Cancellations from the ARTG following compliance review
From 1 July 2012
20 May 2013
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 name | Type of cancellation | Grounds for cancellation | Comments |
|---|---|---|---|---|---|---|
| 17/05/2013 | 177683 | Inner Health Candex | Health World Limited | Cancelled under s.30(2)(ba) & (e) | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act. | |
| 08/05/2013 | 181750 | Myadec Primetime 50+ Formulation | Myadec Pty Ltd | Cancelled under s.30(2)(ba) & (e) | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act. | |
| 04/04/2013 | 175898 | Swisse Ultiboost Appetite Suppressant | Swisse Vitamins Pty Ltd | Cancelled under s. 30(2)(ba) and (e) | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. | |
| 27/03/2013 | 169976 | BLOOMS CURCUMIN 600 PLUS with enhanced BioP absorption | Phytologic Pty Ltd | Cancelled under s.30 (2)(ba) & (e) of the Act | As the presentation of the product was unacceptable, the certification made by the applicant under s.26A(2)(c) was incorrect. The goods also did not conform to regulatory requirements relating to advertising (paragraph 30(2)(e)). |
Internal review by the TGA confirmed cancellation decision. Application by the sponsor to AAT for review of the internal review decision withdrawn. |
| 25/02/2013 | 182848 | Fat Eliminator | Thinz Pty Ltd | Cancelled under 30(2)(ba) and (e) | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect (paragraph 30(2)(ba)). The goods also did not conform to regulatory requirements relating to advertising (paragraph 30(2)(e). | |
| 04/01/2013 | 174861 | Energy Slim | World Class Physiques Pty Ltd | Cancelled under Section 30 (1C) | Sponsor failed to comply with notice under section 31 of the Act requiring it to provide information about whether the product should have been listed. | |
| 11/12/2012 | 197065 | Undoit Plus | Undoit com au Pty Ltd | Cancelled under 30(2)(ba), (c) and (e) | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. Failed to comply with a condition of listing under s.28(5)(ab) of the Act | |
| 23/11/2012 | 158491 | Colocap Balance | Colocap Pty Ltd | Cancelled under Subsection 30 (1A) & 30(2) | As the medicine is now required to be included in another part of the Register under ss.10B(1)(a) and ss.10B(7)(b)(i), the medicine has became ineligible for listing s.30(1A)(a) of the Act. | |
| 09/10/2012 | 183342 | BergaMet Mega | DOJS Holdings Pty Ltd | Cancelled under s.30(2)(ba) of the Act | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. | |
| 09/10/2012 | 189665 | Quicktrim Suppress & Burn | Opti-pharm Pty Ltd | Cancelled under s.30(2)(ba) of the Act | As there was insufficient evidence to support the indications for the product, the certification made by the applicant under s.26A(2)(j) was incorrect. | Internal review confirmed cancellation decision. |
| 15/08/2012 | 176366 | Reducta Fatblaster Tablets | Catmedia Pty Ltd | Cancelled under s.30(2)(ba) of the Act | As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s.26A(2)(c) and (j) were incorrect. |
Content last updated: Monday, 20 May 2013
Content last reviewed: Monday, 20 May 2013
Web page last updated: Monday, 20 May 2013
URL: http://www.tga.gov.au/industry/cm-cancellations-cr.htm