What is TGA eBS?
Andrew Vasquez What is TGA eBS?
TGA eBusiness Services is an online portal that provides separate functions for consumers, health professionals and industry. The eBS hosts the Australian Register of Therapeutic Goods (ARTG), and provides publicly available information about current medicines and medical devices.
What does TGA stand for?
Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health , and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
What is a TGA certificate?
The licensing/certification process. Australian medicines manufacturers are required to obtain a licence to manufacture therapeutic goods (sometimes referred to as GMP licence). Overseas medicines manufacturers, where GMP clearance is based on a TGA inspection, obtain GMP Certification when passing a TGA inspection.
What is TGA compliance?
Regulatory compliance framework. The TGA safeguards the health of the Australian community through effective and timely regulation of therapeutic goods. The TGA’s compliance functions support the broader regulatory objectives, including consumer protection, and enable a fair market for industry.
Is the TGA a corporation?
The Therapeutic Goods Administration (TGA) is part of the Health Products Regulation Group (HPRG) within the Department of Health and is committed to delivering a world class, efficient and timely regulatory system for therapeutic goods.
What is product information TGA?
Product information (PI) is a term used to describe the technical information approved by the TGA and intended for distribution to health professionals. It may be distributed via publications such as Medical Information Management System (MIMS).
What does Susmp stand for?
Standard for the Uniform Scheduling of Medicines and Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA). Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
What is the role of the TGA?
The TGA is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. What are ‘therapeutic goods’? Many of us use medicines or medical devices in our daily lives.
How do I get a TGA certificate?
Applying for a licence or GMP certification
- Making a statutory declaration.
- Drafting and submitting your application. Submitting a TGA manufacturing licence application. Submitting a GMP certification application.
- Paying the application fee.
- Determining your application’s effectiveness.
Do I need to register with TGA?
Therapeutic goods must be entered in the Australian Register of Therapeutic Goods(ARTG) before they can be lawfully supplied in, imported into, or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.
How does the TGA work?
The TGA approves and regulates products based on an assessment of risks against benefits. All therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk.
Is TGA independent?
As part of the Department of Health, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics….Therapeutic Goods Administration.
| Agency overview | |
|---|---|
| Formed | 1989 |
| Jurisdiction | Australian Government |
| Employees | 750 (2016) |
| Annual budget | A$170 million (2020–21) |
What does TGA business services do?
TGA Business Services TGA Business Services establishes a base for electronic commerce, electronic lodgement of data packages in support of applications for entry of products onto the Australian Register of Therapeutic Goods and enables online client access to legally appropriate information.
When are the planned maintenance dates for the TGA?
19/08/2021: Planned Maintenance Friday 27 August 2021 10:50pm to 11:20pm. 28/08/2020: Upload of PI and CMI documents for non-prescription medicines and biologicals to TGA website
How do I contact EBS support in Australia?
Therapeutic Goods Administration | Copyright | Privacy | Disclaimer | Security | Browser Support | | For further information contact the eBS Help Lines, [email protected]
