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This application is a service of the Singapore Government.

Health Sciences Authority

Guidance Documents

Manufacturer's Licence for Therapeutic Product

Applicant for a manufacturer's licence of therapeutic products should submit a Site Master File as an attachment together with the required information via online services (PRISM). For information on the preparation of a site master file, please refer to Guidance Notes for Pharmaceutical Manufacturers on Preparation of a Site Master File. Applicant for a manufacturer's licence of therapeutic products should familiarize themselves with the guidance documents provided below.