All drugs sold in Canada must undergo premarket review and be issued a drug identification number (DIN) prior to sale in Canada, even if the FDA has already approved them. In order to receive this number the drug must be proven safe, effective and of high quality.
At SNI we compile a high quality submission and help you navigate the sometimes-intense regulatory process, minimizing time delays and getting your product into the market as quickly as possible.
We have years of experience in compiling DIN applications and creating compliant label solutions for over the counter drugs and prescription drugs.
In addition, companies involved in the fabrication, packaging/labeling, testing, importation, distribution and/or wholesaling of drugs must possess a valid Establishment License. On your behalf to help you obtain or renew your Establishment License we can:
- Evaluate your site
- Develop Standard Operating Procedures
- Train your staff
- Navigate the regulatory system
OVER THE COUNTER DRUGS
Over the counter drugs, or non-prescription drugs must be licensed by Health Canada in order to be legal for sale in Canada. A product will receive a Drug Identification Number (DIN) once it has been determined to meet criteria established by Health Canada for safety, efficacy and quality.
At Source Nutraceutical, our team of regulatory experts will help you through this licensing process and provide valuable knowledge to get your product into the market as quickly as possible while remaining 100% compliant to Canadian rules and regulations.
Prescription drugs are subject to premarket review, evaluation and licensing by Health Canada. Once products have been determined to meet established Health Canada criteria for safety, efficacy and quality they will be issued a Drug Identification Number (DIN) making them legal for sale in Canada.
Our regulatory team is well versed in this process and will help you get your product into the market quickly and stress-free. They have a great knowledge of Health Canada’s criteria regarding prescription medications and can assist you in making this process as simple as possible.