Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical Product (CPP)". This document is essential for manufacturers and marketing authorization holders seeking to obtain CPPs for their products. Below is a summary of the key sections covered in the guidance document.
Certificate of Pharmaceutical Product (CPP): An official document issued by Swissmedic certifying the status of the pharmaceutical product and its compliance with the issuing country (Swiss) regulatory requirements.
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.
The objective of this guidance is to provide clear instructions for requesting a Certificate of Pharmaceutical Product (CPP) from Swissmedic. CPPs are required for various regulatory purposes, including the export of pharmaceutical products.
The purpose of this guidance is to provide you with instructions on completing the request form. In addition to comments provided for each section that does not explain itself, references to the relevant section of the WHO format for CPP are included in the attachments to this guideline in English, Spanish and French.
Swissmedic can only issue CPPs to authorised holders or their representatives. This applies to both Swiss market authorizations and export licences. CPPs cannot be issued for medicinal products that are manufactured but not authorised in Switzerland.
Swissmedic creates the required CPP based on the information provided in the request. However, Swissmedic may randomly verify that the information matches the authorization dossier it has on hand. Should discrepancies be discovered, the CPP request will be denied, and the company will have to update the authorization status of the medicinal product by submitting one or more change applications before issuing a CPP.
The form for requesting CPP and the guidance document for completing the form is available on the Swissmedic website at www.swissmedic.ch. Swissmedic processes the request form electronically and converts it directly into CPP format according to WHO standards. Because the process is largely automated, it is particularly important to ensure that the information in the form is accurate in order to avoid errors in the CPP.
For more detailed information, you can access the full guidance document here.