Australian Register of Therapeutic Goods ARTG and the TGA eBS

What is the Australian Register of Therapeutic Goods or the ARTG?TGA eBS and ARTG

A therapeutic good(s), such as Medical Device, IVD  or Medicine, must be “entered in” or “included in” the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia. The therapeutic goods must be manufactured in a manner which complies with GMP or ISO standards, such as ISO 13485. The information held on the ARTG includes information on the Manufacturer, the Australian sponsor as well as the Product name.

The ARTG is searchable by the Australian public and international readers by following the link.

The search will return the Product Name, the sponsor name, the therapeutic good type, the start date and a Public ARTG summary.

The record is produced from the interface know as the TGA eBS, short for the Therapeutic Goods Administration (TGA) and the Electronic Business Services, the TGA eBS is the portal where a sponsor lodges relevant information relating to the product they intend to sell in Australian.

 More about the TGA eBS?

The electronic Business Services, (eBS or TGA eBS) is an electronic lodgement portal of product and manufacturing information to support an applications for entry of products onto the Australian Register of Therapeutic Goods (ARTG) and enables industry and the public to access to legally appropriate information.

The final Australia Register of Therapeutic Goods, is a searchable database of medicines and devices that may be lawfully supplied in Australian, it includes Consumer Product Information, Manufacturers and ingredients. The ingredients may be proprietary and confidential, this proprietary information is protected by the TGA.

PharmOut GMP and Regulatory Services

As an Australian Pharmaceutical Consulting company, PharmOut frequently assists manufacturers to obtain or keep a manufacturing licence, as well as navigating through the regulatory minefield of listing or registering a medical device or new medicine.

PharmOut are registered officially as Australian Therapeutic Goods Consultants (ATGC). The Association of Therapeutic Goods Consultants is the peak body for regulatory and GMP consultants in Australia and New Zealand, providing technical advice for sponsors and manufacturers of medicines and medical devices for human use.

Read more about PharmOut Architectural, Engineering, Validation, GMP and regulatory services here.

Looking to access the Therapeutic Goods Administration electronic Business Services databases?

You do this from the links below –

  • Ingredients (link is external)
    This Ingredients Database portal provides the list of approved names for chemical, biological and herbal ingredients that may be used in TGA-regulated therapeutic goods.

 

For more information read our blog post: Regulation of Advertising of Therapeutic Goods.