Australia – Updates to variations to prescription medicines guidance and e-form

The TGA Business Services online application system for variations to prescription medicines was updated on 10 July 2019. This was the second part of a staged release of updates and minor performance improvements. This release includes the addition of new variation types. Updated guidance has now been published – Variations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data

What have we updated now?

Extension of indications to align with a reference product

Extension of indications to align with a reference product has been added to the Variation e-form. Before the update if you were submitting these applications you were required to download and complete a pdf form. For further information see the updated guidance…