Einfuhrgenehmigung Betäubungsmittel Erteilung

If you wish to import narcotics into Germany, you must apply for an import permit from the Federal Institute for Drugs and Medical Devices (BfArM). Under certain circumstances, you can also apply for a clearance certificate instead.

To be able to apply for an import permit, you need a permit to handle narcotics (BtM permit). The permit is valid for a maximum of 3 months, for imports by sea for a maximum of 6 months.

After you have imported the narcotics, you must immediately inform the Federal Institute for Drugs and Medical Devices (BfArM) of the process in an import notification. If you do not import the narcotics within the period specified in the import permit, you must also report this in an import notification immediately after the period has expired.

If the substance or preparation in question is not subject to narcotics legislation in Germany, you may require a clearance certificate as a substitute for the import permit. This clearance certificate officially certifies that a substance or preparation is not subject to narcotics legislation in Germany.

The application procedure for clearance certificates is primarily aimed at trading companies, in particular from the pharmaceutical sector, which trade in medicinal products or active substances across borders on the basis of pharmaceutical legislation. You can also use the application procedure if you:

• are a scientific institution or
• are a company that supplies scientific institutions with reference solutions.

The clearance certificate is intended exclusively for submission to the foreign authority responsible for narcotics traffic. It serves as a substitute for an import permit in accordance with the Narcotics Act (BtMG) and the Narcotics Foreign Trade Ordinance (BtMAHV). This certificate is required to obtain a corresponding export license from the authority responsible for narcotics traffic abroad.

The Federal Opium Agency at the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the import license and the clearance certificate.

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 import is to be made
• 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

• 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.

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

• Fill out the import authorization application form.
• 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.

There are no indications or special features.

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

• Authorization for importing narcotics into Germany Import authorization required
• In addition, a permit to handle narcotics (BtM permit) is required
• After import, import notification is mandatory and immediate
• Import permit valid for a maximum of 3 months, for imports by sea for a maximum of 6 months
• Alternatively, if required: application for a clearance certificate for substances or preparations that are not subject to narcotics legislation in Germany
• Clearance certificate serves as a substitute for an import permit in accordance with the Narcotics Act (BtMG) and the Narcotics Foreign Trade Ordinance (BtMAHV) for submission to the foreign authority responsible for narcotics traffic
• Clearance certificate valid for 1 year in each case