Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected
(WorldNews Politics)

This guidance is subject to the finalisation of legislative amendments. Requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected Introduction This guidance outlines types of variations that have been determined to pose a very low risk. The TGA has concluded that their implementation would not affect the established quality, safety and efficacy of a registered medicine or included biological. These requests (known as `notifications`) still require an application to the TGA. These requests do not require evaluation, but legally must still be approved by the TGA before implementation...