Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT ACT 1991 No. 204 of 1991 - SECT 14

14. Section 32 of the Principal Act is amended by adding at the end the
following subsections:

"(4) Where:

   (a)  the person in relation to whom therapeutic goods are registered or
        listed has asked the Secretary to vary product information included in
        the entry in the Register that relates to the goods; and

   (b)  the only effect of the variation would be to reduce the class of
        persons for whom the goods are suitable or to add a warning or
        precaution, being a warning or precaution that does not include any
        comparison of the goods with any other therapeutic goods by reference
        to quality, safety or efficacy; the Secretary must vary the entry in
        accordance with the request.

"(5) Where:

   (a)  the person in relation to whom therapeutic goods are registered or
        listed has asked the Secretary to vary information, other than product
        information, included in the entry in the Register that relates to the
        goods; and

   (b)  the Secretary is satisfied that the variation requested does not
        indicate any reduction in the quality, safety or efficacy of the goods
        for the purposes for which they are to be used; the Secretary may vary
        the entry in accordance with the request.

"(6) In this section, "product information", in relation to therapeutic goods,
means information relating to the safe and effective use of the goods,
including information regarding the usefulness and limitations of the goods.".