The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines.
Module 1.2.1: Application form
This application form must be used for the following Category 1 and COR report-based prescription medicines applications or variations where the dossier includes nonclinical, clinical or bioequivalence data including applications for provisional registration. Exceptions are applications for new prescription medicines, new combinations or extensions of indication:
- extension of indications [C]
- major variation (new dosage form, change/increase in patient group, change in dosage(e.g. dosage amount, frequency of use or dose regimen), 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]
- extension of provisional registration [T]
- transition of provisional registration to full registration [S]
For all other Category 1 and COR report-based applications please use TGA Business Services
(TBS).
Comparable Overseas Regulator (COR) report-based process checklist
If you are submitting a COR report-based application, you must also submit the COR application checklist for each submission.
Source: TGA website