Recall coordinators for therapeutic goods From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Recall coordinators play an important part in the uniform recall procedure for therapeutic goods Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Infringement notices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ An infringement notice with a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Supply an unapproved therapeutic good (sponsors) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Should your product be in the ARTG From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Check if your product should be on the Australian Register of Therapeutic Goods (ARTG) Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Advertising: News and reports From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Announcements regarding therapeutic goods advertising and other related activities. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Varying entries in the ARTG: medical devices and IVDs From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
MMDR program achievements From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have delivered a raft of reforms, in addition to maintaining core business activities that ensure the high quality regulation of therapeutic goods in Australia. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Report a perceived breach or questionable practices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure From Therapeutic Goods Administration (TGA) ๐ฆ๐บ How the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA structure From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Therapeutic Goods Administration is part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods (Medical DevicesโInformation that Must Accompany Application for Inclusion) Determination 2018 From Office of Parliamentary Council Australia ๐ฆ๐บ Document F2018L01410. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Therapeutic Goods (Medical Devices) Regulations 2002 From Office of Parliamentary Council Australia ๐ฆ๐บ Document F2002B00237. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 12, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Therapeutic Goods (Medical DevicesโInformation that Must Accompany Application for Inclusion) Amendment Determination 2024 From Office of Parliamentary Council Australia ๐ฆ๐บ Document F2024L00760. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 25, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Regulatory obligation for exempt medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Exempt therapeutic goods do not need to be included in the ARTG. They do still need to comply with other regulatory requirements. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
International scientific guideline: Questions and Answers: Positions on specific questions addressed to the pharmacokinetics working party From Therapeutic Goods Administration (TGA) ๐ฆ๐บ EMA/618604/2008 adopted by the Therapeutic Goods Administration (TGA) Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
International scientific guideline: ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tests for specified micro-organisms From Therapeutic Goods Administration (TGA) ๐ฆ๐บ EMA/CHMP/ICH/308817/2008 adopted by the Therapeutic Goods Administration (TGA) Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (March 2023) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (the Amendment Act) was passed by both Houses of Parliament on 9 March 2023 Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Restricted and prohibited representations in advertising From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Understand the limitations that apply to the use of certain representations when advertising therapeutic goods. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Obtain and maintain regulatory evidence From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Understand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Links to international agencies & organisations From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Links to websites of international agencies and organisations related to therapeutic goods regulation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites