Source: https://www.legislation.gov.au/Details/F2016C00898
Timestamp: 2019-11-18 00:43:07
Document Index: 494564157

Matched Legal Cases: ['arts 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016
Details: F2016C00898
- F2016C00898
No. 2 of 2016 Determinations/Other as amended, taking into account amendments up to Therapeutic Goods (Permissible Ingredients) Amendment (2016 Measures No. 1) Determination 2016
Therapeutic Goods (Permissible Ingredients) Amendment (2016 Measures No. 1) Determination 2016 - F2016L01588
Registered 11 Oct 2016
Start Date 06 Oct 2016
Date of repeal 31 Jan 2017
Repealed by Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017
F2016C00898
Compilation date: 6 October 2016
Includes amendments up to: F2016L01588
Registered: 11 October 2016
Volume 1: section 1–3, Schedule 1, Parts 1 and 2 (items 1–714)
Volume 2: Schedule 1, Part 2 (items 715–2122)
Volume 3: Schedule 1, Part 2 (items 2123—2761)
Volume 4: Schedule 1, Part 2 (items 2762–3543)
Volume 5: Schedule 1, Part 2 (items 3544–4950)
Volume 6: Schedule 1, Part 2 (items 4951–5160)
This is a compilation of the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 that shows the text of the law as amended and in force on 6 October 2016 (the compilation date).
This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016.
European Pharmacopeia is as defined under the Act.
(b) the safety of the ingredient must have been assessed against the principles and requirements detailed in the European Pharmacopeia general monograph 1483: Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.
(a) formulated for use on the principle that is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous etha or glycerol; or
Part 2—Table 1
(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tosilate.
2‑BUTYL‑4,4,6‑TRIMETHYL‑1,3‑DIOXANE
2-ETHYL METHYL BUTYRATE
2‑METHYL‑4‑(2,2,3‑TRIMETHYL‑3‑CYCLOPENTENYL)‑2‑BUTEN‑1‑OL
2‑METHYL‑4‑(CAMPHENYL‑8)‑CYCLOHEXANONE
2,2‑DIMETHYL‑3‑(3‑METHYL‑2,4‑PENTADIENYL)‑OXIRANE
4,5‑DIMETHYL‑3‑HYDROXY‑2(5H)FURANONE
6‑BUTYL‑3,6‑DIHYDRO‑2,4‑DIMETHYL‑2H‑PYRAN
The concentration in the medicine must be no more than 1.5%.
- (VIT) 'Vitamins can only be of assistance if the dietary vitamin intake is inadequate.' or 'Vitamin supplements should not replace a balanced diet.'
Permitted for use as a colour for topical use.
(S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate ditosylate.
(S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetrasulfate ditosylate dihydrate.
Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.
The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use.
Permitted for use as a colour for oral and topical use.
When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe barbadensis.
- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect)
- (S) 'If symptoms persist consult your healthcare practitioner' (or words to that effect)
- (LAX1) 'Drink plenty of water' (or words to that effect)
- (S) 'If symptoms persist consult your healthcare practitioner' (or words to that effect).
ALOES BARBADOS
When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloes barbados.
Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.
Permitted for use as a colour for oral and topical use
Only for use as an active homoepathic or excipient ingredient.
When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopeia.
Only for use as an active ingredient in homoeopathic medicines or as an uncompounded medicine substance packed for retail sale.
When used as an uncompounded medicine substance the ingredient must comply with an uncompounded substance monograph of the British Pharmacopeia.
AMMONIUM PHOSPHATE - MONOBASIC