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COMPETITIVE AND BUSINESS INTELLIGENCE

AUSTRALIA TGA GUIDANCE DOCUMENTS


Guidance on the GMP clearance of overseas medicine manufacturers - 16th edition (updated)
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. Full document...
13 Mar 2008, Intelligent Agent
Guidance on the GMP clearance of overseas medicine manufacturers (15th edition revised)

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...

31 Jan 2008, Intelligent Agent
A guide to labelling drugs and poisons

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...

11 Dec 2007, Intelligent Agent
"DR4" - Australian medical device requirements under the Therapeutic Goods Act 1989 (version 4) (updated)

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...

20 Nov 2007, Intelligent Agent
Guideline on product discontinuations

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...

18 Oct 2007, Intelligent Agent
Guidance document 13 - Variants for Class III and AIMD medical devices (updated)

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...

24 Aug 2007, Intelligent Agent
Therapeutic Goods Administration (TGA) policy for the export of medicines from Australia

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...

21 Aug 2007, Intelligent Agent

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