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This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018.
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This instrument requires applications to list a complementary medicine under section 26AE to include two specified TGA documents (CTD Module 1 and Mandatory requirements for assessed listed medicines) and to submit them as a dossier formatted to the TGA's General dossier requirements v1.4. It affects sponsors/manufacturers who apply to list complementary medicines: they must prepare and format prescribed materials for TGA assessment (see sections 4–6). The change standardises submission content and form, imposing a compliance task on applicants.
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Direct links to the current provisions in Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018.
This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 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 list a complementary medicine under section 26AE of the Act.
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: Administrative information for assessed listed medicines, version 1, published by the TGA in March 2018; and (b) the information required by the document titled Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, 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 1.4, published by the TGA in July 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 Section 26AE Listing) Determination August 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 list a complementary medicine under section 26AE of the Act.
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: Administrative information for assessed listed medicines, version 1, published by the TGA in March 2018; and (b) the information required by the document titled Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, 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 1.4, published by the TGA in July 2018.
Note: The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).