WHO-Zertifikat (CPP) für die Ausfuhr von Arzneimitteln zur Anwendung bei Menschen Ausstellung bei inländischen Zulassungsinhabern

Do you need a WHO certificate for the export of pharmaceutical products? You can apply for this from the competent authority.

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

• Fully completed certificate template
• Instructions for use or technical information on the product as an attachment (if required)

• Marketing authorization holder, manufacturer and exporter according to the German Medicines Act based in Thuringia
• Competent authority in the country of destination
• Application using the WHO certificate templates

• At the Thuringian State Office for Consumer Protection (TLV), you have the option of submitting the application via the online form or in writing.
• If you submit the application via the online form, the data will be used automatically to create the WHO certificate and the attachments.
• In the case of a paper-based application, send the completed WHO draft certificate with the required documents to the TLV by post and, if necessary, also by email.
• The application and documents will be checked for accuracy and completeness. If the legal requirements are met and all information is correct and up to date, the WHO certificate will be issued.
• If you apply for over-certification, your application will be forwarded to the competent authority.
• You will receive the requested certificate and the fee notice by post.
• Payment is made afterwards (bank transfer after receipt of the fee notice).

Contradiction

• WHO certificate (CPP) for the export of medicinal products for human use Issued to domestic marketing authorization holders

Please contact the Thuringian State Office for Consumer Protection (TLV) - Pharmacy Department.