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Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018
5Conditions of inclusion in Register—variations
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5 Conditions of inclusion in Register—variations
For the purposes of paragraph 32EC(2)(e), a person in relation to whom a biological is included in the Register must not implement a variation to, or in relation to, the biological before the Secretary approves the variation by varying the entry in the Register that relates to the biological under section 9D of the Act.