(1) The Comptroller - General of Customs may, in writing, approve an entity's participation in a controlled trial if:
(a) either:
(i) the entity makes an application to participate in that trial in accordance with section 179F; or
(ii) the Comptroller - General of Customs invites, in writing, the entity to participate in that trial and the entity makes an election to participate in that trial in accordance with section 179G; and
(b) the Comptroller - General of Customs is satisfied that the entity meets the qualification criteria (if any) determined in an instrument under section 179K; and
(c) the Comptroller - General of Customs is satisfied that the entity meets the eligibility criteria (if any) specified in the rules in relation to that trial.
Note: Section 179F deals with making applications and section 179G deals with making elections.
(2) In deciding whether to approve an entity's participation in a controlled trial, the Comptroller - General of Customs must consider:
(a) any matter specified in the rules under paragraph 179L(3)(b) in relation to that trial; and
(b) any other matter that the Comptroller - General of Customs considers relevant.
Period for which approval is in force
(3) An approval under subsection (1) must specify the period for which it is in force.
Note: See section 179J for variation, suspension or revocation of an approval.
Copy of approval to be given to entity
(4) The Comptroller - General of Customs must give a copy of an approval under subsection (1) to the entity.
Notification of refusal to approve entity's participation in controlled trial
(5) If an entity makes an application or election to participate in a controlled trial and the Comptroller - General of Customs refuses to approve the entity's participation in the trial, the Comptroller - General of Customs must notify the entity of the refusal and of the reasons for the refusal.
Approval not a legislative instrument
(6) An approval under subsection (1) is not a legislative instrument.