You are here Home Guidance and resources Find TGA forms, guidance, databases, alerts and publications here. Listen Print Share LinkedIn Twitter Facebook Email Loading... Frequently searched in Resources Australian Register of Therapeutic Goods (ARTG) Search our database of therapeutic goods that can be supplied in Australia. Safety alerts Stay up to date on the latest safety alerts for health products with possible risks. Medicine shortage alerts Find alerts about a medicine shortage. Resources and publications Resources Search our resources for guidance, checklists, international scientific guidelines, compositional guidelines and forms. Guidance Therapeutic Goods Administration (TGA) guidance for industry. Forms Therapeutic Goods Administration (TGA) forms. Checklists Therapeutic Goods Administration (TGA) checklists. Publications Find corporate publications, reports, statements, labelling exemptions and stakeholder surveys. Application and enquiry portals TGA Business Services (TBS) Set up your TBS account and manage applications and ARTG entries - information for sponsors and manufacturers. Online payment portal Industry portal - Access the online payment portal. Apply to use a restricted representation in advertising Portal for advertisers applying to use a restricted representation. Make an advertising enquiry Industry portal. Ask a question about advertising therapeutic goods. Reference information for applications Ingredients search Search the list of ingredients approved for use in therapeutic goods. Proprietary Ingredients search Search for proprietary ingredient names and their ID numbers. Indications for Listed medicines Search the table of permitted indications for listed medicines. Code tables Search the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance. Australian manufacturer search A list of Australian manufacturers that hold a current TGA manufacturing licence. Conformity assessment certificate search Search the list of conformity assessment (CA) certificates issued by the TGA to manufacturers of medical devices. International scientific guidelines adopted in Australia International scientific guidelines adopted in Australia Acronyms, glossary and plant part taxonomy Acronyms and glossary terms Terms, definitions and acronyms used in Australian therapeutic goods regulation. Plant parts Approved terminology for herbal ingredient plant parts. Plant preparations Approved terminology for herbal ingredient plant preparations. Make a report Report an adverse event to a medicines or vaccine Online form for anyone to report an adverse event to a medicine or vaccine. Report a medicine or vaccine defect Use this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine. Report a medical device incident - for consumers and health professionals Consumers and health professionals can report an incident via our online forms. Report a medical device incident - for sponsors and manufacturers Industry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system. Report a perceived breach or questionable practices Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products. Report non-compliant advertising Use this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good. Safety and shortages Safety alerts Stay up to date on the latest safety alerts for health products with possible risks. Safety updates Read our articles for health professionals about health product safety. Product recalls Find information about a health product recall. System for Australian Recall Actions (SARA) Search for products that have been recalled. Medicine shortage alerts Find alerts about a medicine shortage. Medicine shortage reports database Search for medicines that are in low supply and information about alternative medicines. Section 19A approvals Search approvals to import and supply medicines not in the ARTG to address medicine shortages. Database of Adverse Event Notifications (DAEN) Provides information about adverse events and incidents related to therapeutic goods used in Australia. Database of Adverse Event Notifications (DAEN) - medicines Find information about adverse events related to medicines, vaccines and biological therapies used in Australia. Database of Adverse Event Notifications (DAEN) - medical devices Find information about adverse events related to medical devices used in Australia. Australian Register of Therapeutic Goods - cancellations and suspensions Australian Register of Therapeutic Goods (ARTG) Search our database of therapeutic goods that can be supplied in Australia. Cancellations by sponsors Search our database of cancellations of Australian Register of Therapeutic Goods (ARTG) entries requested by sponsors. Cancellations and suspensions Search our database of cancellations and suspensions from the ARTG. Cancellations for failure to pay annual charges Products cancelled from the Australian Register of Therapeutic Goods (ARTG) for unpaid fees. Face mask cancellations Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting from the TGA’s post-market review. Sponsors Search our Sponsor database to view the regulatory activities for each sponsor. COVID-19 product and reports COVID-19 test kits Tests approved by TGA for inclusion in the ARTG for legal supply in Australia. COVID-19 disinfectants Disinfectants that claim to be effective against the virus that causes COVID-19. COVID-19 ventilators A list of ventilators permitted for supply under COVID-19 Emergency Exemption between 8 April 2020 to 31 January 2021. Face mask cancellations Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting from the TGA’s post-market review. Face mask market actions Our database of outcomes of face mask reviews: defect alerts, product notifications, recalls, and no action taken. COVID-19 vaccine safety reports Read the latest update on the side effects reported for the COVID-19 vaccines. Face mask and respirator test reports Results of testing respirators and face masks against key performance criteria. Face mask non-compliance notices Masks in this database need variations to their ARTG entry, for corrections or to meet labelling requirements. Prescription medicine decisions Prescription medicines registrations Search our prescription medicines registrations including New Chemical Entities and New Biological Entities. Australian prescription medicine decision summaries Search our Australian prescription medicine decision summary database. Australian Public Assessment Reports (AusPAR) Search our AusPAR dataset. Prescription medicines under evaluation These applications for new medicines or new uses for existing medicines are under evaluation by the TGA. Prescription medicine determinations and designations Prescription medicines eligible for orphan drug status, or for registration via priority review or provisional approval. Regulatory notices
Australian Register of Therapeutic Goods (ARTG) Search our database of therapeutic goods that can be supplied in Australia.
Resources Search our resources for guidance, checklists, international scientific guidelines, compositional guidelines and forms.
Publications Find corporate publications, reports, statements, labelling exemptions and stakeholder surveys.
TGA Business Services (TBS) Set up your TBS account and manage applications and ARTG entries - information for sponsors and manufacturers.
Apply to use a restricted representation in advertising Portal for advertisers applying to use a restricted representation.
Code tables Search the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
Australian manufacturer search A list of Australian manufacturers that hold a current TGA manufacturing licence.
Conformity assessment certificate search Search the list of conformity assessment (CA) certificates issued by the TGA to manufacturers of medical devices.
International scientific guidelines adopted in Australia International scientific guidelines adopted in Australia
Acronyms and glossary terms Terms, definitions and acronyms used in Australian therapeutic goods regulation.
Report an adverse event to a medicines or vaccine Online form for anyone to report an adverse event to a medicine or vaccine.
Report a medicine or vaccine defect Use this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
Report a medical device incident - for consumers and health professionals Consumers and health professionals can report an incident via our online forms.
Report a medical device incident - for sponsors and manufacturers Industry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system.
Report a perceived breach or questionable practices Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products.
Report non-compliant advertising Use this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
Medicine shortage reports database Search for medicines that are in low supply and information about alternative medicines.
Section 19A approvals Search approvals to import and supply medicines not in the ARTG to address medicine shortages.
Database of Adverse Event Notifications (DAEN) Provides information about adverse events and incidents related to therapeutic goods used in Australia.
Database of Adverse Event Notifications (DAEN) - medicines Find information about adverse events related to medicines, vaccines and biological therapies used in Australia.
Database of Adverse Event Notifications (DAEN) - medical devices Find information about adverse events related to medical devices used in Australia.
Australian Register of Therapeutic Goods (ARTG) Search our database of therapeutic goods that can be supplied in Australia.
Cancellations by sponsors Search our database of cancellations of Australian Register of Therapeutic Goods (ARTG) entries requested by sponsors.
Cancellations for failure to pay annual charges Products cancelled from the Australian Register of Therapeutic Goods (ARTG) for unpaid fees.
Face mask cancellations Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting from the TGA’s post-market review.
COVID-19 disinfectants Disinfectants that claim to be effective against the virus that causes COVID-19.
COVID-19 ventilators A list of ventilators permitted for supply under COVID-19 Emergency Exemption between 8 April 2020 to 31 January 2021.
Face mask cancellations Search our database of face mask cancellations from the Australian Register of Therapeutic Goods, resulting from the TGA’s post-market review.
Face mask market actions Our database of outcomes of face mask reviews: defect alerts, product notifications, recalls, and no action taken.
COVID-19 vaccine safety reports Read the latest update on the side effects reported for the COVID-19 vaccines.
Face mask and respirator test reports Results of testing respirators and face masks against key performance criteria.
Face mask non-compliance notices Masks in this database need variations to their ARTG entry, for corrections or to meet labelling requirements.
Prescription medicines registrations Search our prescription medicines registrations including New Chemical Entities and New Biological Entities.
Australian prescription medicine decision summaries Search our Australian prescription medicine decision summary database.
Prescription medicines under evaluation These applications for new medicines or new uses for existing medicines are under evaluation by the TGA.
Prescription medicine determinations and designations Prescription medicines eligible for orphan drug status, or for registration via priority review or provisional approval.
