Source: https://www.legislation.gov.au/Details/F2020L00106/Html/Text
Timestamp: 2020-04-08 02:37:15
Document Index: 91520646

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2']

Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020
Details: F2020L00106
- F2020L00106
This instrument specifies kinds of therapeutic goods information, relating to ingredients in relevant medicines and components of relevant biologicals, that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989.
F2020L00106
I, Jane Cook, as delegate of the Minister for Health, make the following specification.
5 Therapeutic goods information................................................................................................. 2
Schedule 1—Specified kinds of therapeutic goods information 4
Part 1—Medicines 4
Part 2—Biologicals 5
This instrument is the Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020.
(a) biological;
(b) included in the Register;
(c) medicine;
(d) Register; and
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:
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.
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.
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.
Schedule 1—Specified kinds of therapeutic goods information
Part 1—Medicines
Kinds of therapeutic goods information in relation to a relevant medicine
the name of each other ingredient
the presence of a proprietary colour
where the relevant medicine contains a proprietary colour—the word “colour”
the presence of a proprietary flavour
where the relevant medicine contains a proprietary flavour—the word “flavour”
the presence of a proprietary fragrance
where the relevant medicine contains a proprietary fragrance—the word “fragrance”
Part 2—Biologicals
Kinds of therapeutic goods information in relation to a relevant biological
the name and amount of each active component
the name of each other component
where the relevant biological contains a proprietary colour—the word “colour”
where the relevant biological contains a proprietary flavour—the word “flavour”
where the relevant biological contains a proprietary fragrance—the word “fragrance”