Singapore legislation
Regulation 13
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 13
Recall of clinical research material
Subregulation 1
Where any person intends to recall any clinical research material which the person manufactured, assembled, imported or supplied under regulation 3, the person must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of the intended recall and the reasons for the 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 notice in writing 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.