1.  The whole of this specification

The day after this specification is registered.

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;

(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