Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:1_6
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 1 cl 6
Character Range: 6573–8546

6  After subsection 9D(1)
Insert:
 (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).