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This document applies to licence holders who are responsible for introducing registered western medicinal products into Singapore. It provides guidance to licence holders on the submission of relevant safety information relating to registered western medicinal products to the Vigilance Branch. It addresses the types of documents to be submitted, the timelines and the requirements for reporting drug safety information.

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If you need further information, please contact:
Vigilance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
#11-03 Helios
Singapore 138667
Tel: (65) 6866 3538
Fax: (65) 6478 9069
Email: HSA_safety@hsa.gov.sg