Apply for testing of substances under narcotics law
Would you like to have a substance tested under narcotics and basic substance legislation? Then you can submit a corresponding application to the Federal Institute for Drugs and Medical Devices (BfArM).
Description
If you are unsure whether a substance falls under the Narcotics Act or the Basic Substances Monitoring Act, you can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for an examination of the substance.
An examination by the BfArM as to whether a substance falls under the Narcotics Act or the Basic Substances Monitoring Act is subject to a fee. Before you apply for this, you should therefore check whether the substance in question is already included in the list of narcotics on the BfArM website.
Online service
Apply online for testing of substances under narcotics law
Description
Use this service online
Payment methods
- Transfer
Trust level
You need an Elster certificate with password to use this online service (trust level: substantial).
further information on the level of trust for online services
Identification
- electronic identification using national eID means - identity card
- electronic identification using national eID means – software certificate
Contact person
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Bundesopiumstelle, Fachgebiet 82
Address
address
Contact
Internet
Payment methods
The following payment method is possible: Transfer
Required documents
- Name of the substance
- Structural formula of the substance (optional)
- optional: additional information on the substance, e.g. Chemical Abstracts Service number (CAS number)
Prerequisites
- You are based in Germany.
Basis for legal action
- § 1 Bundesgebührengesetz in Verbindung mit Abschnitt 1 der Anlage zu § 2 Absatz 1 Besondere Gebührenverordnung des Bundesministeriums für Gesundheit für die individuell zurechenbaren Leistungen in seinem Zuständigkeitsbereich (BMGBGebV)
- § 1 Absatz 1 Betäubungsmittelgesetz (BtMG)
- Anlage I zu § 1 Absatz 1 Betäubungsmittelgesetz (BtMG)
- Anlage II zu § 1 Absatz 1 Betäubungsmittelgesetz (BtMG)
- Anlage III zu § 1 Absatz 1 Betäubungsmittelgesetz (BtMG)
Legal remedy
- Appeal against the cost assessment notice
- Detailed information on how to lodge an objection can be found in the decision.
- Appeal against the cost assessment notice to the administrative court
Procedure
You can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for the classification of substances under narcotics and basic substance legislation online or by post or e-mail.
Apply for classification 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 certificate. If you are submitting the application as a private individual, you will need an electronic ID document (e.g. the online function of your ID card) and a BundID account.
- If required, upload the documents as a file and send the application. The file must not be larger than 10 megabytes. The following formats are accepted:
- PNG
- JPEG
- DOC
- XLS
- ZIP,
- CDX
- CDXML
- CHM
- The BfArM will check your information.
- The BfArM will notify you if you need to submit additional information or documents.
- You will receive the classification under narcotics law and a notification of costs by post. Pay the fees.
Apply for classification by post or e-mail:
- Write an informal letter with details of
- Your person or company,
- your narcotics number - (if available) and
- as detailed information as possible about the substance.
- Send the letter by post or e-mail to the BfArM.
- The BfArM will check your details.
- The BfArM will notify you if you need to submit additional information or documents.
- You will receive the classification under narcotics law and a notification of costs by post. Pay the fees.
Deadlines
There is no deadline.
Processing time
14 days
Costs
Prüfung je Stoff, der bereits in der Datenbank hinterlegt ist: 50,00 EUR: Fee 50,00 EUR (Information on cost composition can be found here)
Prüfung je Stoff, der neu recherchiert wurde: 70,00 EUR: Fee 70,00 EUR (Information on cost composition can be found here)
Notes (specifics)
There are no indications or special features.
Further Information
Area of validity
Germany-wide
Official approval
Officially approved by Federal Ministry of Health (BMG) on 27.03.2025
Keywords
BfArM