Therapeutic Goods Information (Laboratory
Testing) Specification 2017
Therapeutic Goods Act 1989
I, JOHN SKERRITT, a delegate of the Minister for Health, make this specification under
subsection 61(5D) of the Therapeutic Goods Act 1989.
Dated 5 April 2017
(Signed by)
JOHN SKERRITT
Delegate of the Minister for Health
Section 1
1
Name of specification
This specification is the Therapeutic Goods Information (Laboratory
Testing) Specification 2017.
2
Commencement
(1)
Each provision of this order 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
specification
The day after this specification is
registered.
Note:
(2)
3
This table relates only to the provisions of this specification as originally made. It
will not be amended to deal with any later amendments of this specification.
Any information in column 3 of the table is not part of this specification.
Information may be inserted in this column, or information in it may be
edited, in any published version of this specification.
Authority
This specification is made under subsection 61(5D) of the Therapeutic
Goods Act 1989.
4
Interpretation
In this specification:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as given in the Therapeutic Goods
Regulations 1990.
classification has the same meaning as given in the Therapeutic Goods
(Medical Devices) Regulations 2002.
device nomenclature system code has the same meaning as given in
Therapeutic Goods (Medical Devices) Regulations 2002.
expiry date has the same meaning as given in the Therapeutic Goods
Regulations 1990.
intended purpose has the same meaning as given in Therapeutic Goods
(Medical Devices) Regulations 2002.
Therapeutic Goods Information (Laboratory Testing) Specification 2017
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Section 5
sample has the same meaning as given in Therapeutic Goods Regulations
1990.
trade name has the same meaning as given in Therapeutic Goods
Regulations 1990.
variant has the same meaning as given in Therapeutic Goods (Medical
Devices) Regulations 2002.
Note
A number of expressions used in this specification are defined in the Act,
including the following:
(a) biological number;
(b) device number;
(c) included in the Register;
(d) indications;
(e) listing number;
(f) manufacture;
(g) manufacturer;
(h) product information;
(i) quality;
(j) Register;
(k) registration number;
(l) sponsor;
(m) supply;
(n) therapeutic goods; and
(o) therapeutic goods information.
5
Therapeutic goods information
The kinds of therapeutic goods information mentioned in Schedule 1 are
specified under subsection 61(5D) of the Act for the purposes 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).
Therapeutic Goods Information (Laboratory Testing) Specification 2017
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Schedule 1
Schedule 1
Specified kinds of therapeutic goods
information
(section 5)
For each item in column 1 of the following table, the kinds of therapeutic goods information
specified in column 2 have the description given in column 3.
Kinds of therapeutic goods information
Column 1
Item
Column 2
Information
Column 3
Description
1
description of samples
of therapeutic goods
in relation to samples of therapeutic goods
included on the Register, the following
information, as applicable:
(a) trade name, name and quantity of active
ingredients, strength, size, dosage form and
model of the therapeutic goods;
(b) sponsor name;
(c) manufacturer name;
(d) registration number, listing number,
biological number or device number;
(e) type, category, class or classification of the
therapeutic goods;
(f) indications for which the therapeutic goods
are included in the Register;
(g) batch number, batch code, lot number or
serial number of the samples tested;
(h) date of manufacture of the samples tested;
(i) expiry dates of the samples tested;
(j) intended purpose for which the therapeutic
goods are included in the Register;
(k) description, or functional description, of the
therapeutic goods included in the Register;
(l) device nomenclature system code, term and
definition of the therapeutic goods;
(m) unique product identifier given to the
therapeutic goods by the manufacturer to
identify the goods and any variants of those
goods;
(n) names of ingredients or components used in
the manufacture of the therapeutic goods;
(o) information relating to any sterilisation
method used in relation to the therapeutic
goods;
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Schedule 1
Kinds of therapeutic goods information
Column 1
Column 2
Item
Information
Column 3
Description
2
test reason
(p) information relating to the software and
firmware necessary for the proper
application of the therapeutic goods,
including the relevant version; and
(q) information relating to the supply and
manufacture of therapeutic goods relevant
to the testing including, but not limited to,
product information, consumer medicines
information, directions for use, instructions
for use, operational manuals, advertising
material, and packaging information; and
in relation to samples of therapeutic goods that
are not included in the Register, the following
information, as applicable:
(a) a description of the physical appearance of
the therapeutic goods, including the name,
dosage form or model, and any other
identifying features or characteristics such
as colour, shape, labelling and packaging;
(b) names of ingredients or components used,
or purported to have been used, in the
manufacture of the therapeutic goods; and
(c) information relating to the supply and
manufacture of the therapeutic goods
relevant to the testing including, but not
limited to, directions for use, instructions for
use, operational manuals, and advertising
material
the reason for testing the therapeutic goods
3
test description
4
test date
5
test results
the name and description of the tests performed,
including information relating to the scope of
the tests and any applicable standards relevant
to the testing
the date or date ranges in which the testing was
performed on the samples
a summary of test results and compliance with
relevant aspects of the labelling requirements
applicable to the therapeutic goods under the
Act, including whether or not the samples
passed or failed and, in relation to the samples
that failed, general information about the aspect
of testing that those samples failed against
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Schedule 1
Kinds of therapeutic goods information
Column 1
Item
Column 2
Information
Column 3
Description
6
test outcome
7
related quality, safety and
efficacy information
a summary of the outcome of the testing, and
any other subsequent action or investigation
undertaken, including action undertaken by the
Secretary, sponsor or manufacturer in response
to the test results
quality, safety and efficacy information,
including information about the supply or
manufacture of therapeutic goods or the class of
therapeutic goods, that is relevant to the test
reason, the test results or the test outcome for
the samples of the therapeutic goods
Note
1.
All legislative instruments and compilations are registered on the Federal Register of
Legislation kept under the Legislation Act 2003. See http://www.legislation.gov.au
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