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This instrument is the Therapeutic Goods (OTC 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This Act has been repealed and is no longer in force. It is retained for historical reference.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 rule sets the paperwork and filing format companies must use to register over‑the‑counter (OTC) medicines in Australia. It affects pharmaceutical firms, manufacturers and importers seeking TGA approval and requires inclusion of the information in the TGA’s Common Technical Document Module 1 and the Mandatory requirements, compiled into an application dossier per the General dossier requirements. The standardisation helps the TGA consistently assess safety, quality and suitability for Australian consumers.
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Direct links to the current provisions in Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination 2018.
This instrument is the Therapeutic Goods (OTC 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.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to medicines of the kind specified in paragraph 4(1)(c) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.
For the purposes of subsection 23B(9) of the Act, the application must be accompanied by: (a) the information specified in the document titled Common Technical Document Module 1: OTC Medicines, version 1.2, published by the TGA in June 2017; and (b) the information required by the document titled Mandatory requirements for an effective over-the-counter medicines application, version 1.1, published by the TGA in March 2016.
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 (OTC 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.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to medicines of the kind specified in paragraph 4(1)(c) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.
For the purposes of subsection 23B(9) of the Act, the application must be accompanied by: (a) the information specified in the document titled Common Technical Document Module 1: OTC Medicines, version 1.2, published by the TGA in June 2017; and (b) the information required by the document titled Mandatory requirements for an effective over-the-counter medicines application, version 1.1, published by the TGA in March 2016.
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).