Regulation 13

For the purpose of section 18 of the Act, a person must not supply any clinical research material for the purpose of being used in any regulated clinical trial, unless it is labelled in accordance with the Second Schedule to the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016); except that paragraph 1(1)(d), (2)(a) to (d) and (g), (3)(a) to (d), (g) and (j) and (4)(a), (b), (e) and (h) of that Schedule does not apply if the supply is by wholesale.

For the purpose of section 18 of the Act, a person must not supply any other clinical research material unless it is labelled in accordance with the requirements set out in the Third Schedule.