Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

This guidance is to assist with exporting medicines either for commercial supply, or for non-commercial purposes.

Outlines types of variations that have been determined to pose a very low risk.

We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand

We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand

The reference to the Quarantine Act 1908 in the Section 19A Guidance document has been replaced with reference to the Biosecurity Act 2015.

Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines

The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.

The evaluation plan estimators can be used to approximate the dates of the milestones in the prescription medicine registration process

Guidance about the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma

Guidance for sponsors of all medicines that contain, or are manufactured using materials of animal or human origin