Section 14 and 14a Notice

Between 5th June 2012 and 17th September 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
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
Pfizer Australia Pty Ltd	Centrum Advance 50+	193642	TGO 78	10(b)		Until further notice
Bausch & Lomb Australia Pty Ltd	Ocuvite Adult 50+ Capsule	198670	TGO 78	10(b)	The upper limit in the goods of: Lutein is not more than 135% of the stated content, rather than the required 120%, and 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 Limited	Blackmores Alive! Men’s 50+ Multivitamin	199198	TGO 69	3(2)(g)		Until further notice
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