Applying for an export license for narcotics

You can apply for the export license in writing by post:

• Fill out the export license application form.
• Print out the application form so that the front and back are on one sheet, sign it and send it together with all the necessary documents by post to the Federal Institute for Drugs and Medical Devices (BfArM).
• The BfArM will check your details and documents.
• The BfArM will notify you if you need to submit additional information or documents.
• If you are granted the export license, the BfArM will send you the export license in duplicate and a notification of fees by post. Pay the fees within 30 days.

You can apply for the clearance certificate online, by post or fax from the BfArM.

If you apply for the clearance certificate online:

• Go to the website of the federal portal and access the online application. This will guide you step by step through the necessary information, which you can enter electronically.
• You will need an ELSTER business account and an ELSTER certificate to submit the application.
• Upload the required documents as a file and send the application. The file must not be larger than 10 megabytes. The following formats are accepted:
  • PDF
  • PNG
  • JPEG
• The BfArM will check your information and documents.
• The BfArM will notify you if you need to submit additional information or documents.
• You will receive the clearance certificate and a notification of costs by post. Pay the fees within 30 days.

If you apply for a clearance certificate by post or fax:

• Compose an informal written application on the headed paper of your institution including commercial register number with details of
  • Your organization,
  • your BtM number, if available, and
  • detailed information on the substance and
  • detailed information on the country of export
• Send the letter and all required documents to the BfArM by post or fax.
• The BfArM will check your information and documents.
• The BfArM will notify you if you need to submit additional information or documents.
• You will receive the clearance certificate and a notification of costs by post. Pay the fees within 30 days.

• You are based in Germany or the applicant organization is based in Germany.
• You or the applicant organization have a permit to handle narcotics in order to participate in narcotics traffic.
• You or the applicant organization have the corresponding import permit of the importing country.
• For a clearance certificate, it is necessary that you
  • are an organization or a company based in Germany that regularly trades in medicinal products or active substances on the basis of the German Medicinal Products Act or
  • are a scientific institution or a company that regularly supplies scientific institutions with reference solutions or other chemicals for scientific purposes.

For export license:

• Narcotics (BtM) number
• Permit for handling narcotics
• Import permit of the importing country

For clearance certificate:

• chemical structural formula, including molecular formula and molecular weight of the substance or the substance in the preparation
• Chemical name according to the "International Non-proprietary Name of the World Health Organization" (INN) or the "International Union of Pure and Applied Chemistry" (IUPAC)
• Chemical Abstracts Service (CAS) number, if available
• Details of the country to which the product is to be exported
• If applying as an organization without an existing permit to handle narcotics: Header sheet of the organization with:
  • Specification of the commercial register number or
  • BtM number

• § Section 11 of the Narcotics Act (Betäubungsmittelgesetz - BtMG)

• Contradiction
  • Detailed information on how to lodge an objection can be found in the notification.
• Administrative court action

There are no indications or special features

01.04.2025