Therapeutic Goods Administration (TGA)
Products that are used as or in therapeutic goods including pharmaceutical, OTC, complementary medicines, biological, topical products and devices, must be listed or registered with the Therapeutic Goods Administration (TGA), as required by the Commonwealth Therapeutic Goods Act. This also applies to goods that are marketed in such a manner that it either has or implies that it has therapeutic benefits or is a therapeutic good.
Upon listing or registration, the TGA includes the product on the Australian Register of Therapeutic Goods (ARTG), a computer database of all approved medicines and medical devices in Australia, and issues them with a unique identification number which must be displayed on all packaging and labelling.
The TGA ensures that in Australia, there is a standard of quality, and consumers are able to use the goods as directed and be satisfied that they are safe and will perform effectively.
ChemSkill's experienced TGA Consultants can inform you of the applicable TGA regulations and requirements based on your situation, providing relevant recommendations. Following this, ChemSkill is able to submit the application for product listing or registration to the TGA on your behalf.
ChemSkill can assist your company in a wide variety of TGA application types including:
- The preparation of applications and dossiers for listings and registrations
- Preparation of applications for medical devices.
- GMP Clearance for overseas manufacturers and arrangement of TGA auditing. Where required, ChemSkill can assist the manufacturer to meet TGA's GMP requirements, conduct preliminary GMP audits and to address any audit deficiencies.
- Assessment of product indications/claims and supporting scientific data.
- Review of labelling and packaging.
- Variations to registrations and listings.
- Export Certificates.
- Export only listings.
Contact A Therapeutic Goods Administration (TGA) Consultant
This form allows you to submit an online message to one of our TGA consultants.
Alternatively, you can email your enquiries to: firstname.lastname@example.org