4Interpretation

4 Interpretation

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) British Pharmacopoeia;

(b) European Pharmacopoeia;

(c) medicine;

(d) Register;

(e) United States Pharmacopeia-National Formulary.

(1) In this instrument:

Act means the Therapeutic Goods Act 1989.

active ingredient, or A, for a medicine, has the same meaning as in the Regulations.

code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.

excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.

Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.

homoeopathic preparation has the same meaning as in the Regulations.

homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.

Regulations means the Therapeutic Goods Regulations 1990.

TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at www.ebs.tga.gov.au.

Therapeutic Goods Administration has the same meaning as in the Regulations.

(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are:

(a) terms from the code tables under the heading Product Warning; and
(b) not required to be reproduced in a warning statement on the label of a medicine.

Note: Examples of these terms include the following:

(a) (ARGIN1);

(b) (CHILD3);

(c) (GLUTEN);

(d) (PEANUT);

(e) (PREGNT).