Cancellations and suspensions

Regulatory action due to As the sponsor of the kind of medical device failed to comply with the notice under s.41JA of the Act, requesting the sponsor to give the TGA information relating to the kind of device, within a further 10 working days from the day specified in the notice, the entry was cancelled., effective 01/10/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s. 41FO.As the information supplied with the device did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect., effective 30/09/2013

Regulatory action due to As there was insufficient evidence to support the indications for the product, the medicine was not safe for the purposes for which it is to be used and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(b), (c) and (j) were incorrect. The goods were also not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the TGAC (see item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations)., effective 27/09/2013

Regulatory action due to As the device labelling did not comply with the essential principles, the certification made under s.41FD (d) was incorrect.As the sponsor failed to provide evidence that conformity assessment procedure has been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect.As the promotional material did not comply with the Therapeutic Goods Advertising Code 2007, the certification made under s.41FD(h) was incorrect., effective 24/09/2013

Regulatory action due to As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect., effective 23/09/2013

Regulatory action due to As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD (f) and (g) were incorrect., effective 20/09/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.As the device labelling did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s.41FO.As the sponsor failed to supply evidence that conformity assessment procedures have been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect., effective 13/09/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect., effective 12/09/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect., effective 31/08/2013

Regulatory action due to 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 s26A(2)(c) and (j) were incorrect., effective 16/08/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified and the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certifications made under s.41FD(c) and (f) were incorrect., effective 05/08/2013

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made by the applicant under s.41FD(c) was incorrect., effective 12/07/2013

Regulatory action due to 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 s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 05/07/2013

Regulatory action due to 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., effective 02/07/2013

Regulatory action due to 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., effective 28/06/2013

Regulatory action due to The goods are not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the TGAC (see item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations). The sponsor has failed to comply with a condition of listing under s28(5)(ab) (that the goods would not advertise the goods for an indication other than those accepted in the Register)., effective 14/06/2013

Regulatory action due to The goods: are not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the TGAC (see item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations); have changed so that they have become separate and distinct from the goods in the ARTG. The sponsor has failed to comply with a condition of listing under s28(5)(ab) (that the goods would not advertise the goods for an indication other than those accepted in the Register). The certification under s26A(2)(c) (that the presentation of the goods is not unacceptable) is incorrect., effective 14/06/2013

Regulatory action due to The goods: have changed so that they have become separate and distinct from the goods in the ARTG; and do not conform to a standard applicable to the goods., effective 04/06/2013

Regulatory action due to 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., effective 17/05/2013

Regulatory action due to 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., effective 08/05/2013

Regulatory action due to 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., effective 04/04/2013

Regulatory action due to 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))., effective 27/03/2013

Regulatory action due to 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)., effective 25/02/2013

Regulatory action due to 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., effective 04/01/2013

Regulatory action due to 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., effective 11/12/2012