Document ID: chunk:federal_register_of_legislation:F2024C00959:clause:6_6
Version: federal_register_of_legislation:F2024C00959
Segment Type: clause
Provision Reference: sch 6 cl 6
Character Range: 317954–320919

6                                                                                                                                                        Application for:                                                                                                                                                                                                                                                                              8 months                                                                                             12 months                                                                                                    $700                                                                                                           $6,406
                                                                                                                                                         (a) registration of a chemical product containing an approved active constituent and approval of the product label; or
                                                                                                                                                         (b) registration of a chemical product, approval of the active constituent in the chemical product and approval of the product label; or
                                                                                                                                                         (c) registration of a chemical product and approval of the product label;
                                                                                                                                                         if:
                                                                                                                                                         (d) the chemical product is closely similar to a registered chemical product; and
                                                                                                                                                         (e) chemistry and manufacture data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product; and
                                                                                                                                                         (f) for an application mentioned in paragraph (b)—the active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopoeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia; and
                                                                                                                                                         (g) for an application mentioned in paragraph (c)—a separate application for the approval of the active constituent in the chemical product has been lodged