Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 4 · Supplies of Clinical Research Materials
11. Supply to subject of prescription‑only or pharmacy‑only medicine
Feedback & supportThis regulation applies to a supply of any clinical research material that is prescription‑only medicine or pharmacy‑only medicine to a subject in any clinical research that is not a regulated clinical trial.
A person must not make the supply unless —
the person is specified in the first column of Part 1 of the Second Schedule; and
the person makes the supply in the circumstances specified against the person in the second column of Part 1 of the Second Schedule.
Subregulation 1
This regulation applies to a supply of any clinical research material that is prescription‑only medicine or pharmacy‑only medicine to a subject in any clinical research that is not a regulated clinical trial.
Subregulation 2
A person must not make the supply unless —
the person is specified in the first column of Part 1 of the Second Schedule; and
the person makes the supply in the circumstances specified against the person in the second column of Part 1 of the Second Schedule.