Medicinal products; application for a WHO certificate for export

A certificate in accordance with the World Health Organization's certificate system must be applied for in order to export medicinal products.

Online Antrag auf Ausstellung eines WHO-Zertifikats für die Ausfuhr von Arzneimitteln
With this online application you can apply for the issuance of a certificate in accordance with the certificate system of the World Health Organization for the export of medicinal products in accordance with Section 73a of the German Medicines Act (AMG) (for medicinal products for human use) or in accordance with Article 98 of Regulation (EU) 2019/6 (veterinary medicinal products).

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At the request of the pharmaceutical entrepreneur, the manufacturer, the exporter or the competent authority of the country of destination, the competent authorities shall issue a certificate for the export of medicinal products in accordance with the certificate system of the World Health Organization (WHO) pursuant to Section 73 a (2) of the German Medicinal Products Act (AMG).

Responsibilities

The governments of Upper Bavaria and Upper Franconia are responsible for issuing the export certificate.

The government of Upper Bavaria is responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia, while the government of Upper Franconia is responsible for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.

An authority in the country of destination requires an export certificate.

List of medicines to be administered according to the WHO scheme
Country of destination
Complete composition of the dosage form, if applicable
If applicable, the approved instructions for use/technical information
List of manufacturers, if applicable
If an authorized representative applies for the certificate, declaration of consent from the approval holder

If an export certificate (certificate of origin) is required by the authorities of the country of destination for the export of medicinal products, you as a pharmaceutical company can apply for it from the competent authorities.