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This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This determination sets out the paperwork requirements for companies applying to register complementary medicines (such as vitamins, herbal remedies, and traditional medicines) with Australia's Therapeutic Goods Administration (TGA).
What it requires:
Who it affects:
Why it matters: The determination ensures every application contains the same essential safety and quality information, formatted consistently. This allows the TGA to efficiently assess whether a medicine meets the standards for registration.
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Direct links to the current provisions in Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.
This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.
This instrument commences on the day after it is registered.
In this instrument:
Act means the Therapeutic Goods Act 1989.
complementary medicine means a medicine of the kind specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to an application to register a complementary medicine.
For the purposes of subsection 23B(9) of the Act, the application must be accompanied by: (a) the information required by the document titled CTD Module 1: registered complementary medicines, version 8.0, published by the TGA in April 2018; and (b) the information required by the document titled Mandatory requirements for an effective registered complementary medicines application, version 1, published by the TGA in March 2018.
Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).
For the purposes of subsection 23B(10) of the Act, the information must be : (a) contained in an application dossier; and (b) in a form consistent with the document titled General dossier requirements, version 1.3, published by the TGA in March 2018.
Note: The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.
This instrument commences on the day after it is registered.
In this instrument:
Act means the Therapeutic Goods Act 1989.
complementary medicine means a medicine of the kind specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to an application to register a complementary medicine.
For the purposes of subsection 23B(9) of the Act, the application must be accompanied by: (a) the information required by the document titled CTD Module 1: registered complementary medicines, version 8.0, published by the TGA in April 2018; and (b) the information required by the document titled Mandatory requirements for an effective registered complementary medicines application, version 1, published by the TGA in March 2018.
Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).
For the purposes of subsection 23B(10) of the Act, the information must be : (a) contained in an application dossier; and (b) in a form consistent with the document titled General dossier requirements, version 1.3, published by the TGA in March 2018.
Note: The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).