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This application is a service of the Singapore Government.

Health Sciences Authority

Therapeutic Products

Manufacturer's Licence for Therapeutic Product

Regulatory Guidelines and Standards

All therapeutic products are regulated under the Health Products Act and its subsidiary legislations. Under the Health Products Act, all local manufacturing facilities engaged in the manufacture or assembly of therapeutic products must be licensed with Health Sciences Authority. Thus, no person shall manufacture or assemble any therapeutic product except in accordance with a licence grant for the specific purposes (referred to in the Health Products Act as a Manufacturer's Licence).

Applicants for a Manufacturer's Licence should submit an online application form via PRISM.

The GMP Unit of the Audit & Licensing Division (ALD) in Health Sciences Authority is responsible for the audit and licensing of therapeutic product manufacturers and assemblers in accordance with current international Good Manufacturing Practice (GMP) standard. A Manufacturer's Licence would only be granted when the manufacturing facilities has been assessed, audited and found to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products. The holder of a Manufacturer's Licence shall comply with all the provisions and licensing conditions for a manufacturer's licence under the Health Products Act.

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products

For more information on the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products, please click here

The PIC/S Guide to GMP for Medicinal Products Part I can be downloaded from here.

The PIC/S Guide to GMP for Medicinal Products Annexes can be downloaded from here.