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Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017
Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 10(1) of the Therapeutic Goods Act 1989, make the following order.

Dated 26 September 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

     1 Name of order
         This order is the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.
     2 Commencement
         (1) Each provision of this order 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 order  30 September 2017

              Note: This table relates only to the provisions of this order as originally made. It will not be amended to deal with any later amendments of this order.
         (2) Any information in column 3 of the table is not part of this order. Information may be inserted in this column, or information in it may be edited, in any published version of this order.
     3 Authority
          This order is made under subsection 10(1) of the Therapeutic Goods Act 1989.
     4 Interpretation
          In this order:

         Act means the Therapeutic Goods Act 1989.

         cord blood means the blood remaining in the human placenta and umbilical cord after the umbilical cord has been clamped.

         NetCord-FACT International Standards means the document titled NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Sixth Edition, published by NetCord and the Foundation for the Accreditation of Cellular Therapy in July 2016, as in force at that time.

         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.

              Note 1 A number of expressions used in this order are defined in the Act, including the following:

                  (a)            manufacture;

                  (b)           Register;

                  (c)            standard; and

                  (d)           therapeutic goods.

              Note 2 NetCord-FACT International Standards are available for free download from the Foundation for the Accreditation of Cellular Therapy website: www.factweb.org/forms/store/ProductFormPublic/sixth-edition-netcord-fact-international-standards-for-cord-blood-collection-banking-and-release-for-administration-free-download.
     5 Repeal
         This order repeals the instrument specified in Schedule 1.
     6 Application
         (1) Subject to subsection (2), this order applies to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
         (2) This order does not apply to therapeutic goods that are haematopoietic progenitor cells derived from:
              (a) bone marrow;
              (b) peripheral blood;
              (c) cord blood that is processed beyond minimal manipulation; and
              (d) any tissue other than cord blood.
     7 Standard
         (1) The matters specified in