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Specifications as made
This instrument specifies things that are (where those things also satisfy paragraph 32A(1)(b) of the Therapeutic Goods Act 1989), and things that are not, biologicals for section 32A of the Therapeutic Goods Act 1989. This instrument also repeals the Therapeutic Goods (Things that are Biologicals) Specification 2019 and the Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011.
Administered by: Health
Registered 28 Sep 2021
Tabling HistoryDate
Tabled HR18-Oct-2021
Tabled Senate18-Oct-2021
Table of contents.

Commonwealth Coat of Arms of Australia

 

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........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Specified things—biologicals................................................................................................... 2

6  Specified things—not biologicals............................................................................................. 2

7  Repeals..................................................................................................................................... 2

Schedule 1—Specified things: biologicals                                                                   3

Schedule 2—Specified things: not biologicals                                                             4

Schedule 3—Repeals                                                                                                     5

Therapeutic Goods (Things that are Biologicals) Specification 2019                                       5

Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011                  5

 

 


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.

5  Specified things—biologicals

                   For subsection 32A(2) of the Act, the things mentioned in Schedule 1 are specified for the purposes of subparagraph 32A(1)(a)(ii) of the Act.

Specified things—not biologicals

                   For subsection 32A(3) of the Act, the things specified in Schedule 2 are determined not to be biologicals for the purposes of the Act.

7  Repeals

                   Each instrument that is specified in Schedule 3 is repealed as set out in the applicable items in that Schedule.


 

Schedule 1—Specified things: biologicals

Note:       See section 5.

Specified things for the purposes of subparagraph 32A(1)(a)(ii) of the Act

Column 1

Column 2

Item

Specified things

1

a thing that comprises or contains live animal cells, tissues, or organs

2

a thing that is a faecal microbiota transplant product


 

Schedule 2—Specified things: not biologicals

Note:       See section 6.

Specified things that are not biologicals

Column 1

Column 2

Item

Specified things

1

biological medicines, other than vaccines that contain viable human cells

2

haematopoietic progenitor cells used for haematopoietic reconstitution

3

IVD medical devices and in-house IVD medical devices

4

samples of human cell or tissue of an individual that are solely for diagnostic purposes in that individual

Note:       Biological medicines include blood and blood components.


 

Schedule 3—Repeals

Note:       See section 7.

Therapeutic Goods (Things that are Biologicals) Specification 2019

1  The whole of the instrument

Repeal the instrument.

Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011

2  The whole of the instrument

Repeal the instrument.