Erlaubnis zum Verkehr mit Betäubungsmitteln Änderung

If you wish to change, extend or renew your permit to participate in the narcotics trade, you must submit a change application.

You can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for a change to an existing authorization:

• Amendment of a license
• Extension of a temporary authorization
• Extension of a license
• Waiver of a license

The BfArM will only approve the amendment application for the establishment already applied for and the necessary quantity of narcotics. For scientific or temporary projects, you will generally receive another temporary permit when applying for an extension.

For each change request for a permit, please state the narcotics number of the original request to which the change relates. You must also state

• the surname, first name or company name and address of the applicant
• for legal entities: as a rule, a current extract from the commercial register and the names of the persons responsible

• Proof of the required expertise of the persons responsible
• Declaration that the persons responsible can fulfill their obligations at all times
• Description of the location of the business premises with:
  • Place and, if applicable, parcel name
  • Street and house number
  • Building and building section
  • Construction of the building
• Description of the existing safeguards against the removal of narcotics by unauthorized persons
• Information on the type of legal narcotics traffic, e.g. trade, production or cultivation
• Type and expected annual quantity of narcotics to be produced or required

You are already in possession of a permit to participate in narcotics traffic.

You can apply to the Federal Institute for Drugs and Medical Devices (BfArM) online, informally in writing or in part using an application form to change your authorization to participate in the narcotics trade.

If you are applying for a change to a permit online:

• Go to the website of the federal portal and call up the online application. This will guide you step by step through the necessary information.
• If you are applying as an organization, you will need an ELSTER company account and an ELSTER organization certificate. If you are applying as a private individual, you will need a BundID account and
  • an electronic ID document, for example the online ID function of your ID card or the eID of your European home country
  • or an ELSTER certificate
• Upload the required documents as a file. The following formats are permitted: PDF, DOC, JPEG, PNG, XLS, ZIP with a maximum of 10 megabytes per file.
• The BfArM will check your information and documents.
• The BfArM will contact you if your information or documents are incomplete and will give you a deadline for subsequent submission.
• The BfArM will send you a certificate of authorization or a notice of refusal as well as a notice of costs.

If you apply for a change to a permit using an application form or in writing:

• Compose a cover letter with all the required information or fill out the application form on the BfArM website.
• Print it out and sign it.
• Send your informal application or the application form by post to the BfArM.
• The BfArM will check your details.
• The BfArM will contact you if your information or documents are incomplete and give you a deadline for submitting them.

The BfArM will send you a certificate of authorization or a notice of rejection and a notification of costs by post.

There is no deadline.

• Objection
• Detailed information on how to lodge an objection can be found in the notification.
• Appeal to the administrative court

• existing authorization to participate in the narcotics trade can be changed at the Federal Institute for Drugs and Medical Devices (BfArM) with regard to:
  • Amendment of a license
  • Extension of a temporary authorization
  • Extension of the permit
  • Waiver of a permit
• the BfArM only approves changes for the establishment applied for and the respective necessary volume of narcotics
• for scientific or temporary projects, the permit is usually limited in time again