OTC Drugs to be sold in Canada require a Drug Identification Number (DIN). This number on a product label indicates the drug has met all requirements for quality, safety, and effectiveness. Canadian firms that are engaged in manufacturing, packaging, labeling, and importing non-prescription drugs must be licensed for these activities. Similarly, any company intending to produce OTCs in USA is required to ensure that their product meets the standards for safety and efficacy. They should ensure whether they are compliant with GMPs and meet the labeling requirements as set out in 21 CFR part 201.66. The process of meeting the requirements of Health Canada and FDA can be complex in many cases.  Let Quality Smart Solutions help you prepare your OTC application accurately and efficiently.