Federal Register of Legislation - Australian Government

Primary content

Orders/Other as made
This instrument amends the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 on account of the repeal of a former standard, Therapeutic Goods Order No. 75 – Standard for Haematopoietic Progenitor Cells Derived from Cord Blood, and the making of a new standard, Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.
Administered by: Health
Registered 28 Sep 2017
Tabling HistoryDate
Tabled HR16-Oct-2017
Tabled Senate16-Oct-2017
Date of repeal 01 Oct 2017
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 36(1) of the Therapeutic Goods Act 1989, make the following determination.

Dated 26 September 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health


1            Name of determination

This determination is the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2).

2            Commencement

(1)     Each provision of this determination 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 determination

30 September 2017

 

Note:          This table relates only to the provisions of this determination as originally made. It will not be amended to deal with any later amendments of this determination.

(2)     Any information in column 3 of the table is not part of this determination. Information may be inserted in this column, or information in it may be edited, in any published version of this determination.

3            Authority

            This determination is made under subsection 36(1) of the Therapeutic Goods Act 1989.

4            Schedule

The Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 is amended as set out in Schedule 1.

 


Schedule 1        Amendments

(section 4)

 

[1]          Section 4 (definition of haematopoietic progenitor cells)

Omit the definition, substitute:

haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.

[2]          Section 4 (subparagraph (b)(ii) of the definition of Technical Master File)

Omit the subparagraph, substitute:

the haematopoietic progenitor cells derived from cord blood manufactured using the steps of manufacture mentioned in paragraph (a) will meet the standard set out in the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017; and