Apply for a license to trade in raw materials

Source: BUS Rheinland-Pfalz

The handling of precursors that can potentially be converted into drugs is subject to strict controls, especially if they are category 1 precursors that can be used to produce drugs with a high potential for dependence and abuse.

You require a permit for any handling of these precursors. This is the case if you

possess
manufacture
process
store them
trade with them
arrange transactions with them
carry out drop shipments, even if the raw materials do not touch the territory of the European Union (EU)
import into the EU
export from the EU

The permit is not transferable. It is issued by the competent authority of the EU member state in which you are established. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible.

To obtain a license, you must appoint a person as the responsible representative. The responsible representative ensures that the applicable regulations on basic substances are complied with and is the contact person for the BfArM. The person must be authorized to represent you and make the necessary decisions to comply with the applicable regulations on basic substances.

They submit the initial applications or applications for new licenses for the handling of:

Basic substances
operations
operating sites

The permit you receive may be limited to 3 years or require renewal after 3 years.

The competent authority may suspend or revoke the permit if you no longer meet the requirements for granting the permit.

You can submit all applications online or informally in writing. Both initial applications and applications for renewal are subject to a fee.

Customs agents and freight forwarders are exempt from the obligation to obtain a permit if they act exclusively in this capacity. Pharmacies, police and customs authorities as well as the German Armed Forces have been granted a special permit by the BfArM. This special permit is only valid within the scope of the respective official area of responsibility.

You can apply online or informally in writing to the BfArM for a permit to handle category 1 precursors.

Apply for 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, which you can enter electronically.
- You will need the following for the application:
  - an Elster company account
  - an Elster certificate.
Upload the required documents as a PDF, PNG or JPEG file with a maximum size of 10 megabytes each and send the application.
If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM.
If you are granted authorization, the BfArM will send you the authorization certificate by post together with a notification of fees.

Apply for a permit informally in writing:

Draw up an application with all the required information, print it out and sign it.
Send your informal application to the BfArM by post.
If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM.

If you are granted authorization, the BfArM will send you the authorization certificate by post together with a fee notice.

Your complete details:
- Name
- your address
- telephone number
- Fax number, if available
- e-mail address
Designation and Combined Nomenclature (CN) code of the required raw materials and their salts
For mixtures:
- the name of the mixture
- the name and CN codes of all the basic substances contained in the mixture
- an indication of the maximum possible content of such basic substances in the mixture
description of the operations envisaged, for example
- Trade in the European Union
- Further processing
- import
- export
- Brokerage
- Intermediary transactions
completed declaration form for the appointment of the responsible agent(s)
current police clearance certificate of the appointed responsible agent(s)
certified extract
- from the commercial register or
- certified copy of the business registration

Apply for a license to trade in raw materials

Process flow

Requirements

Which documents are required?

What are the fees?

What deadlines do I have to pay attention to?

Processing duration

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