Contents
1 Name#
This instrument is the Therapeutic Goods (Information Specification—Manufacturing Inspections) 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Note: This table relates only to the provisions of this instrument as originally made.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) licence;
(b) manufacture;
(c) manufacturing principles;
(d) manufacturing site;
(e) medical device;
(f) medicine;
(g) Secretary;
(h) therapeutic goods.
In this instrument:
active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.
Note: An active pharmaceutical ingredient is intended to furnish a pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.
GMP certificate means a certificate issued by the TGA in relation to a manufacturer of therapeutic goods (other than medical devices), following an inspection of the manufacturer, which certifies that the manufacturer complies with the applicable guide to, or code of, good manufacturing practice.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.
TGA means the part of the Department known as the Therapeutic Goods Administration.
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).
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 inspection of a manufacturer of therapeutic goods (other than medical devices) that occurs in or outside Australia, including, but not limited to, the following: |
| 2 | information in a GMP certificate, including, but not limited to, the following: |
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.