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

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Note:          This table relates only to the provisions of this determination as originally made.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