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

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 2 Commencement 3 Authority 4 Definitions 5 Standard 6 Application 7 Requirements 8 Transitional arrangements 9 Repeals 10 Consequential amendments Schedule 1—Repeals Therapeutic Goods Order No 81 Standards for Blood and Blood Components Schedule 2—Consequential amendments Therapeutic Goods (Manufacturing Principles) Determination 2018

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Note: This table relates only to the provisions of this instrument as originally made.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