Authority for Justice and Consumer Protection

Apply for a WHO certificate for the export of medicinal products for human use

Prerequisites

• You are a marketing authorisation holder or pharmaceutical company, the competent authority of the country of destination or an applicant with a legitimate interest, such as a manufacturing company or co-distributor.
• If you are not the person or company that holds the marketing authorization for the medicinal product, you will need a written power of attorney from the marketing authorization holder.
• The person or company holding the license is based in Hamburg.
• The information and documents are correct and up-to-date.

Documents required

• Completed WHO Certificate of Product Quality (CPP) for pharmaceutical products
• If you are applying for the certificate in writing: Declaration that no changes have been made outside of the designated fields in the provided form.
• where applicable, the product or technical information approved by the competent national supervisory authority
• where applicable, a summary of the admission criteria
• If applicable, the declaration of consent from the license holder (power of attorney)
• all relevant documents and information
• If you are applying for a WHO certificate as an authorized representative: consent of the marketing authorisation holder, written power of attorney

You can obtain the certificate in a language for which the WHO does not offer an official translation. For this, you will need a translation from a state-certified translator with a notarized signature.

Please attach the certificate documents in a neutral format (without company logo; this does not apply to samples, such as the package leaflet) and in at least German. An additional official WHO language (English, French, Spanish) may be considered. The required forms can be found on the website of the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) (see links).

Please note

• If the marketing authorisation holder is not based in Germany, the federal authorities are responsible for WHO certificates that only concern marketing authorisation information – not the federal states.
• If the medicinal product was not manufactured in Germany, the competent authority can only confirm information relating to its marketing authorization. Manufacturing information (GMP) must be certified in the country of manufacture. GMP stands for "Good Manufacturing Practice." The WHO certificate with GMP information confirms that the medicinal product was manufactured according to the WHO's quality standards.
• The official language is German. The responsible authority does not sign, seal, or stamp the foreign-language part of the certificate.
• The "General Information" and "Explanations" are part of every certificate and must always be included. Please refer to the explanations for each item in the appendix to the WHO certificate and the WHO guidelines.
• This application cannot be used to confirm the marketing authorization status of one or more medicinal products.
• Batch certificates for medicinal products cannot be issued with this application. Such certificates are always applied for by the manufacturer. They are only issued by the responsible federal authority, the Paul Ehrlich Institute (PEI), if state-mandated batch testing is required and carried out for the product. Further information on batch testing can be found on the PEI website, which is linked below.

Deadlines

no

Procedure

• You can apply for the certificate online or in writing.
• If you apply for the certificate online:
  • You can apply for certificates for multiple importing countries for each drug product registration number.
  • You fill out the application form online.
  • You submit the application form, the automatically generated WHO certificate, and the required documents online to the responsible authority. The responsible authority is automatically determined during the online process.
• If you are applying for the certificate in writing:
  • You need a separate certificate for each medicinal product, that is, for each marketing authorization number and each country of import.
  • You will need to complete the WHO draft form (see links). Please adhere to the guidelines in the draft. Leave blank any fields where you cannot or should not provide information. Include any additional information, such as the trade name in the recipient country, in an appendix if necessary.
  • You send the completed draft and the required documents to the responsible authority.
• The responsible authority will review your application and documents. If necessary, they will request further documents or information from you.
  • The responsible authority will decide on your application and issue your certificate.
  • You will receive the requested certificate and the fee notice.
  • You pay the fees.

Processing time

The processing time is 2 - 4 weeks.

Fees

Fees apply. The amount of the fee depends on the individual case.

Legal remedies

Lawsuit before the Administrative Court

Legal basis

Section 73a of the German Medicines Act (AMG)


https://www.gesetze-im-internet.de/amg_1976/__73a.html




Section 77 of the German Medicines Act (AMG)


https://www.gesetze-im-internet.de/amg_1976/__77.html