Apply for an import license for raw materials

If you import raw materials from non-EU countries, you must apply for an import permit.

You require an import permit to import basic substances of category 1 into the European Union (EU). You apply for this at the Federal Institute for Drugs and Medical Devices (BfArM). The authorization will only be granted if you are established in the European Union.

The prerequisite for applying for an import permit is a permit to import basic substances of category 1.

The permit is only valid for one import operation and for a maximum duration of 6 months and for a maximum of two basic substances covered.

You must apply for an import permit when you bring the raw materials into the customs territory of the European Union. It is required if you use the raw materials as follows

• for free circulation - even after outward processing
• for the customs warehousing procedure
• for inward processing
• for the processing procedure
• for temporary admission

You do not need an import permit if you import category 1 raw materials for the following purposes:

• unloading or transhipment only
• temporarily store
• store in a free zone of control type I or a free warehouse
• to be placed under the EU external transit procedure

You also do not need to apply for a permit to import category 2, 3 and 4 precursors.

• Application for import authorization containing the following information:
  • Name and address of the importer, exporter, final consignee
  • Description of the substances covered
  • Quantity and weight of the basic substances
  • Details of the transportation modalities
• Authorization to import category 1 precursors

If the recipient of the goods is based in another EU country, you must enclose a copy of their permit with the application for import authorization.

• You are based in Germany.
• You have a permit to import category 1 raw materials.

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

You can apply in writing to the Federal Institute for Drugs and Medical Devices (BfArM) for an import license for basic substances of category 1.

• You fill out the application form for the import authorization of basic substances on the BfArM website.
• Print out the application form, sign it and send it to the BfArM by post. Alternatively, you can scan the application and send it to the BfArM by e-mail.
• The BfArM will check your details.
  • The BfArM will notify you if you need to submit additional information.
• If you are granted the import permit, the BfArM will send you the import permit in duplicate and a fee notice by post.

You pay the fees within 30 days.

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

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

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