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Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)

Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a Pharmaceutical Product (CPP)".

A Certificate of Pharmaceutical Product (CPP) is a document issued by a regulatory authority in a country or region that confirms the status of a pharmaceutical product as being authorized for sale and/or distribution in that country or region.

It gives information about the product, including its name, formulation, strength, and dosage form, and also identifies its manufacturer and marketing authority and is mainly required by regulatory authorities in other countries as part of the registration process for importing and selling the product in their jurisdiction.

In Switzerland, Swissmedic issues a product certificate to companies who hold a valid pharmaceutical establishment licence issued by Swissmedic (official term: Certificate of a Pharmaceutical Product; CPP).

This guidance aims to guide the applicants through the process of completing the request form. Swissmedic electronically processes the information in the request form and converts it directly into the WHO's CPP format. Since the process is heavily automated, it is especially important that the information in the form be accurate to prevent mistakes.

Click this LINK for requesting the form requesting CPP and click this LINK for more information on the process for requesting Product certificates.


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