Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020

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

Dated 7 February 2020

Dr Jane Cook

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Therapeutic goods information

Schedule 1—Specified kinds of therapeutic goods information

Part 1—Medicines

Part 2—Biologicals

1  Name

  This instrument is the Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020.

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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5D) 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)      biological;

(b)      included in the Register;

(c) medicine;

(d) Register; and

(e) therapeutic goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

active component, in relation to a biological, means a therapeutically active component in the final formulation of the biological that is responsible for its physiological action.

active ingredient has the same meaning as in the Regulations.

other component, in relation to a relevant biological, means a component of the biological other than:

(a) an active component;

(b) a proprietary colour;

(c) a proprietary flavour; or

(d) a proprietary fragrance.

other ingredient, in relation to a relevant medicine, means an ingredient in the medicine other than:

(a) an active ingredient;

(b) a proprietary colour;

(c) a proprietary flavour; or

(d) a proprietary fragrance.

proprietary colour means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing colour to a therapeutic good, or part of a therapeutic good.

proprietary flavour means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing flavour to a therapeutic good, or part of a therapeutic good.

proprietary fragrance means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing fragrance to a therapeutic good, or part of a therapeutic good.

Regulations means the Therapeutic Goods Regulations 1990.

relevant biological means a biological included in the Register.

relevant medicine means a medicine included in:

(a) the part of the Register for goods known as registered goods; or

(b) the part of the Register for goods known as listed goods.

TGA Business Services means TGA Business Services on the Therapeutic Goods Administration website that may be accessed on the internet at https://business.tga.gov.au.

Therapeutic Goods Administration has the same meaning as in the Regulations.

therapeutic goods information has the meaning given by subsection 61(1) of the Act.

5  Therapeutic goods information

 (1) In relation to a relevant medicine, the kinds of therapeutic goods information mentioned in column 2 of the table in Part 1 of Schedule 1, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.

 (2) In relation to a relevant biological, the kinds of therapeutic goods information mentioned in column 2 of the table in Part 2 of Schedule 1, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.

Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).

Schedule 1—Specified kinds of therapeutic goods information

Note: See section 5.

Part 1—Medicines

Part 2—Biologicals