Federal Register of Legislation
Therapeutic Goods (Biologicals—Specified Things) Instrument 2021
I, John Skerritt, as delegate of the Secretary of the Department of Health, make the following instrument.
Dated 24 September 2021
Adjunct Professor John Skerritt Deputy Secretary Health Products Regulation Group Department of Health
Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Specified things—biologicals 6 Specified things—not biologicals 7 Repeals Schedule 1—Specified things: biologicals Schedule 2—Specified things: not biologicals Schedule 3—Repeals Therapeutic Goods (Things that are Biologicals) Specification 2019 Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011
1 Name This instrument is the Therapeutic Goods (Biologicals—Specified Things) Instrument 2021.
2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 30 September 2021. 30 September 2021
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority This instrument is made under section 32A of the Therapeutic Goods Act 1989.
4 Definitions Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) biological. In this instrument: Act means the Therapeutic Goods Act 1989. biological medicine has the same meaning as in the Regulations. faecal microbiota transplant product has the same meaning as in the Regulations. in-house IVD medical device has the same meaning as in the Medical Devices Regulations. IVD medical device has the same meaning as in the Medical Devices Regulations. Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002. Regulations means the Therapeutic Goods Regulations 1990.
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