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I, Gillian Mitchell, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 27 July 2021
Gillian Mitchell
First Assistant Secretary
Regulatory Practice and Support Division
Health Products Regulation Group
Department of Health
Contents
Schedule 1 - Permission: restricted representations
Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission (No. 2) 2021
1 Name
This instrument is the Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission (No. 3) 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. | 28 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Note: This table relates only to the provisions of this instrument as originally made.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) advertise;
(b) current Poisons Standard;
(c) health practitioner;
(d) Register;
(e) registered goods;
(f) supply;
(g) therapeutic goods.
In this instrument:
Act means Therapeutic Goods Act 1989.
active ingredients has the same meaning as in the Regulations.
approved COVID-19 vaccination provider means a provider who is:
- a recognised vaccination provider within the meaning of the Australian Immunisation Register Act 2015; and
- approved or authorised under relevant state or territory legislation to administer relevant COVID-19 vaccines; and
- approved by the Department to participate in the National COVID-19 Vaccination Program.
Regulations means the Therapeutic Goods Regulations 1990.
relevant COVID-19 vaccines means registered goods containing a substance included in Schedule 4 to the current Poisons Standard for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the active immunisation for the prevention of the coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
Note: The expression registered goods is defined in section 3 of the Act to mean:
(a) therapeutic goods included in the part of the Register for goods known as registered goods; or
(b) therapeutic goods included in the part of the Register for goods known as provisionally registered goods.
restricted representation means a representation referred to in section 42DD of the Act.
trade name has the same meaning as in the Regulations.
valuable consideration means any consideration of value but does not include tobacco or medicines (other than listed medicines).
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.
- To avoid doubt, an advertisement made in accordance with this instrument that references, expressly or by implication, that the therapeutic goods to which this instrument relates have been recommended or approved by the Therapeutic Goods Administration (within the Australian Government Department of Health), the Australian Government Department of Health or the Commonwealth Government is, by virtue of this instrument, also authorised for the purposes of subsections 42DL(9), 42DL(10), 42DLB(6) and 42DLB(7) of the Act.
- The permission given in subsection (1) applies for the period starting on the commencement of this instrument and ending on 31 December 2022.
Application
This instrument does not apply to an advertisement made in accordance with the Therapeutic Goods (Restricted Representations - Government Health Campaigns) Permission 2019.
Note 1: The Therapeutic Goods (Restricted Representations - Government Health Campaigns) Permission 2019 deals with Commonwealth and state or territory health campaigns relating to vaccines.
The Therapeutic Goods (Restricted Representations - Government Health Campaigns) Permission 2019 is published at www.tga.gov.au
Repeals
Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Permission: restricted representations
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representation | Advertisement | Therapeutic goods | Conditions |
| 1 | a representation relating to the therapeutic goods that promotes the use or supply of those goods | an advertisement about the therapeutic goods, other than an advertisement that is:
| relevant COVID-19 vaccines | the advertisement must:
|
| 2 | a representation to the effect that valuable consideration may be provided to a person who has been fully vaccinated with the therapeutic goods in accordance with the National COVID-19 Vaccination Program, where the offer of valuable consideration is not conditional on vaccination occurring after that offer is made | an advertisement about the therapeutic goods made in accordance with item 1 | relevant COVID-19 vaccines | the advertisement must:
|
Schedule 2 - Repeals
Note: See section 7.
Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission (No. 2) 2021
1 The whole of the instrument
Repeal the instrument.