1. 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
2. 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 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 11(b) | The estimated average content for each following active ingredient must fall within the respective percentage range relative to the stated content of that active ingredient: Calcium (90 to 110%), phosphorus (90 to 110%), iodine (90 to 110%), copper (90 to 125%), iron (90 to 110%), magnesium (90 to 110%), zinc (90 to 110%), folic acid (90 to 125%), ascorbic acid (90 to 121%), nicotinamide (90 to 115.5%), dl-alpha tocopheryl acetate (90 to 121%), cholecalciferol (90 to 132%), pyridoxine hydrochloride (90 to 121.2%), calcium pantothenate (90 to 115.5%), riboflavine (90 to 121.1%), thiamine nitrate (87.5 to 117.5%), cyanocobalamin (85 to 138%) and biotin (85 to 126.5%). | Goods released for supply prior to 31 July 2013 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 11(c) | There are no dissolution requirements for any active ingredient except for folic acid. | Goods released for supply prior to 31 July 2013 |
Pfizer Australia Pty Ltd | Centrum Advance | 193683 | TGO 78 | 10(b) | The upper limits of the active ingredients lutein and lycopene are not more than 165% of the stated content, rather than the required 120%. | Until further notice |
Centrum Advance 50+ | 193642 |
Bausch & Lomb Australia Pty Ltd | Ocuvite Adult 50+ Capsule | 198670 | 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 |
GNLD | Pro Vitality + | 198326 | TGO 69 | 3(2) | The active ingredients and quantities are not required to be on the individual packets, provided that all other requirements of the Order, including maximum text height are met. | Until further notice |
Blackmores Limited | Blackmores Alive! Men’s Multivitamin | 198733 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export the goods with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: · ‘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 of pharmacist.’ Additionally the label can include the following abridged version of RASML statement 31: · ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’ | Until further notice |
Blackmores Alive! Men’s 50+ Multivitamin | 199198 |
Sanofi-Aventis Consumer Healthcare | Golden Glow Men’s One a day Multivitamin | 199301 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export the goods with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: · ‘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 of pharmacist.’ Additionally the label can include the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’ | Until further notice |
Pfizer Australia Pty Ltd | Centrum for Men | 200421 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export Centrum for Men – AUST L 200421 with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: · ‘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 of pharmacist.’ Additionally the label can include the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’ | Until further notice |
Pfizer Australia Pty Ltd | Centrum for Women | 200414 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export Centrum for Women – AUST L 200214, with a label that includes the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women.' | Until further notice |
Prinz Herget Pty Ltd T/A Natural Therapy Imports | Mutaflor capsules | 194957 | TGO 69 | 3(13)(a) | The particulars referred to in subclause 3(13)(a) must appear on the blister pack label except the batch number and expiry date may be void of the required prefixes. | Applicable to Batch 221590 only |