Australian TGA consultants for Drug, Veterinary, Medical Device and IVD manufacturers
PharmOut employs a number of ex-Australian Therapeutic Goods Administration (TGA) inspectors as TGA consultants to ensure you get the best professional advice for your GMP and regulatory requirements. We can help you with obtaining regulatory approval from the TGA – certification or obtaining a manufacturing license.
If you are entering the Australian market for the first time, and have not yet found a Distributor, we can act as interim sponsors so you can obtain a TGA manufacturing certificate before listing or registering your drug or device on the Australian Register of Therapeutic Goods (ARTG).
Background to the TGA Regulations
The Australian Therapeutic Goods Administration (TGA) is Australia’s government agency in charge of medicinal products. This authority is given to them via the Commonwealth Therapeutic Goods Act.
The TGA regulates products used as or in therapeutic goods including:
- Over the counter (OTC) drugs
- Complementary medicines
- Biological products
- Topical products and devices
- Any goods claimed or implied to have therapeutic benefits
These products must be listed or registered with the TGA.
The Australian Register of Therapeutic Goods (ARTG) is a computer database of all approved medicines and medical devices in Australia. If a product is included, listed or registered (they are 3 different things) on ARTG, the TGA issues a unique identification number, which must be displayed on all product labelling.
PharmOut’s TGA Consultants frequently navigate through the applicable TGA regulations and requirements and submit applications for product listing or registration to the TGA on behalf of manufacturers.
Our TGA consultants have written several helpful White Papers that will help you understand the Australian regulatory requirements.