Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021

I, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following order.

Dated 24 September 2021

Adjunct Professor John Skerritt

Contents

Part 1Preliminary

1  Name

2  Commencement

3  Authority

4  Definitions

5  Standard

6  Application

7  Transitional arrangements

Part 2Labelling requirements

8  General requirements

9  Labels of HCT materials

10  Labels of biologicals

Schedule 1—Labels in relation to HCT materials

Schedule 2—Labels in relation to biologicals

Part 1—Information on or attached to containers and primary packs

Part 2—Information on, attached to, or supplied with containers or primary packs

Part 1Preliminary

1  Name

 (1) This instrument is the Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021.

 (2) This instrument may also be cited as TGO 107.

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.

Note: This table relates only to the provisions of this instrument as originally made.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 section 10 of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) batch;

(b) bioburden;

(c) biological;

(d) container;

(e) label;

(f) manufacture;

(g) primary pack;

(h) Register;

(i) standard.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

allogeneic use, in relation to a biological that comprises, contains or is derived from HCT materials, means administration to, or application in the treatment of, a person other than the person from whom the HCT materials used in the manufacture of the biological were collected.

autologous use, in relation to a biological that comprises, contains or is derived from HCT materials, means administration to, or application in the treatment of, the person from whom the HCT materials used in the manufacture of the biological were collected.

Class 1 biological has the same meaning as in the Regulations.

Class 2 biological has the same meaning as in the Regulations.

Class 3 biological has the same meaning as in the Regulations.

Class 4 biological has the same meaning as in the Regulations.

directed allogeneic use, in relation to a biological that comprises, contains or is derived from HCT materials, means allogeneic use for which all of the following paragraphs apply:

 (a) the HCT materials used in the manufacture of the biological are collected by, or under the professional supervision or direction of, a medical or dental practitioner; and

 (b) the biological is manufactured for administration to, or application in the treatment of, a designated patient who has a pre-existing condition by, or under the professional supervision or direction of, a medical or dental practitioner; and

 (c) the medical or dental practitioners mentioned in paragraphs (a) and (b) are registered in a State or internal Territory.

expiry date has the same meaning as in the Regulations.

HCT materials means one or more of the following materials:

 (a) human cells;

 (b) human tissues;

 (c) human stool;

that are collected for use in the manufacture of a biological and are:

 (d) materials intended to comprise, or be contained in, the biological; or

 (e) materials from which the biological is intended to be derived.

Regulations means the Therapeutic Goods Regulations 1990.

5  Standard

  The matters specified in this instrument constitute a standard for biologicals in relation to labelling.

6  Application

 (1) This instrument applies in relation to biologicals supplied in Australia, other than biologicals that are mentioned in item 13 of Schedule 5A to the Regulations, subject to compliance with the condition specified in that item.

 (2) This instrument does not apply in relation to biologicals exported from Australia, other than the requirements specified in subsections 9(3) and 10(2).

7  Transitional arrangements

 (1) In this section:

  former instrument means the Therapeutic Goods Order No. 87 General requirements for the labelling of biologicals, as in force immediately before the commencement of the repeal instrument.

  repeal instrument means the Therapeutic Goods (Standards for Biologicals) Repeal Instrument 2021.

  transition period means the period beginning on 30 September 2021 and ending on 30 September 2022.

 (2) Despite the repeal of the former instrument by the repeal instrument, the former instrument continues to apply for the duration of the transition period, such that the standard for biologicals in relation to labelling constituted by the former instrument may be conformed with as an alternative to the standard for biologicals in relation to labelling constituted by this instrument.

Part 2Labelling requirements

8  General requirements

 (1) The information that is displayed on a label of a biological or HCT materials must be:

 (a) in English; and

 (b) clearly visible and not obscured; and

 (c) in legible and durable characters, with a letter height of not less than 1.5 millimetres; and

 (d) in metric units of measurement.

 (2) The label of a biological or HCT materials must:

 (a) be securely attached to the container and primary pack in which the biological or HCT materials are supplied; and

 (b) maintain integrity and remain attached to the container and primary pack at the relevant storage conditions for the biological and HCT materials.

 (3) The container of a biological or HCT materials must be labelled to ensure traceability to the donor of the HCT materials at each step of manufacture.

 (4) To avoid doubt, the requirements set out in this instrument do not apply in relation to transparent coverings, where those coverings enclose or wrap:

 (a) a container containing HCT materials; or

 (b) a container or primary pack containing a biological; and

the information required to be on or attached to the container or primary pack is clearly visible and not obscured by the covering.

9  Labels of HCT materials

 (1) Subject to subsections (2) and (3), HCT materials must be labelled in accordance with the following:

 (a) all information specified in the table in Schedule 1:

 (i) must be on or attached to the container of the HCT materials; or

 (ii) where the HCT materials are packaged in a sterile container—may instead be on or attached to the first external non-sterile layer of packaging of the HCT materials.

 (2) If there is not sufficient space on the container of the HCT materials to include all information specified in the table in Schedule 1, then:

 (a) the information specified in item 1 of the table in Schedule 1 must be on or attached to the container; and

 (b) the information specified in items 2 to 5 of the table in Schedule 1 must be supplied with the container.

 (3) HCT materials exported from Australia must be labelled with information specified in item 1 of Schedule 1, that is on or attached:

 (a) to the container of the HCT materials; or

 (b) where the HCT materials are packaged in a sterile container—to the first external non-sterile layer of packaging of the HCT materials.

10  Labels of biologicals

 (1) Subject to subsection (2), a biological must be labelled in accordance with the following:

 (a) all Part 1 information:

 (i) must be on or attached to the container and the primary pack of the biological; or

 (ii) where the biological is packaged in a sterile container— may instead be on or attached to the first external non-sterile layer of packaging and the primary pack of the biological; and

 (b) all Part 2 information must be:

 (i) on or attached to the container or the primary pack of the biological; or

 (ii) supplied with the container or the primary pack of the biological, including where the information is contained in an electronic reference document, with a link or QR code to the document on or attached to the container or the primary pack of the biological.

 (2) A biological exported from Australia must be labelled with information specified in item 1 of Part 1 of Schedule 2, that is on or attached:

 (a) to the container or the primary pack of the biological; or

 (b) where the biological is packaged in a sterile container—to the first external non-sterile layer of packaging and the primary pack of the biological.

 (3) In this section:

Part 1 information, in relation to a biological, means the information specified in an item of the table in Part 1 of Schedule 2 if:

 (a) the expression “in all cases” is mentioned in column 3 of that item; or

 (b) the circumstances mentioned in column 3 of that item exist in relation to the biological.

Part 2 information, in relation to a biological, means the information specified in an item of the table in Part 2 of Schedule 2 if:

 (a) the expression “in all cases” is mentioned in column 3 of that item; or

 (b) the circumstances mentioned in column 3 of that item exist in relation to the biological.

Schedule 1—Labels in relation to HCT materials

Note: See section 9.

Schedule 2—Labels in relation to biologicals

Note: See section 10.

Part 1—Information on or attached to containers and primary packs

Part 2—Information on, attached to, or supplied with containers or primary packs