Document ID: chunk:federal_register_of_legislation:F2015L01752:body:0:p2
Version: federal_register_of_legislation:F2015L01752
Segment Type: other
Provision Reference: 
Character Range: 3506–5746

to the application, including analysis  The 6‑unit fee ($1,155), per module type*.
                                                                          If the assistance involves more than one module type, more than one 6‑unit fee applies.
Meeting between the applicant and the APVMA                               The 2‑unit fee ($385)

  * A module type is a type of module set out in one of items 2 to 10 of Schedule 7 to the Regulations.
Where:
          (a)   Tier 1 pre-application assistance is for applicants seeking guidance in the early stages of preparing for the making of an application. It is to assist applicants in clarifying the types of regulatory assessments likely to be conducted for a particular submission to inform that applicant in collating relevant information and data likely to be necessary.
          (b)   Tier 2 pre-application assistance includes all the aspects of Tier 1 with further provision for applicants who are seeking guidance in matters relating to the types of information and data that may be appropriate in a particular submission.
          (c)   Tier 3 pre-application assistance includes all the aspects of Tier 1 and Tier 2 with further provision for applicants seeking appraisal of the specifics of conducting studies and finalisation of project plans for Global Joint Reviews.
  Examples of the application of the above criteria to particular cases:
 (a) The 3-unit fee of $577.50 applies for the provision of Tier 1 pre-application assistance consisting of administration and a written response.
 (b) The 5-unit fee of $962.50 applies for the provision of Tier 2 pre-application assistance consisting of administration and a written response.
 (c) The 7-unit fee of $1,347.50 applies for the provision of Tier 2 pre-application assistance consisting of administration, a written response and a meeting.
 (d) The 9-unit fee of $1,732.50 applies for the provision of Tier 3 pre-application assistance consisting of administration, 1 module type (e.g. efficacy and safety) and a meeting.
 (d) The 13-unit fee of $2,502.50 applies for the provision of Tier 3 pre-application assistance consisting of administration, 2 module types (e.g. efficacy and safety, and residues) and no meeting.