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 July 2011

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13 Resources Found

Results 1 to 13 displayed.

Title:   Breast Implant Information Line - 1800 217 257
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australian Government has set up a free-call help line for individuals concerned about breast implants.
Date:   Jan 2012
Title:   Health Products
Publisher:   HealthInsite Topic Page
Description:   Links to directories and information about services related to health products, including therapeutic goods and devices, equipment and supplies.
Date:   Sep 2011
Title:   Summary of fees and charges at 1 July 2011
Publisher:   Australian Government Department of Health and Ageing
Description:   Summary of TGA fees and charges for the 2011-2012 financial year
Date:   Sep 2011
Title:   Fees & payments
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA is fully cost-recovered and collects its revenue primarily through annual charges, evaluation and assessment fees and licence fees.
Date:   Apr 2011
Title:   Reforms in the medical devices regulatory framework
Publisher:   Australian Government Department of Health and Ageing
Description:   Consultation on proposals to reform the regulatory framework for medical devices. Closing date: 17 December 2010
Date:   Feb 2011
Title:   Request for certificates or notarised copies of TGA licences and 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:   Jul 2010
Title:   Audit feedback forms (pilot)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA Office of Manufacturing Quality is undertaking a pilot project to seek manufacturers' feedback following TGA audits
Date:   May 2010
Title:   Application for advertising approval
Publisher:   Australian Government Department of Health and Ageing
Description:   This form is for applying for the approval of advertisements in 'specified media' to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies
Date:   Apr 2010
Title:   Access to unapproved therapeutic goods - Special access scheme
Publisher:   Australian Government Department of Health and Ageing
Description:   Describes how to obtain approval for the supply of an unapproved therapeutic good in Australia under the Special Access Scheme and how to obtain the product once approval for supply has been given
Date:   Nov 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:   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 - Clinical trials in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   Describes the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial
Date:   Oct 2004
Title:   Literature-based submissions - points to consider
Publisher:   Australian Government Department of Health and Ageing
Description:   This document will assist sponsors in compiling a literature-based submission (LBS)
Date:   Apr 2003

Results 1 to 13 displayed.