Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p8
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 20091–22969

Item Number (GTIN) for the medicine as allocated under the GS1 System; and
            2.           identifies different product variants and differentiates between different strengths, pack sizes and dose forms;
            3.           is formatted as one of the GS1 Bar Codes specified within the GS1 General Specification, which includes 2D / Matrix bar codes such as GS1 DataMatrix;

              Note: The machine readable code may also include additional information such as batch number and expiry date details.

       main label means:
            1.           where there are two or more labels or two or more portions of a single label - that label or portion of the label where the name of the medicine is more or most conspicuously shown; or
            2.           where the name of the medicine is equally conspicuous on two or more labels or portions of a label – each label or portion;

       medical gas means a gas or a combination of gases presented for treating or preventing disease or administered to humans with a view to making a

       medical diagnosis or for the purpose of restoring, correcting or modifying physiological functions in humans;

       medicine has the same meaning as in the Act;

       name and contact details in respect of a sponsor or distributor, means

           (a) the name of the sponsor or distributor and sufficient information to allow the sponsor or distributor to be uniquely identified so as to facilitate public contact on matters of complaint, use or general enquiry. The contact details must include information such as the city or suburb of the sponsor's/distributor's principal place of business in Australia (not being a post office, cable, telegraphic or code address). The Australian telephone number, website or email address may also be included; or

           (b) where there has been a change in the sponsor's or distributor's name or contact details in the previous twelve months, the name and contact details of the previous sponsor or distributor;

       name of an active ingredient means the name of the active ingredient that is accepted for inclusion in the Australian Approved Names List;

       name of an excipient means the name of the excipient that is accepted for inclusion in the Australian Approved Names List;

       name of the dosage form means:
            1.            in relation to a medicine that is intended to be, or is, registered goods, the name of the dosage form as entered, or proposed to be entered, in the Register in relation to the medicine; and
            2.           in relation to a medicine that is not entered in the Register, the name of the pharmaceutical form of the medicine;

       name of the medicine means the following:
           (a) where the medicine is intended to be, or is, entered in the Register - the name of the medicine intended to