Overview
The Certificate of Pharmaceutical Product (CPP), issued in the format as recommended by the World Health Organisation (WHO), is a document that is internationally recognised by national drug regulatory authorities for establishing the status of a pharmaceutical product under a national drug product licensing system.
In Singapore, a CPP can be issued for registered therapeutic products or unregistered therapeutic product made for export only or under product evaluation. The therapeutic product must be produced under a comprehensive system of quality assurance, conforming to Good Manufacturing Practice (GMP) standards as mandated by WHO.
The CPP is specific for one product as well as one country of import. Among other information, the certificate includes:
- Information on whether or not a product is sold in Singapore.
- Details of the manufacturing site.
- Product details, such as the formulation.
Fees and turnaround time
Refer to therapeutic product 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:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).