Applying for an import permit for narcotics

You can apply for the import permit in writing by post:

• Fill out the application form for import authorization.
• Print out the application form so that the front and back are on one sheet, sign it and send it by post to the BfArM together with all the necessary documents.
• 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 import permit, the BfArM will send you the import permit 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 PDF, PNG or JPEG file with a maximum of 10 megabytes per file and send the application.
• The BfArM will check your details 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 the 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
  • 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 have a permit to handle narcotics in order to participate in narcotics traffic.
• To obtain a clearance certificate, you must
  • are an organization or a company 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 import authorization:

• Narcotics (BtM) number
• Permission to handle narcotics

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 from which the product is to be imported
• If applying as an organization without an existing permit to handle narcotics: Header sheet of the organization with
  • details of the commercial register number or
  • BtM number

• § 11 Gesetz über den Verkehr mit Betäubungsmitteln (Betäubungsmittelgesetz - BtMG)
• §§ 1 bis 6 Betäubungsmittel-Außenhandelsverordnung (BtMAHV)
• Abschnitt 1, Nummern 9, 9.1 und 11.2 Besondere Gebührenverordnung des Bundesministeriums für Gesundheit für die individuell zurechenbaren Leistungen in seinem Zuständigkeitsbereich (Besondere Gebührenverordnung BMG - BMGBGebV), Anlage (zu § 2 Absatz 1)

• 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