Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021
sec.18Manufacturing supervisors
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sec.18 Manufacturing supervisors
The holder of a manufacturing licence must appoint an appropriately qualified person to supervise manufacturing under the licence. The holder must take all reasonable steps to ensure— the person mentioned in subsection (1) satisfies, and continues to satisfy, the competency requirements stated in the competency standard that relate to the supervision of manufacturing for the type of licence held; and the manufacture of a regulated poison under the licence is carried out under the supervision of the person. In this section— competency standard means the departmental standard called ‘Competency requirements for authority holders dealing with poisons’. (sec.18-ssec.1) The holder of a manufacturing licence must appoint an appropriately qualified person to supervise manufacturing under the licence. (sec.18-ssec.2) The holder must take all reasonable steps to ensure— the person mentioned in subsection (1) satisfies, and continues to satisfy, the competency requirements stated in the competency standard that relate to the supervision of manufacturing for the type of licence held; and the manufacture of a regulated poison under the licence is carried out under the supervision of the person. (sec.18-ssec.3) In this section— competency standard means the departmental standard called ‘Competency requirements for authority holders dealing with poisons’.
- (a) the person mentioned in subsection (1) satisfies, and continues to satisfy, the competency requirements stated in the competency standard that relate to the supervision of manufacturing for the type of licence held; and
- (b) the manufacture of a regulated poison under the licence is carried out under the supervision of the person.