Application For Certificate For Exporter Of Medicinal Product / Certificate For Exporter Of Chinese Proprietary Medicine
Regulatory Guidelines and Standards
The Certificate for Exporter of Medicinal Product (or more commonly known as Certificate of Pharmaceutical Product, CPP) issued in the format as recommend by the WHO is a document that is internationally recognized by national drug regulatory authorities for establishing the status of medicinal product under a national drug product licensing system. The medicinal product has to be produced under a comprehensive system of quality assurance, conforming to GMP standards as mandated by WHO.
The certificate 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 certificate can be issued for medicinal products controlled under the Medicines Act of Singapore as well as those that are exempted from licensing control. The certificate will be prepared in English and transmitted to the requesting authority through the applicant. The applicant will be responsible for providing a notarized 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 certificate will normally expire 24 months or 6 months from the date of issuance for licensed medicinal 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.
A Certificate for Exporter of Chinese Proprietary Medicine (or a Free Sale Certificate), which serves a similar purpose as the Certificate for Exporter of Medicinal Product, will be issued for a CPM 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.