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Testing of biological medicines
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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