Singapore legislation
Regulation 26
Regulation 26
Investigational medicinal product and auxiliary medicinal product labelling
Subregulation 1
The sponsor must ensure that all investigational medicinal products and auxiliary medicinal products used in the clinical trial are labelled in accordance with the requirements set out in the Second Schedule.
Subregulation 2
The sponsor must ensure the ready accessibility of the key to any code used in the labelling under paragraph 1(2) or 2(b) of the Second Schedule of an investigational medicinal product in a blinded clinical trial, so as to enable the rapid identification of the product in the case of an emergency.
Subregulation 3
The sponsor must ensure that all investigational medicinal products and auxiliary medicinal products used in the clinical trial are stored in such manner as to be easily identifiable.
Subregulation 4
A person must not use any investigational medicinal product or auxiliary medicinal product in a clinical trial if the container in which the product is stored is not labelled in accordance with the requirements set out in the Second Schedule.