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This gazette
— pp 2631 - 2634
Section 14 and 14A Notice
Administered by: Health
Published Date 10 Oct 2012
Printed Publication Date 10 Oct 2012

 

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:

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