To export a medicinal product for human use approved in Germany to a country outside the EU, you need the WHO certificate, which is issued in accordance with the requirements of the World Health Organization (WHO).

Germany participates in the "World Health Organization (WHO) Certificate System on the Quality of Pharmaceutical Products in International Trade". Certificates according to this system certify the marketability of the medicinal product for human use 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). For medicinal products manufactured outside Germany, only authorization-related information can be certified. In this case, the GMP (Good Manufacturing Practice) information is certified in the country of manufacture. 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".

A WHO certificate can be used by the competent authorities of importing third countries in the following regulatory situations:

• in the context of marketing authorization applications
• in the context of applications for renewal, extension, variation or review of a marketing authorization
• for the import of medicinal products authorized in the exporting country