Medicines, Poisons and Therapeutic Goods Act 2012
157CHO may vary conditions to achieve object of Act
Start here
Get a plain-English read of 157
Turn the raw legal text into a practical explanation grounded in Medicines, Poisons and Therapeutic Goods Act 2012.
157 CHO may vary conditions to achieve object of Act (1) The CHO may decide to vary the conditions of an authority if: (a) the CHO becomes aware of information that, if it had been known when the authority was issued or renewed, the CHO would have imposed conditions or different conditions on the authority; and (b) the CHO is satisfied it is necessary to achieve the objects of this Act. (2) Before deciding to vary the conditions, the CHO must: (a) give written notice to the holder of the authority: (i) of the particulars of the proposed variation; and (ii) that the holder may make written submissions to the CHO about the proposed variation within a reasonable period of at least 21 days stated in the notice; and (b) have regard to written submissions made to the CHO by the holder before the stated day; and (c) for a Schedule 8 authorisation issued without considering the Committee's advice – consider the Committee's advice given under section 133. (3) If the CHO decides to vary the conditions of the authority, the CHO must immediately give the holder an information notice for the
Division 3 Variation of conditions of authority on application by holder Medicines, Poisons and Therapeutic Goods Act 2012 90 Division 3 Variation of conditions of authority on application by holder 158 Application (1) The holder of an authority may apply to the CHO for the variation of the conditions of the authority. (2) The application must be: (a) in the approved form; and (b) accompanied by sufficient documents and information to enable the CHO to decide the application, including the documents and information stated in the approved form.