Psychedelic medicines are unlike any other treatment. A revolutionary potential to heal, in the most delicate of contexts. Wrapped in restrictive legal controls for decades, frequently misunderstood and presenting some of the most novel legal risks in modern medicine.
This industry needs lawyers with a genuine understanding, background and passion for the sector. That is why the award winning legal team at the heart of the cannabis industry are here to do all we can to help the psychedelic medicines sector flourish.
Working with psychoactive substances carries a plethora of novel legal and practical risks, embedded in a particularly difficult regulatory regime.
Whether you are working directly with these compounds and patients, or concerned in the licensing, supply and distribution, the benefits of using a specialist legal partner who is familiar with the substances and the context in which they operate will be paramount to the safety and success of your business or research endeavours.
Specialist regulatory and commercial services for the psychedelic medicines sector:
- Patents and other intellectual property protection
- University spinouts
- Pricing and reimbursement systems, competition law and data protection issues
- Full range of medical and commercial cannabis services see Cannabis Law section
- MHRA Wholesale Dealer’s Licences
- MHRA Manufacturer’s Licences
- MHRA Manufacturer’s “Specials” Licences
- Advice and registration of medical devices
- Nutraceuticals, bioceuticals and nootropics regulation
- Schedule 1 Controlled Drugs Licence applications (and all other Home Office controlled drug licences)
- Regulatory advice and legal opinions for start-ups, ongoing ventures, labs, service providers, prospective investors, and those undertaking due diligence on the psychedelic medicines sector
- Specialist advice for psychoactive substance clinical trials, and clinical trial agreements
- Commercial contracts and distribution advice
- Investigational Medicinal Product licence applications
- MHRA marketing authorisation applications
- Pharmacovigilance activities and ADR reporting
- Import / export, and distribution advice for APIs and controlled substances
Policy, individual and legal reform for the psychedelic medicines sector:
- Domestic and international advice to state entities in relation to proposed legislation and legal frameworks
- Assistance with legislative change, white papers and reports
- Speaking slots
- Patient access representation and human rights challenges
- Criminal law psychoactive substances charges – individual and commercial specialist representation