Document ID: chunk:federal_register_of_legislation:C2024C00632:section:9d:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 9D (pt 1/4)
Character Range: 84001–86673

9D  Variation of entries in Register
 (1) The Secretary may:
 (a) following a request by a person in relation to whom therapeutic goods are entered on the Register; or
 (b) on the Secretary's own initiative;
vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect.
 (1A) If:
 (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and
 (b) it appears to the Secretary that the quality, safety or efficacy of the medicine is unacceptable in relation to a class of persons;
the Secretary may, on the Secretary's own initiative, vary the entry in the Register in relation to the medicine:
 (c) to reduce the class of persons for whom the medicine is suitable or to change the directions for use; or
 (d) to add a warning, or precaution, that does not include any comparison of the medicine with any other medicine by reference to quality, safety or efficacy.
Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4).
 (1B) If:
 (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and
 (b) the Secretary makes a decision under subsection 29(9) to extend the provisional registration period for the medicine;
the Secretary may, on the Secretary's own initiative, vary the entry in the Register in relation to the medicine to reduce the class of persons for whom the medicine is suitable or to change the directions for use.
Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4).
 (1C) If the Secretary proposes to make a variation under subsection (1A) or (1B), the Secretary must:
 (a) give the person in relation to whom the medicine is registered written notice of the proposed variation and of the reasons for the proposed variation; and
 (b) give the person a reasonable opportunity to make a submission to the Secretary in relation to the proposed variation; and
 (c) if the person makes a submission in accordance with paragraph (b)—take the submission into account before making a decision whether or not to make the variation.
 (1D) Subsections (1A) and (1B) apply despite subsection 16(1).
 (2) If:
 (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and
 (b) the only effect of the variation would be:
 (i) to reduce the class of persons for whom the goods are suitable; or
 (ii) to add a warning, or precaution, that does not include any comparison of