WHO Certificates

Germany participates in the "World Health Organization (WHO) Certificate System on the Quality of Pharmaceutical Products in International Trade". These certificates certify the marketability of the medicinal product in the country issuing the certificate. They serve to facilitate the trade of medicines. The Paul-Ehrlich-Institut (PEI) issues basically two types of certificates:

• Certificate of a Pharmaceutical Product (CPP)
• Batch Certificate of a Pharmaceutical Product (BCPP)

Further Information

Advice Batch Certificate of a Pharmaceutical Product (BCPP)

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Certificate of a Pharmaceutical Product

The authority of the exporting country in which the medicinal product is authorised issues the certificate of a pharmaceutical product (CPP). The competent authorities of the importing third countries will use this CPP for:

• authorisation applications,
• applications for renewal, extension, modification or review of an authorisation,
• import of medicinal products authorised in the exporting country.

In Germany, CPPs are issued in the vast majority of cases by the competent authorities of the federal states. If it concerns the confirmation of authorisation-related information for medicinal products that are nationally authorised in Germany and were the authorisation holder is located outside of Germany, the higher federal authorities are also responsible for the issuing of certificates (see Section 73a sub-section 2 Medicinal Products Act (Arzneimittelgesetz, AMG)).

For applications, please use the CPP templates under "Further Information" and refer to the "Instructions to Applicants for the Issuance of WHO Certificates for Pharmaceutical Products (CPPs)".

The Paul-Ehrlich-Institut does not issue CPPs for centrally approved drugs. Please contact the European Medicines Agency (EMA) in this regard (see link below).

Contact

Please submit the filled CPP form via Email to eSubmission@pei.de.

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