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Forms for prescription medicine sponsors

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These forms are for the prescription medicines industry.

Prescription medicines forms

• Annual batch release report for biological prescription medicines
  This form is to be used by sponsors to prepare annual batch release reports for biological prescription medicines as part of the post market monitoring program
• 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.
• 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
• Minor variations to registered prescription medicines: chemical entities and biological medicines
  Application forms for making an application for a variation to a registered prescription medicine
• Module 1: Additional forms and proformas
  Additional forms supporting the CTD Module 1
• Notification of a proprietary ingredient
  Use to request proprietary ingredient formulations to be entered onto the ARTG
• 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
• 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.
• 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
• Summary of a bioavailability or bioequivalence study
  Use to submit a summary of a bioavailability or bioequivalence study
• Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom
  Use this form for products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell

Related forms

• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005
• Client details form
  This form should be completed by or for each client involved with the supply of therapeutic goods in Australia for which the TGA requires address details
• Request to transfer the sponsorship of an ARTG entry
  Use by the accepting company and the relinquishing company to request to transfer the sponsorship of an ARTG entry