Document ID: chunk:federal_register_of_legislation:F2025C00118:reg:11
Version: federal_register_of_legislation:F2025C00118
Segment Type: reg
Provision Reference: reg 11
Character Range: 15018–17171

11  Approval of premises
 (1) In the absence of exceptional circumstances, the Minister must not approve in principle premises unless the Minister is satisfied with a high level of confidence that:
 (a) the pathology services to be rendered at the premises will meet relevant standards for:
 (i) the kinds of services to be rendered; and
 (ii) the category; and
 (b) without limiting paragraph (a), the premises comply with the relevant requirements of:
 (i) the Act; and
 (ii) these Principles.
 (2) Subject to section 12, the Minister must only consider an application for approval of premises under section 23DN of the Act if the Minister is provided with an assessment report which is the most recent assessment report in relation to the premises.
 (3) In the absence of exceptional circumstances, the Minister must not approve in principle premises if within the 6 months preceding the application the last accreditation action in relation to the premises the subject of the application was:
 (a) a refusal by an independent body to grant an accreditation for pathology services rendered at the premises in relation to the kinds of services or to the category subject to the application before the Minister; or
 (b) a revocation by an independent body of an accreditation held for pathology services rendered at premises in relation to the kinds of services or to the category subject to the application before the Minister.
 (4) In the absence of exceptional circumstances, the Minister must not give an approval in principle unless the Minister is satisfied that the assessment report referred to in subsection (2) supports the approval of the premises as an accredited pathology laboratory for:
 (a) the kind of services; and
 (b) the category;
  covered by the application.
 (5) If premises are not approved in principle on account of the operation of subsection (4), and the applicant amends the application in relation to:
 (a) the kind of services; or
 (b) the category;
  covered by the application, the Minister may consider and deal with the amended application in accordance with these Principles as if it were an original application.