I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 26 July 2021
Nicole McLay
Assistant Secretary
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Restricted Representations - Oral Iron and Folic Acid Supplements) Permission 2021.
2 Commencement
- 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.
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. | 27 July 2021 |
Note: This table relates only to the provisions of this instrument as originally made.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.
- 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 42DK 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:
(a) directions for use;
(b) indication;
(c) label;
(d) medicine;
(e) Register;
(f) therapeutic good;
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Therapeutic Goods Regulations 1990.
capsule has the same meaning as in TGO 101.
prominently displayed or communicated has the same meaning as in the Therapeutic Goods Advertising Code.
registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.
restricted representation means a representation referred to in section 42DD of the Act.
specified goods means a registered medicine, other than a prescription medicine, that:
- (a) contains elemental iron and folic acid as the only active ingredients; and
- (b) is manufactured in the dosage form of a capsule or tablet for oral administration; and
- (c) has directions for use included on the label that contain dosing instructions only in relation to adults or children aged 12 years and older.
tablet has the same meaning as in TGO 101.
TGO 101 means the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
Note: TGO 101 may be accessed on the internet at www.legislation.gov.au.
5 Permission
For subsection 42DK(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the restricted representations specified in column 2 are permitted to be used in the advertisements specified in column 3, about the therapeutic goods specified in column 4, subject to the conditions (if any) specified in column 5.
Schedule 1 - Permission: restricted representation
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representation | Advertisement | Therapeutic goods | Conditions |
| 1 | a representation that is to the effect that the therapeutic goods are a source of iron and folic acid for the treatment or prevention of iron and folate (or folic acid) deficiency anaemia | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is: (a) on the label of the therapeutic goods; | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of iron and folate (or folic acid) deficiency anaemia | an advertisement about the therapeutic goods that is not: (a) on the label of the therapeutic goods; or must include a statement, which is prominently displayed or communicated and to the effect of the following: (d) for use when iron and folate (or folic acid) deficiency anaemia has been diagnosed by a doctor and a therapeutic oral iron and folic acid supplement is recommended for treatment or ongoing prevention. |
| 2 | a representation that is to the effect of one or more of the following: (a) the therapeutic goods are a source of iron and folic acid for the treatment or prevention of medically diagnosed iron and folate (or folic acid) deficiency anaemia; | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is: (a) on the label of the therapeutic goods; | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of iron and folate (or folic acid) deficiency anaemia | |
| 3 | a representation that is to the effect that the therapeutic goods are for the treatment and prevention of megaloblastic anaemia associated with folate (or folic acid) deficiency | an advertisement about the therapeutic goods that is: (a) on the label of the therapeutic goods; or | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of megaloblastic anaemia associated with folate (or folic acid) deficiency | |
| 4 | a representation that is to the effect that the therapeutic goods may help relieve fatigue associated with iron deficiency or iron deficiency anaemia | an advertisement about the therapeutic goods, including, but not limited to, an advertisement that is: (a) on the label of the therapeutic goods; | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of iron deficiency or iron deficiency anaemia, and relief of associated fatigue | an advertisement about therapeutic goods that is not: (a) on the label of the therapeutic goods; or must include a statement, which is prominently displayed or communicated and to the effect of the following: (d) for use when iron deficiency or iron deficiency anaemia has been diagnosed by a doctor and a therapeutic iron supplement is recommended for treatment or ongoing prevention |
| 5 | a representation that is to the effect that the therapeutic goods are for the treatment or prevention of medically diagnosed iron deficiency or iron deficiency anaemia | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is: (a) on the label of the therapeutic goods; | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of iron deficiency or iron deficiency anaemia | |
| 6 | a representation that is to the effect that the therapeutic goods are for the treatment or prevention of iron deficiency or iron deficiency anaemia | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is: (a) on the label of the therapeutic goods; | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the treatment or prevention of iron deficiency or iron deficiency anaemia | an advertisement about the therapeutic goods that is not: (a) on the label of the therapeutic goods; or must include a statement, which is prominently displayed or communicated and to the effect of the following: (d) for use when iron deficiency or iron deficiency anaemia has been diagnosed by your doctor and a therapeutic iron supplement is recommended for treatment or ongoing prevention |