Document ID: chunk:federal_register_of_legislation:C2004A00781:clause:1_12
Version: federal_register_of_legislation:C2004A00781
Segment Type: clause
Provision Reference: sch 1 cl 12
Character Range: 3825–5164

12  Subsection 26A(2)
Repeal the subsection, substitute:

 (2) The applicant must certify that:
 (a) the medicine is eligible for listing; and
 (b) the medicine is safe for the purposes for which it is to be used; and
 (c) the presentation of the medicine is not unacceptable; and
 (d) the medicine conforms to every standard (if any) applicable to the medicine and to every requirement (if any) relating to advertising applicable under the regulations; and
 (e) if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step granted under section 38; and
 (f) the medicine complies with all prescribed quality or safety criteria; and
 (g) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (h) all the manufacturers of the medicine are nominated as manufacturers in the application; and
 (i) the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and
 (j) the applicant holds information or evidence to support any claim that the applicant makes relating to the medicine; and
 (k) the information included in or with the application is correct.