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 medicated oils and balms (MOB). The MOB 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.

Documents required

You will need to submit the following documents:

•  The Schedule (Unregistered products)92 KB
• Other supporting documents, if applicable.

Fee

The application fee is $106.

Turn-around-time

Turn-around-time is 10 working days from the date of application.

Note: Turn-around-time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

• GIRO (application form129 KB)
• eNETS

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).