On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in requesting product certificates, known as Certificates of Pharmaceutical Product (CPP), and is intended to guide through the process of completing the request form.
Certificates of Pharmaceutical Product (CPP): CPP is a document issued by regulatory authorities, such as Swissmedic, certifying the quality, safety, and efficacy of a pharmaceutical product. CPP facilitates the importation of pharmaceutical products into countries that require evidence of regulatory approval.
The CPP is an official confirmation for foreign regulatory bodies that describes the status of the companies concerned and the authorised medicinal product in a structured form. These certificates are essential for demonstrating compliance with regulatory requirements when exporting pharmaceutical products.
A CPP can only be requested by authorisation holders or their authorised representatives, and it applies to both Swiss and export licences. Medicinal products manufactured in Switzerland, but not authorised in Switzerland cannot be covered by a CPP. Only information that has been confirmed by Swissmedic and communicated to the authorisation holder is provided by the applicant.
As soon as Swissmedic receives the request, it generates the CPP on the basis of the information in the request. However, Swissmedic reserves the right to check on a random basis that the information in the request matches the information in the authorisation dossier in Swissmedic's possession.
The form for requesting CPP and the guidance document for completing the form is available on the Swissmedic website at www.swissmedic.ch. The form is a file in Excel format with the extension xlsx. The person placing the order must ensure that the currently valid published form is used.
The information in the request form is processed electronically at Swissmedic and converted directly into the CPP format defined by the WHO. Since the process is largely automated, it is particularly important that the information in the form is correct in order to avoid errors in the CPP.
Click this LINK to know more about the basic rules, and the steps in completing request forms.
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