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If you wish to export medicinal products to non-EU third countries, you will need a certificate. This certificate must comply with the certificate system of the World Health Organisation (so-called WHO certificates).
A WHO certificate can be applied for in the following cases:
Regierungspräsidium Tübingen - Control centre for pharmacovigilance Baden-Württemberg
WHO certificates can be issued at the request of the pharmaceutical company or at the request of the competent authority of the export destination country.
The marketing authorisation holder for the medicinal product to be exported must be based in Baden-Württemberg
You can apply for the certificates from the office responsible for the pharmaceutical company that wishes to export the medicinal product. For Baden-Württemberg, this is the Baden-Württemberg Drug Monitoring Centre at the Tübingen Regional Council. The WHO certificate forms must be completed and submitted in advance by the applicant. The link to the forms can be found under "Notes".
not applicable
You need the pre-completed WHO certificate template (product-related / authorisation status). Please submit this as a Word document (file format "docx").
Fees are charged for the issue of WHO certificates in accordance with the state fee schedule. Depending on the scope or effort involved, these range from 25 to 500 euros.
The processing time depends, among other things, on
- the number of medicinal products for which a WHO certificate is requested
- the scope of the individual applications
{0} Sozialministerium Baden-Württemberg
