You are here
TGA Internet site archive
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
Testing of biological medicines
Applicable to biological medicines, excluding vaccines, anti-venoms and toxins
19 July 2019
Legislative basis
Evaluation and registration of all new biological medicines:
- section 25 of the Therapeutic Goods Act 1989 (the Act)
- with reference to subregulations 16C and 16D of the Therapeutic Goods Regulations 1990 (the Regulations)
Variation of the entry of the ARTG:
- section 9D of the Act
Conditions of registration:
- section 28 of the Act
Testing of therapeutic goods:
- Part 5 of Therapeutic Goods Regulations 1990