Certificate of a Pharmaceutical Product & Certificate for Exporter of Chinese Proprietary Medicine
Regulatory Guidelines and Standards
Certificate of a Pharmaceutical Product
The Certificate of a Pharmaceutical Product (CPP) issued in the format as recommended by the WHO is a document that is internationally recognised by national drug regulatory authorities for establishing the status of pharmaceutical product under a national drug product licensing system. The pharmaceutical product has to be produced under a comprehensive system of quality assurance, conforming to 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 specifies whether or not a product is sold in Singapore. Where a product is limited to export, a standard comment would be included in the certificate to define the reason. Product details, such as the formulation, are also provided in the certificate.
The CPP can be issued for therapeutic products controlled under the Health Products Act of Singapore as well as medicinal products that are exempted from licensing control under the Medicines Act. The certificate will be prepared in English and transmitted to the requesting authority through the applicant. The applicant will be responsible for providing a notarised translation that may be required by the requesting authority. The competent authority in the requesting country could request a copy of the certificate directly from HSA for the purpose of verifying its authenticity.
The CPP will normally expire 24 months or 6 months from the date of its issuance for registered therapeutic products and medicinal products exempted from licensing control respectively. Upon expiry, a new application must be submitted. The certificate cannot be renewed or re-issued.
Certificate for Exporter of Chinese Proprietary Medicine
A Certificate for Exporter of Chinese Proprietary Medicine (or a Free Sale Certificate), which serves a similar purpose as the Certificate of a Pharmaceutical Product (CPP), will be issued for a Chinese Proprietary Medicine which has been approved by HSA to be distributed and sold in Singapore. The certificate is specific for one product and limited to inclusion of up to 5 importing countries. The certificate will normally expire 24 months from the date of issuance.
New Information Related to Implementation of the Health Products (Therapeutic Products) Regulations 2016 (effective from 1 November 2016)
The Certificate of a Pharmaceutical Product (CPP) for therapeutic producs will be issued under the Health Products (Therapeutic Products) Regulations 2016. There will not be any change to the regulatory requirements in the application and issuance of the CPP.
The Certificate for Exporter of Chinese Proprietary Medicine (or a Free Sale Certificate) will continue to be issued under the Medicines Act.