Apply for registration to trade in commodities

You can apply online or informally in writing to the Federal Institute for Drugs and Medical Devices (BfArM) for registration to handle basic substances in categories 2 and 3.

Apply for registration online:

• Go to the website of the federal portal verwaltung.bund.de and call up the online application. 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 to submit the application.
  • Upload the required documents as a file (PDF, PNG, JPEG, maximum 10 megabytes per file) and send the application.
• The BfArM will check your details.
  • If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM.
• If you are granted registration, the BfArM will send you the registration certificate with a fee notice by post.
• Pay the fees.

Apply for registration informally in writing:

• Compose an application with all the required information, print it out and sign it.
• Attach the completed declaration form for the appointment of the responsible representative(s) to the application.
• Send your informal application by post to the BfArM.
• The BfArM will check your details.
  • If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM.
• If you are granted registration, the BfArM will send you the registration certificate with a fee notice by post.
• Pay the fees.

• You must be resident in Germany.
• The Federal Institute for Drugs and Medical Devices (BfArM) will check your application for completeness and plausibility. The BfArM also checks whether there are justified grounds for doubting the suitability and reliability of the applicant or the responsible representative(s) before issuing a registration for handling basic substances.
• You must apply for a new registration if
  • another basic substance is added,
  • a new process is to be included or
  • the location of your business premises where you carry out the operations changes.

You must submit documents with the following complete details:

• Name
• your address
• telephone number
• Fax number, if available
• e-mail address
• Designation and CN code of the required raw materials and their salts
• for mixtures:
  • the name of the mixture,
  • the name and CN codes of all the basic substances contained in the mixture, and
  • the maximum possible content of such basic substances in the mixture
• a description of the operations envisaged, for example
  • Trade in the European Union,
  • further processing,
  • import,
  • export,
  • mediation or brokerage
• If you handle category 2 raw materials: completed declaration form for the appointment of the responsible representative(s).

You must submit the application before you start work.

• Article 3(6) Regulation (EC) No 273/2004 of the European Parliament and of the Council of February 11, 2004 on drug precursors

• Contradiction
  • You will find detailed information on how to lodge an objection in the notification of your application for initial registration.

There are no indications or special features.

13.12.2024