Schedule 1—Amendments
Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Section 4 Transition arrangements
1 Subsection 4(1)
Omit subsection 4(1), substitute:
(1) On and from 31 August 2016 and before 1 September 2020, each medicine to which this Order applies must comply with either:
(a) the requirements specified in this Order; or
(b) the requirements specified in:
(i) Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69), up until 30 June 2017 (inclusive); or
(ii) Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69 (2017)), on or after 1 July 2017.
2 Subsection 4(3)
Omit subsection 4(3), substitute:
(3) Notwithstanding subsections (1) and (2), medicines imported into or manufactured in Australia before 1 September 2020 but supplied by a person other than the sponsor after that date must comply with TGO 69 (2017) if at the time of their release for supply they complied with TGO 69 (2017).
Section 5 Exemptions - Medicines to which this Order does not apply
3 Subsection 5(1)
Insert in subsection 5(1), after paragraph (c):
(ca) intended for use in the treatment of humans in accordance with rules specified for the purposes of subsection 19(7A) of the Act; or
Schedule 1 - Substances or Groups of substances present in medicines that are required to be declared on the label of medicines
4 Schedule 1 (introductory text box)
Insert, after the final sentence under the paragraph starting ‘Column 4’:
Where more than one name (as set out under Column 4) is required to be declared, they may be combined to form simple sentences where appropriate.
5 Schedule 1 (table, Substance name or Group of substances name ‘potassium salts, including: potassium bicarbonate potassium chloride’, Column 2, Circumstances (if any) and additional requirements (if any))
Omit:
‘Circumstance: Where the total potassium content of the dose is greater than 39 mg (1mmol) elemental potassium per dose
Requirement: To declare on the label (in mg) the quantity of elemental potassium per dose’,
substitute:
‘Circumstance: Where the total potassium content of the maximum recommended daily dose is greater than 39 mg (1mmol) elemental potassium.
Requirement: To declare on the label (in mg) the quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine’.
6 Schedule 1 (table, Substance name or Group of substances name ‘sodium salts, including: sodium bicarbonate sodium chloride’, Column 2, Circumstances (if any) and additional requirements (if any))
Omit:
‘Circumstance: Where the total sodium content of the maximum recommended daily dose of the formulation is greater than 120 mg of elemental sodium per dose.
Requirement: To declare on the label (in mg) the quantity of elemental sodium per dose’,
substitute:
‘Circumstance: Where the total sodium content of the maximum recommended daily dose is greater than 120 mg of elemental sodium.
Requirement: To declare on the label (in mg) the quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine’.
7 Schedule 1 (table, Column 1, Substance name or Group of substances name ‘sorbates, including: potassium sorbate sorbic acid’)
Omit ‘sorbates, including: potassium sorbate sorbic acid’, substitute: ‘sorbic acid and sorbic acid salts, including: potassium sorbate’.
8 Schedule 1 (table, Column 1, Substance name or Group of substances name ‘sugar alcohols’)
Insert, after ‘sugar alcohols’, ‘(see Note 5A)’.
9 Schedule 1 (Notes)
Insert, after Note 5, ‘Note 5A: Sugar alcohols – It is generally accepted that while glycerol is a sugar alcohol, it does not have a laxative effect. Therefore, glycerol is not required to be declared in relation to sugar alcohols and their associated laxative effect.’
Schedule 3 – Specified Units for Enzymes
10 Schedule 3 (Column 1, Unit, ‘PU’)
Insert ‘million’ before ‘PU’.
11 Schedule 3 (Column 2, Unit Description, ‘Papain units’)
Insert ‘Million’ before ‘Papain units’.