Regulatory Affairs and Licensing

MCS Associates has a long and successful history of regulatory leadership by bringing practical experience and expertise with product registration and facility licensing and compliance. Understanding what license you need to sell supplements is crucial for ensuring that your business complies with all regulatory requirements. We assign a dedicated resource as a single point of contact. This way we can help you stay compliant with implementation of regulatory strategies, ensuring timely preparation, review and submission of documents to Canadian and international regulatory authorities.

License Applications and Registrations

• Government Registrations (DIN/NPN/Medical Devices/OTC)
• Site Licenses
• Establishment License
• Wholesale / Import / Distribute Licenses
• Product Licenses
• Product Classification & Registration

We frequently address queries like do you need a license to sell vitamins and supplements, ensuring that your business adheres to all necessary regulations. To learn more, Contact Us today to speak to our amazing team of qualified experts.

Compliance (Label and Claims)

• Label & Marketing Literature Review
• Claims Substantiation

Our comprehensive services include clarity on what license do you need to sell supplements to maintain regulatory compliance and guidance on Labeling and Marketing.

Cannabis Licensing

Applies to Edibles and Cannabis Health Products

Licensing Support
– Standard Cultivation & Micro-Cultivation
– Standard Processing & Micro-Processing
– Sale for Medical Purposes
– Analytical Testing
– Research
– Nursery

For additional Cannabis services, visit Cannabis and CBD

Medical Device Licensing

• Medical Device Risk Classification
• Medical Device Application
• Fax Back Forms
• License Annual Renewal
• Establishment License/Annual Renewal
• Health Claims Review

For additional services, visit Medical Devices

Food and Beverage

• Food Safety/Compliance (HACCP/PCP)
• Food Facility Registration
• Nutritional Analysis / Nutrition Facts Table (NFT)
• Temporary Market Authorization (TMA) (i.e. Energy Drinks)
• Allergen Control Program

For additional services, visit Food and Beverages

Cosmetics and Personal Care

• Cosmetic Notifications
• Cosmetic Formulation Ingredient Analysis

For additional services, visit Cosmetics and Personal Care

Low Risk Veterinary Products

What license do you need to sell supplements and vitamins? We provide in-house consultation expertise on Veterinary Health Products (VHPs) to Canadian Manufacturers, Importer, Distributors. VHPs are low risk drugs in dosage form and contain ingredients such as vitamins, minerals and traditional medicines. They are used to maintain or promote the health and welfare of companion and/or food-producing animals and are not for use to treat, prevent or cure disease. Do you need a license to sell vitamins and supplements? Contact Us to learn more and the next steps to get the license required for your business.

Services include:

1. Notification (i.e. obtain Notification Number)
2. Review of the VHP labels
3. Health Claims Review
4. Act as a Representative in Canada [for importers]

Companies must notify Health Canada about their VHPs:

1. At least 30 days before selling a VHP in Canada
2. At least 30 days before making a change to a VHP that have been already notified
3. Before importing a VHP into Canada

Businesses often ask, “What license do you need to sell supplements?” The answer typically involves more than just one type of license. We provide clear guidance and support to meet all regulatory requirements for all your needs. Let’s set up a call to help get you and your business started.