Apply for a WHO certificate for the export of medicinal products for human use without a marketing authorization in the exporting country
Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)
Service Description
Are you based in Germany and would like to export a medicinal product that is not authorized in Germany for use in humans to a country outside the EU? Then you need a WHO certificate.
To export medicinal products from Germany, you must apply for a WHO Certificate for Pharmaceutical Products (CPP). You need the WHO certificate in the importing third country for all regulatory situations relating to the local approval and import of your medicinal product. This may be necessary
- as part of marketing authorization applications in the exporting country
- in the context of applications for renewal, extension, variation or review of a marketing authorization in the exporting country
- when importing medicinal products authorized in the exporting country
Germany participates in the "World Health Organization (WHO) Certificate System on the Quality of Pharmaceutical Products in International Trade".
The certificates are issued by the competent authority of the federal state in which the medicinal product is manufactured (exporting country).
Who submits the application?
You can apply for the WHO Certificate for Pharmaceutical Products (CPP) as a
- manufacturing company
- company exporting the medicinal product
If the
- competent authority of the country of destination
wishes to apply for the certificate, it requires written authorization from you.
Additional services
As part of the application, you can request additional services for the certificate if necessary. These can be, for example
- Over-authentication by the Federal Office of Justice
- Legalization by the diplomatic or consular mission of the importing country in Germany
- Sealing with thread
You can find out which additional services you require from the competent authority to which you wish to submit the certificate.
Teaser
Are you based in Germany and would like to export a medicinal product that is not authorized in Germany for use in humans to a country outside the EU? Then you need a WHO certificate.
Process flow
You must apply for the WHO Certificate for Pharmaceutical Products (CPP) in writing using the application form. The form is written in German and in one other language. These are English, French or Spanish.
You must submit all the necessary documents with the application. If you do not have a marketing authorization for the medicinal product in Germany, you must prove that the competent authority of the country of destination has approved the import and that it is aware of the reasons for the lack of marketing authorization.
When applying in writing, you must apply for a separate WHO certificate for each medicinal product and for each importing country.
You must also observe the requirements of the competent national authority.
What are the fees?
Administration fee: 75,00 EURPayment in advance: noJede weitere Anlage, die geprüft wird, kostet 20 EUR.
Administration fee: 20,00 EURPayment in advance: no
What deadlines do I have to pay attention to?
There is no legal deadline.
Processing duration
Processing time: 6 - 8 Weeks
Legal basis
Appeal
- Objection
- Action before the administrative court
- within one month of notification
What else should I know?
The following information is available:
- The declaration of authorization status for a pharmaceutical product is not part of the application procedure.
- Batch certificates for pharmaceutical products are not part of the application procedure. Such a certificate is only applied for if state batch tests are prescribed for the product.
