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: 7219–8871

1                                                                                          The relevant person must:
                                                                                          (a) confirm the absence of aristolochic acids in each batch of the medicine by undertaking chemical analysis of either the raw material or the final medicine, using Liquid Chromatography Mass Spectrometry (LC-MS), where the chemical analysis (the confirmatory evidence):
                                                                                             (i) adheres to best practice according to contemporary scientific literature; and
                                                                                             (ii) is traceable to the batch of the medicine; and
                                                                                             (iii) includes all relevant details of the methodology used, such as analytical method validation data; and
                                                                                             (iv) includes the raw results, such as data for a reference standard, the sample and a sample spiked with aristolochic acid at the reporting level; and
                                                                                          (b) provide the confirmatory evidence, or a copy of the confirmatory evidence, to the TGA; and
                                                                                          (c) not supply a batch of the medicine in Australia until the confirmatory evidence for that batch is approved in writing by the TGA.