COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14a Notice
Between 28th October 2011 and 6th February 2012, the delegate of the Secretary of the Department of Health and Ageing gave consent pursuant to sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the following:
- The supply, importation of the therapeutic goods or classes of therapeutic goods specified in Column 2 of the Table and with the Australian Register of Therapeutic Goods number (ARTG No.) specified in Column 3 of the Table; and
- Without conforming to those clauses, specified in Column 5 of the Table, of the standard, specified in the Column 4 of the Table otherwise applicable to the goods.
Pursuant to section 15(1) of the Act, consent is subject to the conditions specified in Column 6 of the Table and consent is given for the period specified in Column 7 of the Table, provided all other requirements of the standard are met.
Column 1 | Column 2 | Column 3 | Column 4 | Column5 | Column 6 | Column 7 |
Sponsor | Goods or Classes of Goods | ARTG No. | Standard | Clause | Conditions | Period for which consent is given |
Health World Limited | Ethic Nutrients Immune Defence | 189795 | TGO 69 | 3 (2)(g) | The goods may be supplied with a label that does not include the label statements required by Required Advisory Statements for Medicine Labels in relation to products containing vitamin A that are intended for use by adults, provided the following condition are met: - The label includes the advisory statement ‘Warning: If pregnant or considering becoming pregnant consult your healthcare practioner before taking vitamin A as when in excess of 3000 µg RE for women and 900 µg RE for men’; - The label includes statements that “µg = micrograms” and “RE = retinol equivalents”; and, - all other requirements of the Order are met. | Until Further Notice |
Sanofi-Aventis Healthcare Pty Ltd | Golden Glow Men’s One a day Multivitamin | 191120 | TGO 69 | 3 (2)(g) | The sponsor may supply, import or export the goods with a product label that does not included the Required Advisory Statement for Medicine Labels (RASML) statements 32 and 33, as outlined below: a) ‘Warning – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.’ ‘If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.’ Along with consent for the sponsor to supply, import or export the goods with label that includes the abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalent for men’ | Until further notice |
Bausch & Lomb Australia Pty Ltd | Ocuvite Adult 50+ | 189300 | TGO 78 | 10 (b) | The upper limit in the goods of: i) lutein is not more than 135% of the stated content, rather than the required 120%, and, ii) Zeaxanthin is not more than 190% of the stated content, rather than the required 120% | Until Further Notice |
Integria Healthcare | Thompson’s B5 500mg | 114599 | TGO78 | 10(d) | Batch Number 1112063, the disintegration time for the tablets is not more than 27 minutes, rather than 15 minutes as required by the British Pharmacopoeia general monograph for tablets | Until further notice |
BioMedica Nutraceuticals Pty Ltd | UltraLiv | 175153 | TGO 78 | 9 (2) | The product is not required to comply with the dissolution requirements for folic acid of the United States Pharmacopeia-National Formulary, chapter <2040> “Disintegration and Dissolution of Dietary Supplements”. | Until 17 January 2014 |
Nu Skin Enterprises Australia Inc | LifePak Prime & LifePak | 174610
& 176310 | TGO 69 | 3(12)(b) | The requirements specified in subclauses 3(2)(b) and (c), that the names and quantity of the active ingredients in the goods are not required to appear on the individual sachet label, provided that all other requirements are met. | Until further notice |
Swisse Vitamins Pty Ltd | Swisse Men’s Ultivite Multivitamin, Mineral & Antioxidant with Herbs 50+ Years (Tablets) | 1690721 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export the goods with a product label that does not included the Required Advisory Statement for Medicine Labels (RASML) statements 32 and 33, as outlined below: b) ‘Warning – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.’ c) ‘If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.’ | Until further notice |
Swisse Men’s Ultivite Multivitamin Mineral & Antioxidant with Herbs No Iron Iodine | 169034 | |||||
Swisse Men’s Ultivite 65+ Multivitamin, Mineral Antioxidant with Herbs | 187229 | |||||
Swisse Practioner Men’s Ultivite | 193887 | |||||
Swisse Professional Men’s Ultivite-B | 189987 | |||||
Swisse Ultivite Women’s 65+ Multivitamin, Mineral & Antioxidant with herbs | 179193 |