Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe

Complementary medicines: Cancellations from the ARTG following compliance review

30 September 2014

Section 60 of the Therapeutic Goods Act 1989 (the Act) provides for a person whose interests are affected by an initial decision (which includes a decision by the Secretary to cancel the listing of a product from the ARTG) to request an internal review of the decision within 90 days by the Minister/Parliamentary Secretary. Such a person can also seek a review by the Administrative Appeals Tribunal (AAT) of the decision by the Minister/Parliamentary Secretary on the internal review.

2014: Sep | Jul | May | Apr | Mar | Jan

September 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
26/09/14 107390 Child Cough & Phlegm Drink Newlite Enterprises Pty Ltd Cancelled under s30(2)(e) of the Act

The goods do not conform to a standard applicable to the goods.

26/09/14 116466 K.P.24 Natural Head Lice Mousse Pharmacare Laboratories Pty Ltd Cancelled under s30(2)(ba) of the Act

As there was insufficient evidence to support the indications for the product, the certification made under s26A(2)(j) was incorrect.

15/09/14 213272 Body & Health Essentials Maxi Organic Red Grapeseed Body & Health Essentials Pty Ltd Cancelled under s30(1C) of the Act

The sponsor failed to comply within the required timeframe with a notice under section 31 requiring it to provided information about whether the product should have been listed.

July 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
11/07/2014 95546 Sooth and Comfort Dietary Supplement Newlite Enterprises Pty Ltd Cancelled under s30(2)(b), (ba), (c) & (e)

The goods have changed so they have become separate and distinct from the goods included in the ARTG.

As the presentation of the product was unacceptable, the certification made under s26A(2)(c) was incorrect.

The sponsor failed to comply with a condition of listing under s28(5)(ab) (that the goods would not be advertised for an indication other than those accepted in the Register).

The goods do not conform to a standard applicable to the goods.

May 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
16/05/2014 170915 PM KiddieCal Pharmametics Products A Division of Max Biocare Pty Ltd Cancelled under s30(2)(ba) As there was insufficient evidence to support the indications for the product, the certification made by the applicant under s26A(2)(j) was incorrect.

April 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
30/04/2014 211423 Milk Thistle 35000 Jo Jo International Pty Ltd Cancelled under s30(1C) The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed.
30/04/2014 124073 Qianlietong Capsule Newlite Enterprises Pty Ltd Cancelled under s30(1C) The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed.

March 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
06/03/2014 188536 Recovery e21 Joint Health Arcadian Nutraceuticals Pty Ltd Cancelled under s30(2)(e) The goods did not conform to a standard applicable to the goods as the label did not comply with the Therapeutic Goods Order No. 69 (TGO 69).

January 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
31/01/2014 166634 Trans - B Secretlife Biotech Corporation Pty Ltd Cancelled under s30 (1C) of the Act The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed.
31/01/2014 207112 Premium Shark Cartilage Australian Medicinal Foods Co Cancelled under s30 (1C) of the Act The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed.

Previous year cancellations from the ARTG following compliance review

Top of page

Content last updated: Tuesday, 30 September 2014

Content last reviewed: Tuesday, 30 September 2014

Web page last updated: Tuesday, 30 September 2014

URL: http://www.tga.gov.au/industry/cm-cancellations-cr.htm