Apply for an export license for raw materials

If you export raw materials to non-EU countries, you must apply for an export license.

If you wish to export raw materials to a country outside the European Union (EU), you generally require an export license. You apply for this at the Federal Institute for Drugs and Medical Devices (BfArM).

Basic substances are divided into four categories. Depending on the category of the basic substance, different conditions apply to the export, which you must take into account when submitting your application.

• You always need a license to export category 1 and 2 precursors to a country outside the EU. To be able to apply for this, you need a license to export category 1 precursors and a registration for category 2 precursors.
• For the export of category 3 precursors, you only need a permit for certain countries outside the EU. A complete list of these countries can be found on the BfArM website. You must also be registered for the export of Category 3 precursors. This applies in particular if you exceed certain annual export quantities.
• For the export of category 4 precursors, you apply for a license without additional documentation.

The export permit is only valid for one specific export transaction of precursors. This means that you cannot use it more than once.

However, if you wish to export category 3 and 4 raw materials, you can apply for a simplified export authorization. To do so, you must have already received export licenses for your previous export activities and have proven that you meet all obligations arising from these exports without violating the applicable law. The simplified export authorization is valid for several export transactions with the same raw materials, the same exporter based in the EU and the same importer based in the country of destination within a maximum of 12 months.

• Application for an export license containing the following information:
  • Name and address of the importer, exporter, final consignee
  • Description of the substances covered
  • Quantity and weight of the raw materials
  • Details of the transportation modalities
• Permit or registration number depending on the category of the basic substance
• Copy of the importer's import permit in the country of destination (optional)

• You are resident in Germany.
• For category 1 precursors: You have a license to export category 1 precursors.
• For category 2 precursors: You have a registration for the export of category 2 precursors.
• For category 3 precursors if certain annual export quantities are exceeded: You have a registration for the export of category 3 precursors.

• Appeal
  • You will find detailed information on how to lodge an objection in the notification of your application for an export license.

You can apply for an export license for basic substances in writing to the Federal Institute for Drugs and Medical Devices (BfArM).

• You fill out the application form for the export license for basic substances on the BfArM website.
• You print out the application form, sign it and send it together with all the necessary documents by post to the BfArM or scan the application with all the necessary documents and send it to the BfArM by e-mail.
• 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 triplicate by post and a notification of fees.
• If you are granted a simplified export license, the BfArM will send you two copies of the export license and a fee notice by post.
• You pay the fees within 30 days.

You must submit the application before the export takes place and the export license must have been issued at the time of export.

Gebühr je Grundstoff bei einem Warenwert je Grundstoff von über 200,00 EUR: Fee 100,00 EUR (Information on cost composition can be found here)

Gebühr je Grundstoff bei einem Warenwert je Grundstoff von unter 200,00 EUR: Fee 50,00 EUR (Information on cost composition can be found here)