Contents
1 Name#
This instrument is the Therapeutic Goods (Information Specification—Annual Charge Exemption Scheme) Instrument 2026.
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 |
| 1. The whole of this instrument | The day after this instrument is registered. |
Note: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5D) 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) biological number;
(b) device number;
(c) included in the Register;
(d) listing number;
(e) Register;
(f) registration number;
(g) Secretary;
(h) therapeutic goods.
In this instrument:
Annual Charge Exemption Scheme means the scheme relating to exemptions from liability to pay annual charges set out in Subdivision 2 of Division 1 of Part 7 of the Regulations.
Regulations means the Therapeutic Goods Regulations 1990.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.
5 Release of therapeutic goods information#
For the purpose of subsection 61(5C) of the Act, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1 may be released to the public.
Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).
6 Repeals#
Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.
Schedule 1—Release of therapeutic goods information to the public
Note: See section 5.
| Therapeutic goods information that may be released to the public | |
|---|---|
| Column 1 | Column 2 |
| Item | Kinds of therapeutic goods information |
| 1 | information relating to an exemption under the Annual Charge Exemption Scheme in respect of a person in relation to whom therapeutic goods were registered, listed or included in the Register in a particular financial year, including the following:(a) the name of the person;(b) the name of the goods;(c) the registration number, listing number, biological number or device number of the goods;(d) the details of the exemption, such as the financial year to which the exemption relates;(e) information relating to the declaration of turnover under regulation 43AAC or 43AAD of the Regulations |
| 2 | information relating to a notice under regulation 43AAG of the Regulations that the person in relation to whom therapeutic goods were registered, listed or included in the Register in a particular financial year was not exempt under the Annual Charge Exemption Scheme, including the following:(a) the name of the person;(b) the name of the goods;(c) the registration number, listing number, biological number or device number of the goods;(d) the details of the notice, such as the financial year in which the person is not exempt under the Annual Charge Exemption Scheme;(e) information relating to the declaration of turnover under regulation 43AAC or 43AAD of the Regulations |
Note: See section 6.
Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016#
1 The whole of the instrument
Repeal the instrument.
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.