Application form to register or vary the registration of prescription medicines

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.