Drugs and Devices Registration Services

Follow the links below to find information on services related to requirements, standards and approval processes for therapeutic goods, drugs and devices.

Reviewed March 2009

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14 Resources Found
Results 1 to 14 displayed.
Title:   Fees & payments
Publisher:   Australian Government Department of Health and Ageing
Description:   Summary of TGA fees and charges including explanatory notes
Date:   Jul 2009
Title:   Summary of fees and charges at 10 July 2009
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA collects its revenue primarily through annual charges, evaluation and assessment fees and licence fees. Each year the TGA meets with representatives of each of the four major industries to discuss and agree the TGA's schedule of fees and charges for the forthcoming financial year.
Date:   May 2009
Title:   Facility registration - human cells, tissues, cell and tissue-based products
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA requests facilities and individuals engaged in or responsible for the retrieval/collection, processing, storage, labelling and packaging, product testing or release for supply of human tissue and cell based products for therapeutic purposes, or for the screening of cell or tissue donors, in Australia, to provide the TGA with current information relating to the facility/individual and its activities by completing and returning the attached form.
Date:   Sep 2008
Title:   Health Products
Publisher:   HealthInsite Topic Page
Description:   Links to information about directories and services related to health products, including therapeutic goods and devices, equipment and supplies.
Date:   Jun 2008
Title:   Advertising approval application forms
Publisher:   Australian Government Department of Health and Ageing
Description:   This form has been prepared to assist in the process of applying for the approval of advertisements in 'specified media' to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies.
Date:   Nov 2007
Title:   Differences between the Australian and European Union regulatory systems (1) - Fundamental differences and classification
Publisher:   Australian Government Department of Health and Ageing
Description:   This Fact Sheet is one of a series that covers the differences between the Australian and EU Regulatory Systems.
Date:   Oct 2006
Title:   Differences between the Australian and European Union regulatory systems (2) - Essential principles
Publisher:   Australian Government Department of Health and Ageing
Description:   This fact sheet is one of a series that covers the differences between the Australian and EU Regulatory Systems.
Date:   Oct 2006
Title:   Transmissible Spongiform Encephalopathies (TSEs) questionnaire for sponsors
Publisher:   Australian Government Department of Health and Ageing
Description:   This questionnaire has been designed by the TGA in consultation with Australian industry bodies to facilitate the collection of data to enable Sponsors to self-certify their therapeutic goods against the TGA's 'Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSE)'.
Date:   Dec 2004
Title:   Access to unapproved therapeutic goods - Special access scheme
Publisher:   Australian Government Department of Health and Ageing
Description:   These documents describe how to obtain approval for the supply of an unapproved therapeutic good (medicine or medical device) in Australia under the Special Access Scheme and how to obtain the product once approval for supply has been given.
Date:   Oct 2004
Title:   Access to unapproved therapeutic goods - clinical trials
Publisher:   Australian Government Department of Health and Ageing
Description:   These documents describe the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
Date:   Oct 2004
Title:   Request form for GMP or Quality Systems certificates
Publisher:   Australian Government Department of Health and Ageing
Description:   Form for requesting: GMP Certificate of Compliance, Certified copy of GMP Certificate of Compliance, Quality Systems Certificate, Certified copy of Quality Systems Certificate, and Mutual Recognition Certificate.
Date:   Aug 2004
Title:   Literature based submissions - points to consider
Publisher:   Australian Government Department of Health and Ageing
Description:   Points to consider when making literature based submissions. Literature based submissions will be accepted for the purposes of updating the Product Information documents of drugs with an extensive registration history, either in Australia or overseas.
Date:   Apr 2003
Title:   GMP audit of overseas manufacturer - TGA application form
Publisher:   Australian Government Department of Health and Ageing
Description:   This form should be completed by or for each overseas manufacturer of therapeutic goods who, if based in Australia, would not be exempted from the requirement to hold a licence under Part 4 of the Therapeutic Goods Act 1989.
Date:   May 2001
Title:   Australian medical device requirements under the Therapeutic Goods Act 1989 (version 4) - DR4
Publisher:   Commonwealth Department of Health and Aged Care
Description:   This document describes the information to be supplied by a sponsor in support of an application for the listing of therapeutic devices in the Australian Register of Therapeutic Goods.
Date:   Jun 1998
Results 1 to 14 displayed.