WHO Certificates
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)
Updated: 07.01.2021
Certificate of a Pharmaceutical Product
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). This CPP will be used by the competent authorities of the importing third countries
- 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 registration-related information for medicinal products were the authorisation holder is located outside of Germany, the higher federal authorities are also responsible for the issuing of certificates (see 15th AMG amendment (Article 1 of the Act amending the law on medicinal products and other substances) Rules of 17 July 2009 (BGBl. I S. 1990) on 23 July 2009)
Contact
Please submit the filled CPP form via Email to [email protected]
Updated: 07.01.2021
