Commonwealth Consolidated Regulations

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Use of goods for experimental purposes--specified conditions

    For subsections   19(4A) and 32CL(1) of the Act, the following conditions are specified:

  (a)   the use of therapeutic goods in a clinical trial must be in accordance with the Practice Guideline;

  (b)   the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;

  (c)   the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;

  (d)   the use must cease if the ethics committee mentioned in paragraph   (b) informs the principal investigator that the use is inconsistent with:

  (i)   the protocol mentioned in paragraph   (b); or

  (ii)   any condition subject to which approval for the use was given.

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