Health Products (Clinical Trials) Regulations 2016 · As enacted · Part 2 · Clinical Trials of Therapeutic Products or Applicable Ctgt Products
26. Investigational product and auxiliary product labelling
Feedback & supportLast amended by an amending law of 2021.
The sponsor must ensure that all investigational products and auxiliary products used in the clinical trial are labelled in accordance with the requirements set out in the Second Schedule.
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 product in a blinded clinical trial, so as to enable the rapid identification of the product in the case of an emergency.
The sponsor must ensure that all investigational products and auxiliary products used in the clinical trial are stored in such manner as to be easily identifiable. (4) A person must not use any investigational product or auxiliary 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.
Subregulation 1
The sponsor must ensure that all investigational products and auxiliary 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 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 products and auxiliary 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 product or auxiliary 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.