Federal Register of Legislation - Australian Government

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Specifications as made
This instrument specifies kinds of therapeutic goods information, relating to laboratory testing, that may be released to the public by the Secretary under subsection 61(5C) of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 10 Apr 2017
Tabling HistoryDate
Tabled HR09-May-2017
Tabled Senate09-May-2017

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


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Note:          This table relates only to the provisions of this specification as originally made.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

(2)     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.

3            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.

 


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).

 

 


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;

 

Kinds of therapeutic goods information

Column 1

Item

Column 2

Information

Column 3

Description

 

 

(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

2

test reason

the reason for testing the therapeutic goods

3

test description

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

4

test date

the date or date ranges in which the testing was performed on the samples

5

test results

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


 

Kinds of therapeutic goods information

Column 1

Item

Column 2

Information

Column 3

Description

6

test outcome

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

7

related quality, safety and efficacy information

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