All phytocannabinoids are regulated under the Cannabis Acts and Regulations, meaning that CBD is controlled in the same way as any other cannabinoid, including THC. Health Canada oversees the production and sale of cannabis products, including any that contain CBD. Even products derived form industrial hemp fall under the Cannabis Act’s ambit, and only authorized producers can legally make and sell CBD products. 

The Cannabis Act and Regulations strictly control the possession, production, distribution and sale of cannabis. 

Cannabidiol Services in Canada

• Compilation and preparation of cultivation, processing, research, analytic testing, and retail licences
• Advice on regulatory compliance of ingredients, products, and packaging
• Label review and creation
• Scientific literature review to determine acceptability under the Cannabis Act
• Assistance with preparation and maintenance of regulatory documents
• Document review to identify gaps to ensure compliance 
• HACCP and preventive control plan development
• Good manufacturing processes for edibles processing 
• Advertising compliance review
• Auditing and verification
• Training and education
• Product Development

General Regulatory Guidance

• Clinical trials
• Business plan
• Online training
• Adverse event reporting
• Post-licence gap analysis
• Amendment preparation
• Notification preparation
• Regulatory strategy and oversight
• Sop review and gap analysis
• Inspection & monitoring reports and rmi’s
• Mergers and acquisitions regulatory due diligence.

Many countries in Europe have legalized CBD and have developed their own regulatory frameworks for the production and sale of the compound. The unique regulatory environment for each country is a serious challenge for would-be producers, especially as the EU considers CBD a novel food and looks to restrict access to CBD products. The European CBD market continues to grow, despite the possibility that CBD may become a restricted or medical-only product in many EU countries. 

CBD services for the EU

• EU GMP certification preparation and guidance
• Product development
• Novel food legislation guidance and support
• Import and export agreements & border control issue resolution
• Label and packaging compliance
• Market authorization
• Training and Education
• Site and documentation gap analysis
• Documentation services
• Compliant and accurate translation services
• Clinical trials
• Facility design
• Marketing and advertising guidance
• Food safety & quality
• Regulatory strategy and oversight
• SOP development, review and Gap Analysis
• Mergers and acquisitions regulatory due diligence
• PlanClaim Development

CBD producers require prior regulatory approval for marketing and selling their product in the UK.  

Since CBD, unlike TCH, is not an intoxicant, it is not a controlled substance under the Misuse of Drugs Regulations 2001.

The EU reviewed CBD’s status as a novel food in 2019, and because it found no history of CBD consumption in Europe prior to 1997, it mandated that all CBD based food ingredients must first undergo a safety assessment before they can be marketed as food products. 

The UK completed its transition from Brexit in January 2021 and now, the Food Standards Agency assesses novel food authorization applications for CBD. 

CBD novel food authorization services in the UK

• Evaluation of existing safety data for your ingredient
• Identification of technical and scientific data gaps and recommendation of solutions
• Coordination of toxicological studies when required
• Literature review and data gathering 
• Preparation and submission of novel food applications and liaison with FSA