Singapore legislation
Regulation 20
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 20
Recall of clinical research material
Subregulation 1
For the purposes of section 44(1) of the Act, where any person intends to recall any clinical research material, the person must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.
Subregulation 2
The notice in paragraph (1) must be made in such form and manner as the Authority may require.
Subregulation 3
Where the Authority has been notified of the intended recall of any clinical research material under paragraph (1), the Authority may by written notice require the person to do either or both of the following:
investigate the matter occasioning the recall of the clinical research material and provide a report of the findings of the investigation;
take such other measures as the Authority thinks necessary.
Subregulation 4
A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.