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Testing of biological medicines

Applicable to biological medicines, excluding vaccines, anti-venoms and toxins

19 July 2019

Book pagination

Legislative basis

Evaluation and registration of all new biological medicines:

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

Book pagination