Meldung zum Grundstoffverkehr Registrierung

If you have a permit or registration to handle certain basic substances or export certain basic substances, you must report this annually to the Federal Institute for Drugs and Medical Devices (BfArM).

The handling of precursors that could potentially be used in the illegal manufacture of narcotics is subject to strict controls.

Precursors are divided into the following categories:

• Category 1: precursors that can potentially be converted into drugs with a high potential for dependence and abuse
• Category 2: Substances that can be used for the illicit manufacture of narcotics
• Category 3: Solvents and acids
• Category 4: Medicinal products and veterinary medicinal products containing ephedrine or pseudoephedrine or the salts of ephedrine or pseudoephedrine.

If you are involved in the basic substance trade, you must report your processes to the Federal Institute for Drugs and Medical Devices (BfArM) every year. The reporting obligation applies if you

• a license for precursors of category 1 or
• have a registration for category 2 precursors,
• you export Category 3 precursors to a listed country with an export license requirement or
• export Category 4 precursors to countries outside the European Union (EU).

In the notification, you must provide information on

• the consumption of category 1 precursors,
• exports and imports of category 1 and 2 precursors,
• the sale of category 1 and 2 raw materials within Germany and the EU,
• brokerage transactions that include drop shipments with countries outside the EU,
• exports of Category 3 precursors to a listed country with an export license requirement, and
• exports of Category 4 precursors.

You must report your transactions as long as your license or registration is valid. Even if you have not participated in precursor traffic despite a valid permit or registration, you must report this in a so-called false report.

You do not have to report your transactions if you are a

• pharmacy,
• police and
• customs authority or
• have a special permit or
• only process category 2A substances.

You must report the following documents:

• Overview of all transactions relating to the basic material traffic in the past year

• You are based in Germany.
• You own
  • a permit to handle category 1 precursors or
  • a registration for handling precursors of category 2 (A and B) or
  • have exported Category 3 precursors to listed countries of destination or
  • exported Category 4 precursors.

There are no costs.

You can submit the notification for the basic substance traffic online, by post or e-mail to the Federal Institute for Drugs and Medical Devices (BfArM).

Submit the notification online:

• Go to the website of the federal portal verwaltung.bund.de and access the online form. This will guide you step by step through the necessary information, which you can enter electronically.
  • You will need an Elster company account and an Elster certificate for the declaration.
• Upload the declaration as a file and send the declaration. The uploaded files must not be larger than 10 megabytes each.
• You can upload the following file types:
  • PDF
  • PNG
  • JPG
• The BfArM will check your information and
• informs you of any discrepancies. If necessary, you must submit a correction report.

Submit the notification by post or e-mail:

• Complete the notification form on the BfArM website.
• Send the form
  • by e-mail to the BfArM or
  • print out the form and
  • send it to the BfArM by post.
  • The BfArM will check your details and notify you of any discrepancies. If necessary, you must submit a correction report.

Processing can take several months.

You must submit the notification by February 15 of the following year for the previous calendar year.

There are no indications or special features.

Not applicable

• Raw materials are divided into the following categories:
  • Category 1: precursors that can potentially be converted into drugs with a high potential for dependence and abuse
  • Category 2: Substances that can be used for the illicit manufacture of narcotics
  • Category 3: Excipients or solvents
  • Category 4: Medicinal products and veterinary medicinal products containing ephedrine or pseudoephedrine or the salts of ephedrine or pseudoephedrine
• Notification obligation exists for
  • Authorization for precursors of category 1
  • Registration for precursors of category 2 (A and B)
  • Export of category 3 precursors with export authorization requirement
  • Export of Category 4 precursors
• Exemption from the obligation to register exists for
  • Special permit for
    • pharmacies
    • Police and customs authorities
    • German Armed Forces
  • Exclusive use of category 2A raw materials
• Notification annually by February 15 of the following year at the latest for the previous calendar year
• Notification obligation exists as long as the authorization for precursors of category 1 or registration for precursors of category 2 (A and B) is valid
• notification must also be submitted as a so-called false notification if participation in precursor traffic is suspended
• Notification possible online by post or e-mail
• Responsible: Federal Institute for Drugs and Medical Devices (BfArM)