Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 32CC

Conditions of exemptions

    An exemption under section   32CB is subject to conditions specified in the exemption about any of the following:

  (a)   the quantity of biologicals that are exempt;

  (b)   the source of those biologicals;

  (c)   the persons or class of persons who may import, export, manufacture or supply those biologicals;

  (d)   the supply of those biologicals (including the persons or class of persons to whom biologicals may be supplied for use and the circumstances under which a stockpile of biologicals may be supplied for use);

  (e)   the storage and security of those biologicals;

  (f)   the keeping and disclosure of, and access to, records about those biologicals;

  (g)   the disposal of those biologicals;

  (h)   the manner in which any of those biologicals is to be dealt with if a condition of the exemption is breached;

  (i)   any other matters that the Minister thinks appropriate.

Whether or not biologicals are exempt under section   32CB is not affected by whether or not there is a breach of a condition under this section in relation to those biologicals.

Note 1:   There are criminal offences and civil penalties related to the breach of a condition of an exemption: see sections   32CH and 32CI.

Note 2:   Section   32CD deals with variation and revocation of the conditions.


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