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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