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).

• Application for the registration, or to vary the conditions of registration, of prescription medicines (pdf,193kb)
• Application for the registration, or to vary the conditions of registration, of prescription medicines (docx,172kb)

Comparable Overseas Regulator (COR) report-based process checklist

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

• COR report-based process – prescription medicines (pdf,194kb)
• COR report-based process – prescription medicines (docx,163kb)