Unacceptable presentation of therapeutic goods—prescribed class of medicine
3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine
For paragraph 3(5)(ca) of the Act, a prescribed class of medicine is medicine for supply in Australia that is not:
a product of a kind mentioned in Part 1 of Schedule 10; or
a medicine that satisfies the following requirements:
the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;
the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);
the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii); or
a medicine that satisfies the following requirements:
the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act;
if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or
a medicine that satisfies the following requirements:
the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act;
if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.
This Act’s bill:Explanatory statement
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