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This instrument is the Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.
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This instrument requires anyone applying under section 32DD to include a Class 2, 3 or 4 biological in the Australian Register of Therapeutic Goods to submit a dossier that meets the TGA’s July 2018 technical and general dossier requirements (ARGB v1.0 and General dossier requirements v1.4). It binds sponsors/manufacturers to a specific submission format, repeals an earlier 2018 determination, and makes applicants responsible for preparing the technical materials the TGA will use to assess inclusion.
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Direct links to the current provisions in Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.
This instrument is the Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.
This instrument commences on the day after it is registered.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
In this instrument:
Act means the Therapeutic Goods Act 1989.
Class 2 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 3 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 4 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to an application under section 32DD of the Act to include a Class 2 biological, Class 3 biological or Class 4 biological in the Australian Register of Therapeutic Goods.
For the purposes of subsection 32DDA(9) of the Act, an application relating to a Class 2,3 or 4 biological must be accompanied by the information required by the Technical Requirements section of the document titled Dossier requirements for Class 2, 3 and 4 biologicals, Australian Regulatory Guidelines for Biologicals (ARGB) version 1.0, published by the TGA in July 2018.
Note: The document mentioned in section 6 is available on the TGA website (www.tga.gov.au).
For the purposes of subsection 32DDA (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 7(b) is available on the TGA website (www.tga.gov.au).
Schedule 1—Repeals
Therapeutic Goods (Biologicals–Information that Must Accompany Application for Inclusion in Register) Determination 2018
1 The whole of the instrument
Repeal the instrument.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.
This instrument commences on the day after it is registered.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
In this instrument:
Act means the Therapeutic Goods Act 1989.
Class 2 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 3 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 4 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
This instrument applies to an application under section 32DD of the Act to include a Class 2 biological, Class 3 biological or Class 4 biological in the Australian Register of Therapeutic Goods.
For the purposes of subsection 32DDA(9) of the Act, an application relating to a Class 2,3 or 4 biological must be accompanied by the information required by the Technical Requirements section of the document titled Dossier requirements for Class 2, 3 and 4 biologicals, Australian Regulatory Guidelines for Biologicals (ARGB) version 1.0, published by the TGA in July 2018.
Note: The document mentioned in section 6 is available on the TGA website (www.tga.gov.au).
For the purposes of subsection 32DDA (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 7(b) is available on the TGA website (www.tga.gov.au).
Schedule 1—Repeals
Therapeutic Goods (Biologicals–Information that Must Accompany Application for Inclusion in Register) Determination 2018
1 The whole of the instrument
Repeal the instrument.