Certificate of a Pharmaceutical Product

Overview

A Certificate of Pharmaceutical Product (CPP) is a certificate issued in the format as recommended by the World Health Organisation (WHO). It is a document that is internationally recognized by national drug regulatory authorities for establishing the status of a pharmaceutical product under a national product licensing system.

A CPP may be issued for an active ingredient manufactured in Singapore. The active ingredient must be produced under the required Good Manufacturing Practice (GMP) standards.

The CPP is specific for one active ingredient as well as one country of import. Among other information, the certificate includes the details of the manufacturing site.

Documents required

You will need to submit the following documents:

•  The schedule (unregistered products)92 KB
• Other supporting documents, if applicable.

Fees and turnaround time

Refer to active ingredient licence and certificate fees and turnaround time for more information.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

• CRIS company account
• Corppass or HSA PIN

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).