Substance Law provides legal and regulatory services to organizations and individuals operating in Canada’s highly regulated psychedelics and controlled substances sector. We advise clients on licensing, compliance, audits, enforcement, transactions, and regulatory strategy involving substances regulated under the Controlled Drugs and Substances Act (CDSA) and overseen by Health Canada.
Psychedelic substances such as psilocybin, MDMA, LSD, DMT, mescaline, and other controlled substances are subject to strict federal controls. Navigating this legal framework requires careful planning, regulator-aware strategy, and ongoing compliance support.
Psychedelics Legal Services
CDSA Dealer’s Licences & Authorizations
We assist clients with regulatory pathways to lawfully engage in activities involving psychedelics, including:
- Dealer’s Licence applications
- Licence amendments and scope changes
- Regulatory strategy for research, manufacturing, and commercialization
- Responding to Health Canada questions and deficiencies
Licensing is often the cornerstone of lawful psychedelic operations in Canada.
Research, Clinical Trials & Medical Access
We advise clients involved in psychedelic research and therapeutic development, including:
- Regulatory strategy for research activities
- Interactions with Health Canada related to trials and studies
- Compliance obligations for controlled substances
- Risk management for investigators and sponsors
We support both early-stage research and more advanced clinical or therapeutic programs.
Compliance Programs & Operational Readiness
Licensed or authorized activities come with strict operational obligations. We assist with:
- Security and site compliance planning
- Record-keeping and inventory controls
- Standard operating procedures (SOPs)
- Internal compliance programs and audits
Ongoing compliance is critical to maintaining authorization and avoiding enforcement action.
Inspections, Audits & Enforcement Matters
We represent clients in connection with:
- Health Canada inspections and audits
- Warning letters and notices of non-compliance
- Licence suspensions, refusals, or revocations
- Enforcement risk assessment and remediation
Early legal involvement can significantly affect regulatory outcomes.
Import, Export & International Operations
We advise on:
- Import and export permits for controlled substances
- Cross-border regulatory requirements
- Coordination with international partners and regulators
- Ongoing reporting and compliance obligations
International movement of psychedelics is closely scrutinized and must be carefully managed.
Transactions, Investment & Commercial Agreements
We support psychedelic businesses with:
- Regulatory due diligence for investments and acquisitions
- Structuring transactions involving licensed activities
- Drafting, reviewing, and negotiating commercial agreements
- Risk allocation in research, manufacturing, and supply contracts
Regulatory status and compliance posture are often central to deal viability.
Who We Assist
We advise a wide range of clients in the psychedelics space, including:
- Researchers and research institutions
- Biotech and pharmaceutical companies
- Manufacturers and laboratories
- Clinical trial sponsors
- Importers and exporters
- Investors and strategic partners
Why Choose Substance Law as Your Psychedelics Lawyer?
- Experience with CDSA and Health Canada frameworks
- Practical understanding of licensing and compliance risk
- Strategic, business-focused legal advice
- Support from early research through commercialization
- Toronto-based firm serving clients across Canada
Work With a Psychedelics Lawyer in Canada
If you are researching, producing, importing, exporting, or commercializing psychedelic substances in Canada, Substance Law provides experienced legal guidance tailored to CDSA-regulated activities.
Contact us today to speak with a Psychedelics Lawyer in Canada.
Frequently Asked Questions About Psychedelics Lawyers in Canada
Is it legal to possess, produce, or sell psychedelics in Canada?
Many psychedelics (including psilocybin, MDMA, LSD, DMT, and mescaline) are controlled substances in Canada. Activities involving controlled substances are generally prohibited unless specifically authorized by Health Canada under the Controlled Drugs and Substances Act (CDSA) and related regulations.
What does a psychedelics lawyer do?
A psychedelics lawyer helps clients navigate Canadian controlled substances law, including licensing strategy, compliance program development, import/export permitting, audit and inspection readiness, enforcement response, and legal support for transactions and contracts in regulated operations.
What is a CDSA Dealer’s Licence and when is it needed?
a CDSA Dealer’s Licence is a Health Canada authorization that may allow certain activities with controlled substances such as production, possession, sale, distribution, import/export, and research or analytical testing—subject to strict conditions. Whether you need a Dealer’s Licence depends on your activities and business model.
Can you help with Health Canada inspections, audits, or warning letters?
Yes. We help clients prepare for inspections and audits, respond to Health Canada correspondence (including warning letters and compliance notices), address findings, and implement remediation strategies to reduce enforcement risk.
Do you advise on importing and exporting psychedelics?
Yes. We advise on permit strategy and compliance for import and export of controlled substances, including regulatory requirements, documentation, and communications with Health Canada related to cross-border activity.
Can you help with compliance programs and SOPs?
Yes. We assist clients with operational compliance frameworks, including security planning, inventory controls, record-keeping systems, SOPs, internal audits, and governance processes aligned with licensing and regulatory requirements.
Do you help with contracts and transactions in the psychedelics sector?
Yes. We provide contract drafting, review, and negotiation as well as regulatory due diligence and transaction support for investments, acquisitions, manufacturing arrangements, supply agreements, and research collaborations involving regulated activities.
Can you advise researchers, clinics, and companies?
Yes. We advise a range of clients, including researchers, clinical trial sponsors, labs, manufacturers, importers/exporters, and businesses involved in regulated psychedelic activities.
How long does it take to obtain a Dealer’s Licence?
Timelines vary based on application complexity, site readiness, security requirements, and Health Canada review. Applications may take several months and can involve follow-up questions or requests for additional information.
How much do psychedelics legal services cost?
Costs depend on the scope of work—such as licensing applications, compliance program development, audits/inspections, import/export permitting, or transactions. Many matters can be handled on an hourly or scoped fixed-fee basis after an initial review.
