Report raw materials
If you have a permit or registration to handle certain basic substances or export certain basic substances, you must report this annually to the Federal Institute for Drugs and Medical Devices (BfArM).
Description
The handling of precursors that could potentially be used in the illegal manufacture of narcotics is subject to strict controls.
Precursors are divided into the following categories:
- Category 1: precursors that can potentially be converted into drugs with a high potential for dependence and abuse
- Category 2: Substances that can be used for the illicit manufacture of narcotics
- Category 3: Solvents and acids
- Category 4: Medicinal products and veterinary medicinal products containing ephedrine or pseudoephedrine or the salts of ephedrine or pseudoephedrine.
If you are involved in the basic substance trade, you must report your processes to the Federal Institute for Drugs and Medical Devices (BfArM) every year. The reporting obligation applies if you
- a license for precursors of category 1 or
- have a registration for category 2 precursors,
- you export Category 3 precursors to a listed country with an export license requirement or
- export Category 4 precursors to countries outside the European Union (EU).
In the notification, you must provide information on
- the consumption of category 1 precursors,
- exports and imports of category 1 and 2 precursors,
- the sale of category 1 and 2 raw materials within Germany and the EU,
- brokerage transactions that include drop shipments with countries outside the EU,
- exports of Category 3 precursors to a listed country with an export license requirement, and
- exports of Category 4 precursors.
You must report your transactions as long as your license or registration is valid. Even if you have not participated in precursor traffic despite a valid permit or registration, you must report this in a so-called false report.
You do not have to report your transactions if you are a
- pharmacy,
- police and
- customs authority or
- have a special permit or
- only process category 2A substances.
Online service
Meldung für den Grundstoffverkehr online einreichen
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
You must report the following documents:
- Overview of all transactions relating to the basic material traffic in the past year
Prerequisites
- You are based in Germany.
- You own
- a permit to handle category 1 precursors or
- a registration for handling precursors of category 2 (A and B) or
- have exported Category 3 precursors to listed countries of destination or
- exported Category 4 precursors.
Basis for legal action
- Artikel 8 Absatz 2 Verordnung (EG) Nr. 273/2004 des Europäischen Parlaments und des Rates vom 11. Februar 2004 betreffend Drogenausgangsstoffe
- Artikel 9 Absatz 2 Verordnung (EG) Nr. 111/2005 des Rates vom 22. Dezember 2004 zur Festlegung von Vorschriften für die Überwachung des
- Artikel 9 Delegierte Verordnung (EU) 2015/1011 der Kommission vom 24. April 2015 zur Ergänzung der Verordnung (EG) Nr. 273/2004 des Europäischen Parlaments und des Rates und der Verordnung (EG) Nr. 111/2005 des Rates zur Festlegung von Vorschriften für die Überwachung des Handels mit Drogenausgangsstoffen zwischen der Gemeinschaft und Drittländern sowie zur Aufhebung der Verordnung (EG) Nr. 1277/2005 der Kommission
- Artikel 10 Durchführungsverordnung (EU) 2015/1013 der Kommission vom 25. Juni 2015 mit Vorschriften in Bezug auf die Verordnung (EG) Nr. 273/2004 des Europäischen Parlaments und des Rates betreffend Drogenausgangsstoffe und auf die Verordnung (EG) Nr. 111/2005 des Rates zur Festlegung von Vorschriften für die Überwachung des Handels mit Drogenausgangsstoffen zwischen der Union und Drittländern
Legal remedy
Not applicable
Procedure
You can submit the notification for the basic substance traffic online, by post or e-mail to the Federal Institute for Drugs and Medical Devices (BfArM).
Submit the notification online:
- Go to the website of the federal portal verwaltung.bund.de and access the online form. 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 for the declaration.
- Upload the declaration as a file and send the declaration. The uploaded files must not be larger than 10 megabytes each.
- You can upload the following file types:
- PNG
- JPG
- The BfArM will check your information and
- informs you of any discrepancies. If necessary, you must submit a correction report.
Submit the notification by post or e-mail:
- Complete the notification form on the BfArM website.
- Send the form
- by e-mail to the BfArM or
- print out the form and
- send it to the BfArM by post.
- The BfArM will check your details and notify you of any discrepancies. If necessary, you must submit a correction report.
Deadlines
You must submit the notification by February 15 of the following year for the previous calendar year.
Processing time
Processing can take several months.
Costs
There are no costs.
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 13.12.2024
Keywords
Export