Apply for a certificate for a pharmaceutical product (CPP) in accordance with the World Health Organization (WHO) certification system for the export of medicinal products for human use

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 specifications of the World Health Organization (WHO).

Germany participates in the "World Health Organization (WHO) certification system for the quality of pharmaceutical products in international trade". trade". Certificates under 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) in accordance with Section 73a (2) AMG. 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".

If it concerns the confirmation of marketing authorization-related information and the marketing authorization holder is based outside Germany, the higher federal authorities are responsible for issuing WHO certificates.

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

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

WHO certificates can be applied for by the marketing authorization holder (pharmaceutical company), by the manufacturer, by the exporter of the medicinal product authorized in Germany or by the competent authority of the country of destination. You must submit all documents required for the decision to issue the WHO certificate.

Before a WHO certificate is issued, the certifying authority checks the information for accuracy and completeness.

Hessian State Office for Health and Care

Please contact the Hessian State Office for Health and Care (HLfGP).

• The content of the prepared WHO Certificate for Pharmaceutical Products (CPP)
• Declaration that no change has been made outside the fields provided in the form on file (only in the case of a paper-based application)
• If applicable, the package leaflet/information leaflet approved by the competent national supervisory authority
• Complete composition of the pharmaceutical form, if applicable
• Summary of the basis for authorization, if applicable
• If an authorized representative is applying for the certificate, declaration of consent of the marketing authorization holder (power of attorney)

Forms available: Yes

Written form required: No

Informal application possible: No

Personal appearance necessary: No

Online services available: Yes

• You must be the marketing authorization holder, manufacturer or a person or authority of the country of destination authorized by the marketing authorization holder.
• If you are not the marketing authorization holder, the permission of the marketing authorization holder/authorized representative is required.

An appeal against this decision may be lodged with the competent administrative court (depending on the registered office of the authorization holder or applicant) within one month of notification.

• Depending on the competent authority, you have the option of submitting the application via the online form or in writing.
• If you submit the application using the online form, you submit the data from the online application, the automatically generated WHO certificate and the required attachments to the automatically determined competent authority online.
• In the case of a paper-based application, send the completed WHO draft with the required documents by post and, if necessary, also by email to the competent authority.
• 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 the service is offered by the competent authority and you have also applied for over-certification, the requested over-certification will be carried out.
• You will receive the requested certificate and the fee notice by post.
• Payment is made afterwards (bank transfer after receipt of the fee notice)

As soon as the required documents are complete and correct, the certificate is usually issued within 2 to 4 weeks of the application. after the application is submitted. If special additional certifications have been applied for, the processing time is not included.

• The administrative fee varies depending on the competent authority.
• Additional costs are incurred depending on the type of additional certification requested.

• The applicant must submit all documents and information relevant to the decision to issue the WHO certificate.
• In cases where an authorized person applies for a WHO certificate, the approval of the marketing authorization holder is required. A corresponding written authorization must be submitted.
• The requirements of the WHO template must be complied with. Non-relevant passages in the text must not be omitted, i.e. empty fields in sectionssections for which no statement can or should be made remain empty. Additions for the sake of transparency (e.g. trade name in the recipient country) can be included in an annex if necessary.
• For applications that are not submitted via the online application tool, a declaration must be submitted stating that no changes have been made outside the fields provided on the form.
• In the case of online applications, it is possible to apply directly for WHO certificates for several importing countries for one medicinal product authorization number.
• In the case of a paper-based application, a separate certificate must be applied for per medicinal product, i.e. per authorization number, and per importing country.
• Attachments belonging to the certificate must be enclosed in neutral form (without company logo; does not apply to samples, e.g. the package leaflet) and at least in German. Another official WHO language (English, French, Spanish) can be considered. The required forms can be found on the ZLG homepage (see further information).
• The certifying authority must ensure that the information is correct and up-to-date.
• The official language is German in accordance with § 23 of the Administrative Procedure Act. The foreign language part (according to the official WHO translation) of the synoptic certificate is neither signed nor sealed/stamped by the authority (see also section 3.10 of the WHO guidelines). A synoptic certificate may be issued in a language for which the WHO does not provide an official translation upon submission of a translation by an officially recognized translator whose signature must be notarized.
• The "General information" and "Explanatory notes" are an integral part of each certificate and must always be attached. Please also note the explanations of the individual sections in the annex to the WHO certificate and the WHO guidelines.
• The declaration of authorization status for (a) pharmaceutical product(s) is not part of this application procedure.
• Batch certificates for pharmaceutical products are not the subject of this application procedure. Such a certificate is applied for by the manufacturer and only issued by the higher federal authority conducting the batch test, the Paul Ehrlich Institute (PEI), if state batch tests are prescribed and carried out for the product. Information on batch testing can be found on the PEI website.