Apply for a WHO certificate (CPP) for the export of medicinal products
Source: BUS Rheinland-PfalzGermany participates in the "World Health Organization (WHO) Certificate System on the Quality of Pharmaceutical Products in International Trade". Certificates under this system certify the marketability of the medicinal product in the country of origin and serve to facilitate the movement of medicinal products.
In principle, the certificates are issued by the competent authority of the federal state in which the medicinal product is manufactured and authorized (exporting country) in accordance with Section 73a (2) AMG. For medicinal products manufactured outside Germany, only authorization-related information can be certified. In this case, the GMP information is certified in the country of manufacture (GMP - Good Manufacturing Practice). The WHO certificate with GMP information certifies that the medicinal product complies with the "WHO principles for the manufacture of medicinal products and the assurance of their quality".
If it concerns the confirmation of marketing authorization-related information and the marketing authorization holder is based outside Germany, the higher federal authorities are responsible for issuing WHO certificates.
A WHO certificate can be used by the competent authorities of importing third countries in the following regulatory situations:
- in the context of applications for marketing authorization
- in the context of applications for renewal, extension, modification or review of a marketing authorization
- for the import of medicinal products authorized in the exporting country
WHO certificates can be applied for by the marketing authorization holder (pharmaceutical company), the manufacturer or the exporter of the medicinal product authorized in Germany. You must submit all documents required for the decision to issue the WHO certificate.
Before a WHO certificate is issued, the certifying authority checks the information for accuracy and completeness.