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Health Sciences Authority

Certificate of a Pharmaceutical Product and Statement of Licensing Status

Find out how to apply for a Certificate of Pharmaceutical Product and Statement of Licensing Status.

Last updated 24 March 2026

Certificate of a Pharmaceutical Product

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.

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:

Statement of Licensing Status

The Statement of Licensing Status (SLS) attests a specified therapeutic product has been registered for use in Singapore. It is usually intended to facilitate the screening and preparation of product information by importing agents when considering bids made in response to an international tender.

The SLS provides details pertaining to the therapeutic product such as:

  • Name

  • Dosage form

  • Composition

  • Product registration number

The SLS will be issued in the format as recommended by the World Health Organization.

Documents required

You will need the following supporting documents to complete your application:

  • Latest local sales invoice, if applicable.

  • Other supporting documents, if applicable.

Electronic Certificates

With effect from 25 March 2026, HSA will be issuing verifiable electronic certificates for exporters (including Certificate of a Pharmaceutical Product and Free Sale Certificate) using GovTech’s FileSG (opens in new tab) digital platform. FileSG will replace TrustDocs for issuance of verifiable electronic documents. There will not be any changes to the application process, regulatory requirements and application fees for these certificates. For further information, please refer to the HSA Frequently Asked Questions (opens in new tab) on Migration of TrustDocs to FileSG.

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 (opens in new tab) or call 6776 0168 (from 7.00 am to midnight daily).