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Prescription medicine registration form

3 August 2020

How to access a pdf or Word document

These forms are available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

Module 1.2.1: Application form to register or vary the registration of prescription medicines

Use this form for the following Category 1 and COR report-based prescription medicines applications or variations where the dossier includes nonclinical, clinical or bioequivalence data:

  • extension of indications [C]
  • major variation (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) [F]
  • change in formulation [G]
  • change in container type (disregarding container size) [G]
  • other variation (requiring evaluation of clinical, nonclinical, or bioequivalence data) [H]
  • variation to Register entry resulting in a change of product information requiring evaluation of clinical, nonclinical, or bioequivalence data [J]

For all other Category 1 (type A, B and D) applications please use TGA Business Services (TBS).

Comparable Overseas Regulator (COR) report-based process checklist

This checklist must be submitted for all COR report-based applications.