Forms for prescription medicine sponsors

These forms are for the prescription medicines industry. For a complete list of forms, see: Forms

A C D J N P R S T

A

• Annual product report for biological prescription medicines
  This form is to be used by sponsors to prepare annual product reports for biological prescription medicines as part of the post market monitoring program
• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005

C

• Certified product details (CPD) - Biological prescription medicines
  This proforma is to be used by sponsors to prepare certified product details (CPD) for biological prescription medicines when requested by the TGA.
• Certified product details (CPD) - Chemical prescription medicines
  This proforma is to be used by sponsors to prepare certified product details (CPD) for chemical prescription medicines when requested by the TGA.
• CTD Module 1: Additional forms and proformas
  Additional forms supporting the CTD Module 1

D

• Designation checklist: for sponsor seeking orphan drug designation
  This checklist is intended to assist applicants to determine if they have provided all of the necessary information to allow the TGA to make an informed decision on the designation application
• Determination checklist: for sponsor seeking priority review determination
  This checklist is intended to assist applicants to determine if they have provided all of the necessary information to allow the TGA to make an informed decision on the priority review determination application
• Determination checklist: for sponsor seeking provisional determination
  This checklist is intended to assist applicants to determine if they have provided all the necessary information to allow the TGA to make an informed decision on the determination application
• Drug Master File (DMF) – Administrative Details Form
  This form is to be used by industry stakeholders (e.g manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA, It is not required if the DMF is submitted in eCTD format.

J

• Justification for a particular route of evaluation
  Use when an applicant wishes to have their product or substance evaluated by an area of the TGA other than as specified in Schedule 10 to the Therapeutic Goods Regulations

N

• Notification of a change in sponsorship
  Use this form to notify of a change in the sponsorship of an ARTG entry
• Notification of a new proprietary ingredient
  Use to supply TGA with information about a proprietary ingredient
• Notification of proposal to submit supplementary data & submission of supplementary data
  Use to notify the TGA of a proposal to submit supplementary data and to submit supplementary data

P

• Prescription medicine registration form
  Use to apply for registration or to vary the conditions of registration for prescription medicines
• Pre-submission Planning Form (PPF)
  The Pre-submission Planning Form and information about how to complete it
• Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
  Use this form to propose an amendment to the Required Advisory Statements for Medicine Labels (RASML)
• Proposed Australian Approved Name (AAN) application form
  Use this form to apply for an Australian Approved Name
• Proposed Australian Biological Name (ABN) application form
  Use this form to apply for an Australian Biological Name

R

• Report of the manufacture of exempt therapeutic goods
  For sponsors of exempt therapeutic goods to inform the TGA of the details of the supply of such goods on a quarterly basis, as required by item 5 of Schedule 5A to the Therapeutic Goods Regulations 1990
• Request to cancel an entry/entries from the Australian Register of Therapeutic Goods (ARTG)
  Use this form to request cancellation of an entry on the ARTG

S

• Submission dossier checklist for prescription medicines
  The submission dossier checklist is not mandatory for the submission of applications, however it can be used to assist you to standardise the format, packaging and dispatch of both hard copy and electronic copy submission dossiers
• Summary of a bioavailability or bioequivalence study
  Use to submit a summary of a bioavailability or bioequivalence study

T

• TGA Business Services forms
  Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services