You’re responsible for keeping your medicine safe and complying with relevant regulations after it’s approved and supplied in Australia.
You must:
maintain your product’s inclusion in the Australian Register of Therapeutic Goods (if required)
apply for variations if required if there are any changes to your product
pay ongoing regulatory charges
monitor safety
report product issues.
We also monitor medicines to protect public health and work with you to address any safety concerns.
This stage helps ensure your medicine continues to meet safety, quality and compliance requirements while it's on the market.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
-
User guideThis user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
-
PageSee how to use the black triangle symbol and text in our templates with correct format and wording.
-
PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
-
FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
-
GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
-
User guideElectronic data interchange for ICSR submission using the E2B R2 format
-
PageInformation for sponsors and manufacturers explaining what to do if there is a medicine shortage.
-
FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
-
PageAn internationally used set of terms relating to medical conditions, medicines and medical devices.
-
PageFind out how we monitor medicines safety, including the systems we use to track and review safety, and guidelines for specific types of medicines.
-
PageHow we model supply and demand data to manage the most serious national medicine shortages.
-
PageYou need to notify us if your reportable medicine is in shortage or is being discontinued.
-
User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
-
PageInformation about how the safety of medicines is monitored for sponsors and manufacturers.
-
PageInformation on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
-
GuidanceAustralian recommendations and requirements
-
-
PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
-
PageRecall coordinators play an important part in the market action process.
-
PageReport counterfeit products, suspicious or illegal activity, or make a complaint about non-compliant advertising.
-
FormsUse this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
-
PageUnderstand what information you must report about current or anticipated shortages of reportable medicines.
-
PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
-
ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
-
PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
-
PageSummarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
-
PageInformation on the TGA Laboratories testing program for therapeutic goods.
-
PageThe Black Triangle goes on medicine information documents for new prescription medicines in Australia. It is a reminder to people to report any adverse events related to these new medicines.
-
GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
Compliance
Learn how we ensure compliance, including post-market reviews.
-
PageKnow the ways we respond to breaches such as warnings, fines and legal action.
-
PageFind out how we approach and manage compliance with therapeutic goods regulation in Australia.
-
PageRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.
-
PageInformation about therapeutic goods cancelled at the request of the sponsor.
-
PageInformation about how the TGA uses and calculates the value of infringement notices
-
GuidanceGuidance for making an offer of enforceable undertaking to us.
-
-
GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
-
PageWatch this video for an overview of the TGA compliance framework.
Product types