(5) The Director may give or not give the direction—
- (a) after considering any written representation made to the Director pursuant to the notice in subsection (4); or
- (b) after the time specified in the notice under subsection (4)(b), where no representation is so made or any written representation made is subsequently withdrawn.
(6) The Director must serve on the licensee concerned a notice of the Director’s decision under subsection (5).
(7) A direction given under subsection (1) takes effect from the date on which the notice under subsection (6) is given, or on such other date as the notice may specify.
(8) Every licensee must comply with every direction given under this section to the licensee as soon as it takes effect.
(9) A licensee that fails to comply with any direction given to that licensee under subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 12 months or to both and, in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.
Directions relating to quality assurance committees, etc.
40.—(1) The Director may give a direction to a section 25 licensee to do anything required in this section, within the time and in the manner that the direction may specify.
(2) A direction given under subsection (1) may relate to a quality assurance committee appointed by a section 25 licensee, and require the section 25 licensee to do any of the following:
- (a) to require the quality assurance committee to conduct a further evaluation of any prescribed adverse event identified by that committee;
