Certificate of a Pharmaceutical Product

Apply for a Certificate of a Pharmaceutical Product.

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.

The certificate will expire 6 or 24 months from the date of issuance, depending on the product type. It cannot be renewed or reissued, and upon expiry, a new application must be submitted, if required.

Registered therapeutic product

You will need to submit the following documents:

Unregistered therapeutic product made for export only or under product evaluation

You will need to submit the following documents:

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).

Refer to our guide on New Application for Certificate of a Pharmaceutical Product926 KB for more details when making an application.'
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