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TGO 102 Orders/Other as made
This order establishes a ministerial standard for therapeutic goods that are blood and blood components, replaces the existing Therapeutic Goods Order No. 81 Standards for Blood and Blood Components due to sunset on 1 April 2019, and makes a minor consequential amendment to the Therapeutic Goods (Manufacturing Principles) Determination 2018.
Administered by: Health
Registered 25 Mar 2019
Tabling HistoryDate
Tabled HR02-Apr-2019
Tabled Senate02-Apr-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019

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

Dated 22 March 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  Definitions................................................................................................................................ 1

5  Standard................................................................................................................................... 2

6  Application............................................................................................................................... 2

7  Requirements............................................................................................................................ 2

8  Transitional arrangements......................................................................................................... 3

9  Repeals..................................................................................................................................... 3

10  Consequential amendments.................................................................................................... 3

Schedule 1—Repeals                                                                                                     4

Therapeutic Goods Order No 81 Standards for Blood and Blood Components                       4

Schedule 2—Consequential amendments                                                                   5

Therapeutic Goods (Manufacturing Principles) Determination 2018                                          5

 


1  Name

             (1)       This instrument is the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.

             (2)       This instrument may also be cited as TGO 102.

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

31 March 2019.

31 March 2019

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 sections 10 and 36 of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a)    manufacture; and

(b)    therapeutic goods.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.

blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:

                     (a)  red cells;

                     (b)  white cells;

                     (c)  platelets;

                     (d)  plasma;

but does not include haematopoietic progenitor cells.

Guide means the Guide to the preparation, use and quality assurance of blood components, 19th edition, 2017, published by the Council of Europe, as in force or existing immediately before the commencement of this instrument.

Note:          The Guide is published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe at: www.edqm.eu.

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.

HBV means hepatitis B virus.

HCV means hepatitis C virus.

HIV-1 means human immunodeficiency virus.

5  Standard

                   This instrument constitutes a standard for blood and blood components.

Application

             (1)  Subject to subsection (2), this instrument applies to therapeutic goods that are blood and blood components.

             (2)  This instrument does not apply to therapeutic goods that are:

                     (a)  collected by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, in the course of medical treatment and for the purposes of diagnosis of, and testing for, a medical condition;

                     (b)  manufactured by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, for therapeutic application to a patient under the practitioner’s care; or

                     (c)  manufactured by a blood donation centre for a medical practitioner, registered under a law of a State or Territory, for therapeutic application to a particular patient under the practitioner’s care.

7  Requirements

             (1)  The requirements in relation to blood and blood components are:

                     (a)  subject to subsection (2), those requirements specified in the Guide; and

                     (b)  those requirements specified in subsections (3) and (4).

             (2)  The reference to ‘tropical areas’ in relation to the deferral period for the condition Tropical infections in Table 2.2. Conditions leading to temporary deferral (suspension) on page 253 of the Guide is to be taken not to include areas within Australia.

Note:              For the definition of Guide, see section 4.

             (3)  Blood and blood components must only be manufactured from blood where samples of that blood test negative for HBV, HCV and HIV-1, using

nucleic acid amplification technology.

             (4)  Blood and blood components must not be manufactured from a donor:

                     (a)  who lived in, or visited, England, Scotland, Wales, Northern Ireland or the Isle of Man for a cumulative period of 6 months or more, at any time on or between 1 January 1980 and 31 December 1996; or

                     (b)  who received a transfusion or injection of blood or blood products while in England, Scotland, Wales, Northern Island or the Isle of Man, at any time on or after 1 January 1980.

8  Transitional arrangements

             (1)  In this section:

                   former instrument means the Therapeutic Goods Order No. 81 – Standards for Blood and Blood Components, as in force immediately before the commencement of this instrument.

                   transition period means the period beginning on 31 March 2019 and ending on 30 March 2020.

             (2)  Despite the repeal of the former instrument by section 9 of this instrument, the former instrument continues to apply for the duration of the transition period, such that the standard for blood and blood components constituted by the former instrument may be conformed with as an alternative to the standard for blood and blood components constituted by this instrument.

9  Repeals

                   Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in the applicable items in that Schedule.

10  Consequential amendments

                   Each instrument that is specified in Schedule 2 to this instrument is amended as set out in the applicable items in that Schedule.


 

Schedule 1—Repeals

Note:       See section 9.

Therapeutic Goods Order No 81 Standards for Blood and Blood Components

1  The whole of the instrument

Repeal the instrument.


 

Schedule 2Consequential amendments

Note:       See section 10.

Therapeutic Goods (Manufacturing Principles) Determination 2018

1  Section 4 (paragraph b of the definition of Technical Master File)

Omit “Therapeutic Goods Order No.81 – Standards for Blood and Blood Components”, substitute “Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019”.