Document ID: chunk:federal_register_of_legislation:F2023C00019:clause:1_19:p2
Version: federal_register_of_legislation:F2023C00019
Segment Type: clause
Provision Reference: sch 1 cl 19 (pt 2/2)
Character Range: 28785–30061

that is:
 (a) required under a relevant instrument to be included on the label of the medicine; and
 (b) reasonably necessary to inform a decision of a consumer to purchase the medicine.
relevant instrument means one or more of the following:
 (a) an instrument made under subsection 3(5A) of the Act relating to medicine advisory statements;
 (b) a determination made under section 26BB of the Act relating to permissible ingredients;
 (c) a determination made under section 26BF of the Act relating to permissible indications;
 (d) a condition of registration or listing imposed under the Act in relation to the medicine;
 (e) TGO 92.
Note 1: The instrument made under subsection 3(5A) of the Act that is in force at the commencement of this Code is the Therapeutic Goods (Medicines Advisory Statements) Specification 2021.
Note 2: The following determinations made under sections 26BB and 26BF of the Act, respectively, are in force at the commencement of this Code:
(a) Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021;
(b) Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021.
Note 3: The instruments mentioned in notes 1 and 2 are legislative instruments published on the Federal Register of Legislation at www.legislation.gov.au.