The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable. Full document...

This Guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is not complete nor is it intended to be the sole source of reference. Full document...

The document DR4 is a guidance document that now applies only to the regulation of therapeutic devices that are regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. Full document...

The guidelines are designed to ensure best practice in managing the phase out of products, especially the timing and recipients of notifications of the deletion. They make recommendations about who to tell, when and what information will be needed. Full document...

This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002. Full document...

The key purpose of this document is to delineate the role of the TGA in export regulation. Part A of the document comprises the policy framework or strategic commitments given by the TGA in relation to export regulation. These support and direct the TGA's export-related actions outlined in Part B. Full document...