Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)" and the purpose of this guidance is to demonstrate the steps involved in completing the request form.
In Switzerland, Swissmedic offers confirmations to companies with valid pharmaceutical establishment licenses that are issued by Swissmedic. In accordance with World Health Organization (WHO), one type of confirmation is referred to as a product certificate, also called a Certificate of a Pharmaceutical Product or CPP.
CPPs are official confirmations that describe companies involved and the authorized medicinal product in a structured manner for foreign regulatory agencies.
Swissmedic only accepts CPP requests from authorized representatives and this applies to both export licenses and Swiss market authorizations. It is not possible to issue a CPP for medicinal products that are manufactured in Switzerland but not authorized.
Information from the request form is processed electronically at Swissmedic and converted directly into the CPP format. All information in the request form will be transferred as it appears in the form and can only be corrected by submitting a new corrected request form.
Click this LINK to know more details about the basic rules and the instructions on how to fill out the form. You can download the form by clicking this LINK.
Also, click to know about the recent "Guidance document Authorisation in accordance with Art. 14para.1 abis-quater TPA"
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