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Complementary medicines: Cancellations from the ARTG following compliance review

22 October 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: Oct | Sep | Jul | May | Apr | Mar | Jan

October 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
22/10/2014 95547 Pe Min Kan Wan Newlite Enterprises Pty Ltd Cancelled from the ARTG under s.30(2)(caa) of the Act The sponsor failed to comply within 14 days after the end of the period specified in a notice under section 31 requiring it to provide information or documents relating to the goods.  
95548 Ling Zhi Capsule
95549 Flu & Cough tablets
95803 Zheng Gu Shu Jing Lu
95804 Cough Be Gone Oral Liquid
95805 Acne Clean Tablets
95806 Arthritis Relief Tablets
107389 Mongnum Shen You Lotion
107391 Cold & Flu Pian
107392 Cough Soother Capsule
107393 Xiao Ke Tablet
107394 Gastrocare Capsule
107395 Hemorrhoid Soother
107396 Itch Stop Cap
107397 Potent Chuanxinlian Pian
107399 Stomach Rectifier Cap
107400 Wu Lin Hua Shi Capsule
107401 Vasculation Tablet
107582 Slim & Fit Capsule
107587 Menopause Capsules
107588 Cough & Phlegm Cleared Drink
107589 Potent Migraine Cap
124071 Wuxushengfasu Pill
124075 Piantoutong Capsule
124168 Baoyingdan Granules
124169 Jiushendan Capsule
124170 Lubianwan Capsule
124172 Qufengyou
124376 Nanbao Capsule
124377 Fukebaifengping Tablet
124378 Neireshiduqing Capsule
124379 Premium Reichi Extract
128110 Baoganling Capsule
128111 Sitengsu Capsule
128731 Hair Tonic (Wuxushengfasu Pill)
128732 Migraine Headache Relief (Piantoutong) Capsule

September 2014

Date cancellation takes effect AUST L No. Product name Sponsor name Type of cancellation Grounds for cancellation Comments
26/09/2014 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.

26/09/2014 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.

15/09/2014 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

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Content last updated: Wednesday, 22 October 2014

Content last reviewed: Wednesday, 22 October 2014

Web page last updated: Wednesday, 22 October 2014

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