Apply for evaluation of mixtures containing basic substances
Do you handle mixtures containing basic substances that can be used for the manufacture of narcotics? Then you can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for an examination to determine whether handling restrictions also apply to the mixture.
Description
The handling of substances that can be used for the production of narcotics is subject to special restrictions.
For these so-called
- precursors
- drug precursors
- substances
the Federal Opium Agency at the Federal Institute for Drugs and Medical Devices (BfArM) issues the corresponding licenses upon application.
Mixtures containing precursors are also considered to be precursors. They are therefore subject to the same regulations. Unless the mixtures are composed in such a way that the basic substances cannot simply be used or easily extracted. This assessment is carried out by the BfArM.
If you handle mixtures containing basic substances, you can apply to the BfArM for an assessment of whether the respective mixture is classified as a basic substance or not.
Online service
Apply online for evaluation of mixtures containing basic substances
Description
Use this service online
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 – software certificate
Contact person
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Bundesopiumstelle
Address
address
Contact
telephone: +49 228 99307-5114
telephone: +49 228 99307-5104
fax: +49 228 99307-5194
e-mail: poststelle@bfarm.de
e-mail: grundstoffe@bfarm.de
Internet
Required documents
- Informal letter with all necessary information or completed online application
- optional: safety data sheet
- optional: certificate of analysis
Prerequisites
- Your place of residence or registered office is in Germany.
Basis for legal action
- Verordnungen (EG) Nr. 273/2004 des Europäischen Parlaments und des Rates vom 11. Februar 2004 betreffend Drogenausgangsstoffe
- Verordnung (EG) Nr. 111/2005 des Rates vom 22. Dezember 2004 zur Festlegung von Vorschriften für die Überwachung des Handels mit Drogenausgangsstoffen zwischen der Union und Drittländern
Legal remedy
- Contradiction
Procedure
You can apply for the testing of mixtures containing basic substances online or informally by post, fax or e-mail to the BfArM.
If you apply for testing 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, which you can enter electronically.
- To submit the application, you will need
- an Elster company account
- an Elster certificate.
- To submit the application, you will need
- Upload the required documents as a PDF, PNG or JPEG file with a maximum of 10 megabytes per file and send the application.
- You will receive a confirmation of receipt.
- The BfArM will check your details and documents.
- The BfArM will notify you if you need to submit additional information or documents.
- You will receive the result of the assessment.
If you request the assessment informally by post, fax or e-mail:
- Compose a cover letter with:
- Your full name
- Your full address
- your telephone number
- Fax number, if available
- your e-mail address
- all other required information such as the name of the mixture containing the base substance and the percentage of all substances contained in the mixture containing the base substance according to the safety data sheet or the certificate of analysis
- Send your informal application to the BfArM by:
- Post,
- fax or
- You will receive the result of the assessment.
Deadlines
There is no deadline.
Processing time
7 days
Costs
There are no fees.
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 14.11.2025
Keywords
BfArM, Export, Federal Opium Agency