists abdominal fat loss Scientific If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.
6 Aids/assists body waste elimination Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
7 Aids/assists body's natural channels of elimination Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
8 Aids/assists excretion of metabolic waste products Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
9 Aids/assists eye adaption to variations in light intensity/night vision Scientific or Traditional Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.
10 Aids/assists gum development Scientific
11 Aids/assists gum healing Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
12 Aids/assists head lice and egg removal Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.
13 Aids/assists natural body cleansing/detoxification processes Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
14 Aids/assists natural cleansing/detoxification processes of the gastrointestinal system/gut Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
15 Aids/assists natural kidney cleansing/detoxification processes Scientific or Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
16 Aids/assists teeth development Scientific
17 Aids/assists with recovery from illness/convalescence Scientific or Traditional Product presentation must not imply or refer to imply chronic fatigue syndrome.
18 Alterative/blood cleanser/depurative/purifier Traditional Product presentation must only refer to detoxification in relation to natural body processes.
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.
19 Analgesic/Anodyne/relieve pain Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
20 Anti-inflammatory/relieve inflammation Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
21 Antioxidant/Reduce free radicals formed in the body Scientific
22 Antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Label statement: Not to be used in children under 5 years.
23 Astringent/tightens tissues Traditional
24 Body tonic Traditional
25 Decrease/reduce bacteria in the mouth Scientific Product presentation must not imply or refer to serious infections.
26 Decrease/reduce ear irritation/inflammation Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
27 Decrease/reduce ear wax Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
28 Decrease/reduce hair loss/thinning Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Product presentation must not imply or refer to serious conditions associated with alopecia e.g. autoimmune disease, chemotherapy.
29 Decrease/reduce halitosis/bad breath Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
30 Decrease/reduce nail brittleness/splitting/chipping Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
31 Decrease/reduce/relieve cracks in the corner of the mouth Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Product presentation must not imply or refer to recurrent or persistent mouth lesions.
32 Decrease/reduce/relieve excessive perspiration/sweating Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
33 Decrease/reduce/relieve eye strain Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
34 Decrease/reduce/relieve gum soreness/pain/discomfort Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
35 Decrease/reduce/relieve itchiness associated with head lice infestation Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.
36 Decrease/reduce/relieve mouth/oral mucosa mild inflammation Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
37 Decrease/reduce/relieve spontaneous sweating Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
38 Decrease/reduce/relieve symptoms of mild mouth ulcers Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
Product presentation must not imply or refer to recurrent or persistent mouth lesions.
Product presentation must only refer to mild mouth ulcers.
39 Decrease/reduce/relieve symptoms of dehydration Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
40 Decrease/reduce/relieve symptoms of jet lag Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
41 Decrease/reduce/relieve symptoms of mild temporomandibular joint dysfunction diagnosed by a doctor or dentist Scientific or Traditional Label statement: If symptoms persist or worsen talk to your medical practitioner.
Product presentation must only refer to mild temporomandibular joint dysfunction that is diagnosed by a doctor or dentist.
42 Decrease/reduce/relieve symptoms of soft tissue trauma Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
43 Decrease/reduce/relieve teething/tooth pain Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
44 Decrease/reduce/relieve tooth/teeth sensitivity Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
45 Decrease/reduce/relieve toothache Scientific or Traditional Label statement: If symptoms persist, talk to your health professional.
46 Decrease/reduce/relieve visual fatigue Scientific or Traditional Label statement: If symptoms
This is an opening excerpt, not the complete document.