You are here Home Guidance and resources Publications hub Publications Submitting applications for extension of indications to align with a reference product Changing the PI of a generic medicine so that the indications match the reference medicine Published 10 July 2019 Listen Print Share LinkedIn Twitter Facebook Email Loading... Applications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.For further information see:Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data; Appendix 1: Variation types - chemical entities. Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data; Process guidance. Topics Prescription medicines Featured in Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
