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This instrument is the Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018.
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This Determination attaches conditions to biologicals on the Register: sponsors must keep distribution records for at least 10 years and follow the TGA’s "Biovigilance Responsibilities of Sponsors of Biologicals" (Dec 2017) (s4). They also may not implement any variation to a biological before the Secretary approves a Register variation under section 9D of the Act (s5); sponsors therefore incur reporting and approval burdens and the Secretary holds approval discretion.
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Direct links to the current provisions in Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018.
This instrument is the Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018.
This instrument commences on the day after it is registered.
In this instrument:
Act means the Therapeutic Goods Act 1989.
For the purposes of paragraphs 32EC(2)(c) and (ca) of the Act, a person in relation to whom a biological is included in the Register must: (a) in relation to each distribution of the biologicals—keep a record of the distribution at least until the end of the period of 10 years after the distribution; and (b) comply with the record-keeping requirements and the reporting requirements set out in the document titled Biovigilance Responsibilities of Sponsors of Biologicals – Australian requirements and recommendations, version 1.0, published by the Therapeutic Goods Administration in December 2017.
Note: A copy of the document mentioned in paragraph 4(b) is available on the Therapeutic Goods Administration website (www.tga.gov.au).
For the purposes of paragraph 32EC(2)(e), a person in relation to whom a biological is included in the Register must not implement a variation to, or in relation to, the biological before the Secretary approves the variation by varying the entry in the Register that relates to the biological under section 9D of the Act.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018.
This instrument commences on the day after it is registered.
In this instrument:
Act means the Therapeutic Goods Act 1989.
For the purposes of paragraphs 32EC(2)(c) and (ca) of the Act, a person in relation to whom a biological is included in the Register must: (a) in relation to each distribution of the biologicals—keep a record of the distribution at least until the end of the period of 10 years after the distribution; and (b) comply with the record-keeping requirements and the reporting requirements set out in the document titled Biovigilance Responsibilities of Sponsors of Biologicals – Australian requirements and recommendations, version 1.0, published by the Therapeutic Goods Administration in December 2017.
Note: A copy of the document mentioned in paragraph 4(b) is available on the Therapeutic Goods Administration website (www.tga.gov.au).
For the purposes of paragraph 32EC(2)(e), a person in relation to whom a biological is included in the Register must not implement a variation to, or in relation to, the biological before the Secretary approves the variation by varying the entry in the Register that relates to the biological under section 9D of the Act.