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Determinations/Health as made
This instrument repeals the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (the former determination) and amends the Therapeutic Goods (Excluded Goods) Determination 2018 to include the products specified as excluded goods by the former determination. It also makes a small number of minor amendments, principally to the circumstances in which human cells and tissues that are excluded by the former determination may be manufactured in order to qualify for the exclusion.
Administered by: Health
Registered 21 Jun 2019
Tabling HistoryDate
Tabled HR02-Jul-2019
Tabled Senate02-Jul-2019
Date of repeal 17 Sep 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Amendment (Excluded Goods) Determination 2019

I, Jane Cook, as delegate of the Minister for Health, make the following determination.

Dated 20 June 2019

Jane Cook

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health

 


Contents

1  Name........................................................................................................................................ 1

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

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

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

Therapeutic Goods (Excluded Goods) Determination 2018                                                         2

Schedule 2—Repeals                                                                                                     4

Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018                          4

 

 


1  Name

                   This instrument is the Therapeutic Goods Amendment (Excluded Goods) Determination 2019.

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

The day after this instrument is registered.

 

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 7AA of the Therapeutic Goods Act 1989.

4  Schedules

                   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.

Schedule 1Amendments

Therapeutic Goods (Excluded Goods) Determination 2018

1  Section 3

Omit “Act”, substitute “Therapeutic Goods Act 1989”.

2  Section 4

Insert:

haematopoietic progenitor cells has the meaning given by clause 1 of Part 1 of Schedule 9 to the Regulations.

 

Regulations means the Therapeutic Goods Regulations 1990.

3  Schedule 2 (after table item 4)

Insert:

4A

goods in relation to which the following paragraphs apply:

(a)     the goods comprise, contain or are derived from, human cells or human tissues collected from a patient (the relevant patient) who is under the clinical care of a medical or dental practitioner (the relevant practitioner);

(b)     the relevant practitioner is registered in a State or internal Territory;

(c)     subject to paragraph (d), all steps in the manufacture of the goods are carried out by, or under the professional supervision of, the relevant practitioner in a hospital in a State or internal Territory (the relevant hospital);

(d)     if a step in the manufacture of the goods relating to the storage or testing of the goods is not carried out in the relevant hospital, it is carried out by a person under contract with the relevant hospital

when the goods are:

(a)    used for the relevant patient, who is a patient of the relevant hospital; and

(b)    not advertised directly to consumers

4B

goods that are fresh viable human haematopoietic progenitor cells

when used for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution

4C

goods that are fresh viable human organs or parts of human organs

when used for direct donor-to-host transplantation

4D

goods that are human reproductive tissue

when used in assisted reproductive therapy

4  Schedule 2 (note at the end)

Repeal the note.

Schedule 2Repeals

Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018

1  The whole of the instrument

Repeal the instrument.