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This instrument is the Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018.
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This Determination tells applicants what information and file format must accompany registration applications for certain over‑the‑counter (OTC) medicines under the Therapeutic Goods Act. It applies to the medicines listed in paragraph 4(1)(c) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.
Applicants must supply the content set out in the TGA's Common Technical Document Module 1: OTC Medicines (v1.2) and the Mandatory requirements for an effective over‑the‑counter medicines application (v1.1), and lodge them as an application dossier consistent with the TGA's General dossier requirements (v1.4). This creates a documentation and formatting compliance obligation for applicants.
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Direct links to the current provisions in Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018.
This instrument is the Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 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 1.4, 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 (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 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 1.4, 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).