Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:9_5
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 9 cl 5
Character Range: 254107–255145

5  After subsection 25AA(1A)
Insert:
 (1B) If:
 (a) there is medicine included in the Register in relation to a person and there is no product information approved under this section in relation to the medicine; and
 (b) the medicine becomes restricted medicine;
the Secretary may, by written notice given to the person, require the person to:
 (c) give the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and
 (d) give the Secretary that product information within the period specified in the notice (which must be at least 30 days after the notice is given).
 (1C) If the person complies with subsection (1B), the Secretary must approve product information in relation to the medicine that reflects the basis on which the medicine is registered at the time of the approval. The Secretary must, by written notice given to the person, set out the product information so approved.
Note: Subsection (4) deals with variation of the product information.