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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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| Results 1 to 14 displayed. |
| Title: |
Fees & payments
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Summary of TGA fees and charges including explanatory notes
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| Date: |
Jul 2009
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| Title: |
Summary of fees and charges at 10 July 2009
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
May 2009
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| Title: |
Facility registration - human cells, tissues, cell and tissue-based products
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Sep 2008
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| Title: |
Health Products
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| Publisher: |
HealthInsite Topic Page
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| Description: |
Links to information about directories and services related to health products, including therapeutic goods and devices, equipment and supplies.
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| Date: |
Jun 2008
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| Title: |
Advertising approval application forms
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Nov 2007
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| Title: |
Transmissible Spongiform Encephalopathies (TSEs) questionnaire for sponsors
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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)'.
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| Date: |
Dec 2004
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| Title: |
Access to unapproved therapeutic goods - Special access scheme
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Oct 2004
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| Title: |
Access to unapproved therapeutic goods - clinical trials
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
These documents describe the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
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| Date: |
Oct 2004
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| Title: |
Request form for GMP or Quality Systems certificates
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Aug 2004
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| Title: |
Literature based submissions - points to consider
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Apr 2003
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| Title: |
GMP audit of overseas manufacturer - TGA application form
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
May 2001
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| Results 1 to 14 displayed. |
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