Apply for a permit to participate in trade in narcotics

If you want to participate in the trade of narcotics, you must apply for a permit.

You need a permit if you wish to participate in the trade in narcotic drugs.

This applies, for example, to:

• Extension
• Production of narcotics and exempted preparations
• Trade including import and export
• scientific purposes
• clinical trials
• other placing on the market

The Federal Institute for Drugs and Medical Devices (BfArM) grants the authorization. You are only ever granted authorization for the requested operating site and the scope of narcotics that you require. For scientific projects, you generally receive a time-limited authorization.

For each type of handling of narcotics, there are separate requirements and application options, depending on the capacity in which you wish to participate in the trade in narcotics, for example as:

• Growers
• Trading company
• Manufacturer
• Study Physician
• university institution
• non-university research institution
• Authority

You must ensure with appropriate security measures that the narcotics cannot be unlawfully stolen or diverted. The respective security level depends on the type and quantity of the narcotics you intend to handle. You must coordinate the necessary security measures with the BfArM during the planning phase.

You can apply for the permit to participate in the trade in narcotics online, informally in writing, or partially via an application form at the Federal Institute for Drugs and Medical Devices (BfArM).

When applying for the permit online:

• Go to the federal portal website and open the online application. This will guide you step by step through the necessary information.
• If you are submitting the application as an organization, you need an ELSTER business account and an ELSTER organization certificate.
• If you are submitting the application as an individual, you need a BundID account as well as
  • an electronic identification document, for example the online ID function of your identity card or the eID of your European home country
  • or an ELSTER certificate
• Upload the required documents as a file. The permitted formats are PDF, DOC, JPEG, PNG, XLS, ZIP with a maximum of 10 megabytes per file.
• The BfArM is reviewing your information and documents.
• The BfArM will contact you if your information or documents are incomplete and will give you a deadline for submitting the missing items.
• The BfArM will send you a certificate of permission or a notice of rejection as well as a notice of fees.

If you request permission via an application form or in writing:

• Draft a cover letter with all required information or fill out the corresponding application form on the BfArM website.
• You print it out and sign it.
• Send your informal application or the application form by mail to the BfArM.
• The BfArM is reviewing your information.
• The BfArM will contact you if your information or documents are incomplete and will give you a deadline for submitting the missing items.

The BfArM will send you a certificate of permission or a notice of rejection and a fee notice by mail.

There is no deadline.

• Objection
• Detailed information on how to file an appeal can be found in the notice.
• lawsuit before the administrative court