TOTALCARE (Cancelled under s30(2)(a) and (ba) and 30(1A)(a))
Product name
TOTALCARE
Sponsor
ARTG
177226
Date action takes effect
Compliance action
Complementary medicine cancellation
Type of action
Cancelled under s30(2)(a) and (ba) and 30(1A)(a)
Grounds for regulatory action
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).