Document ID: chunk:federal_register_of_legislation:F2022L01758:clause:1_1
Version: federal_register_of_legislation:F2022L01758
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 5875–7219

1                                    Where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the medicine with paragraphs (a) and (b) of item 7 of the table in Schedule 4 to the Regulations, the relevant person must:
                                       (a) hold one of the following to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the medicine:
                                          (i) adequate supplementary in-vitro testing data; or
                                          (ii) relevant testing data from an independent testing laboratory on a comparable formulation; or
                                          (iii) other justification acceptable to the TGA; and
                                       (b) provide the information mentioned in paragraph (a) to the TGA within 10 working days of a request by the TGA, or within such other longer period as is agreed with the TGA.

Part 3—Specified listed medicines that may contain aristolochic acids

Conditions applicable to specified listed medicines that may contain aristolochic acid
Column 1                                                                                Column 2
Item                                                                                    Conditions