Dear Community,
The regulatory landscape in Germany is currently undergoing a significant transformation. The core element is the planned amendment of the New Psychoactive Substances Act (NpSG), which will substantially adjust the framework for research, scientific analysis, and the handling of innovative chemical compounds. The political objective is clear: to prevent misuse while safeguarding legitimate scientific work [2].
The German Federal Government has explicitly reaffirmed the importance of the constitutional principle of legal certainty (Bestimmtheitsgebot). This ensures: no vague catch-all prohibitions, no undefined analogue chains, and no retroactive regulations. Legitimate research remains permissible and legally predictable.
“Broader formulations [...] would contradict the constitutional principle of legal certainty and would open up infinite variations.” [1] [3]
The guiding principle of policy remains clear: Protect public health, but do not restrict responsible scientific research.
Timeline: Key Milestones
- 15 August 2025: Submission of the draft law to the Federal Council (Bundesrat) [2]
- 26 September 2025: Federal Council discussion; call for extended structural prohibitions [3]
- 02 October 2025: Bundestag bulletin (hib); rejection of blanket analogue bans [1]
- 08–09 October 2025: Presentation of the Sixth Amendment Regulation [4]
- 21 November 2025: Expected publication in the Federal Law Gazette
- 22 November 2025: Regulation enters into force (the day after publication)
Legal Background and Immediate Effect
Under German law, a statutory regulation enters into force the day after its publication in the Federal Law Gazette, unless a different date is explicitly defined. For the Sixth Amendment Regulation to the NpSG, an immediate entry into force has been announced. This means that, as of 22 November 2025, all substances listed in the regulation will automatically fall under the scope of the NpSG and can no longer be freely traded in Germany.
In light of this, we have decided to discontinue open sales on 14 November 2025. This ensures a transparent and fully documented transition between general commercial availability and the subsequent research-only distribution phase. It also guarantees that all outgoing shipments are lawfully processed and completed prior to the regulation taking effect.
Continued Distribution for Scientific, Industrial and Research Purposes
As of 15 November 2025, controlled distribution will continue exclusively for verified users whose usage is recognized under the current state of science and technology as a legitimate industrial, commercial, or scientific application. This procedure is fully aligned with Section 1(2) of the NpSG, which explicitly exempts such applications from the general prohibition.
Eligible recipient groups include:
- Existing wholesale customers with prior legitimacy verification
- Recognized research laboratories, universities, and scientific institutions
- Companies with verified analytical or industrial research purposes
All orders in this category will undergo manual verification, contractual documentation, and internal archival for compliance purposes. This ensures full traceability and adherence to all legal and documentation requirements under the NpSG.
Transparency and Retrospective: The Decision of 24 October 2025
On 24 October 2025, following the release of the latest NpSG documentation, we temporarily suspended all affected products and removed them from public sale. The trigger was an internal compliance alert originating from our regulatory monitoring system.
The development of the law was first detected on 10 October 2025, extensively evaluated by 15 October 2025, and operationally implemented shortly thereafter following internal consultation.
Reference to the initial announcement: Important Information on the NpSG – 24 October 2025
The decision was correct; however, communication could have been more proactive. We are learning from this feedback.
Enhanced Compliance and Communication Procedures
- Structured multi-phase information process for regulatory events
- Early-stage internal risk assessment and product classification
- Clear separation between commercial and research-based distribution
- Continuous monitoring of legislative developments
- Comprehensive documentation and traceability of all transactions
Transition Phase and Controlled Research Distribution
The regular sale of affected substances will remain possible until 14 November 2025. After this date, the following rules will apply:
- Distribution exclusively to verified research institutions and industrial partners
- Mandatory legitimacy verification and contractual documentation
- Complete record-keeping in line with NpSG compliance requirements
This approach ensures that legitimate research and analytical work can continue within a legally sound and fully transparent framework, consistent with recognized standards of science and technology.
Currently Available Substances
Update 07 November 2025: Limited remaining stock of O-DSMT HCl is available – while supplies last. The regulated restock process is currently underway and expected to conclude by mid to late November.
Outlook: Stability and Scientific Direction
We continue to evolve our portfolio responsibly, focusing on:
- Legally compliant compound classes with documented legal definitions
- Scientifically relevant and analytically verified substances
- Validated laboratory reports and stable supply chains
- Transparent communication with research partners
In parallel, we are evaluating additional natural, analytical, and legal product categories. New substances will only be introduced after thorough legal review, laboratory verification, and certified quality assurance.
Our continued investments focus on:
- Supply chain stability and traceability
- Digital compliance infrastructure and contract automation
- Harm reduction, education, and scientific collaboration
- Community engagement and research dialogue
Our mission remains clear: to ensure a stable, compliant, and science-driven research environment.
Your Remicals.de Team