Complementary medicines: Cancellations from the ARTG following compliance review

13 November 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.

Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
10/11/14 161978 Dynamiclear Rapid Dynamiclear Pty Ltd Cancelled from the ARTG under s.30(2)(aa), 30(2)(ba) and 30(2)(e) of the Act It appeared to the Secretary that the presentation of the goods was unacceptable. As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect. The goods do not conform to a standard applicable to the goods.

The sponsor has requested an internal review of this decision.

Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
22/10/14 124170 Lubianwan capsule 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.

22/10/14 124071 Wuxushengfasu Pill 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.

22/10/14 107589 Potent Migraine Cap 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.

22/10/14 107588 Cough & Phlegm Cleared Drink 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.

22/10/14 107587 Menopause capsules 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.

22/10/14 107582 Slim & Fit capsule 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.

22/10/14 107401 Vasculation tablet 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.

22/10/14 107400 Wu Lin Hua Shi capsule 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.

22/10/14 107399 Stomach Rectifier Cap 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.

22/10/14 107397 Potent Chuanxinlian Pian 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.

22/10/14 124075 Piantoutong capsule 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.

22/10/14 124168 Baoyingdan Granules 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.

22/10/14 128732 Migraine Headache Relief (Piantoutong) capsule 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.

22/10/14 128731 Hair Tonic (Wuxushengfasu Pill) 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.

22/10/14 128111 Sitengsu capsule 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.

22/10/14 128110 Baoganling capsule 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.

22/10/14 124378 Neireshiduqing capsule 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.

22/10/14 124377 Fukebaifengping tablet 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.

22/10/14 124376 Nanbao capsule 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.

22/10/14 124172 Qufengyou 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.

22/10/14 124169 Jiushendan capsule 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.

22/10/14 107396 Itch Stop Cap 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.

22/10/14 107395 Hemorrhoid Soother 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.

22/10/14 124379 Premium Reichi Extract 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.

22/10/14 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.

22/10/14 95548 Ling Zhi capsule 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.

22/10/14 95549 Flu & Cough tablets 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

22/10/14 95803 Zheng Gu Shu Jing Lu 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.

22/10/14 95804 Cough Be Gone Oral Liquid 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.

22/10/14 95805 Acne Clean tablets 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.

22/10/14 95806 Arthritis Relief tablets 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.

22/10/14 107389 Mongnum Shen You Lotion 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.

22/10/14 107391 Cold & Flu Pian 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.

22/10/14 107392 Cough Soother capsule 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.

22/10/14 107393 Xiao Ke tablet 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.

22/10/14 107394 Gastrocare capsule 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.

Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type 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.

Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
11/07/14 95546 Sooth and Comfort Dietary Supplement Newlite Enterprises Pty Ltd Cancelled under s.30(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 s.26A(2)(c) was incorrect.
The sponsor failed to comply with a condition of listing under s.28(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

Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
16/05/14 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.
Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
30/04/14 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.
30/04/14 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.
Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
06/03/14 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).
Date cancellation takes effect AUST L No. Product Name Sponsor Cancellation Type Grounds for cancellation Comments
31/01/14 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.
31/01/14 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.

Previous year cancellations from the ARTG following compliance review

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