Leverage our flexible consulting services assistance for DIN Number registration, PLL Compliance, Drug Label Compliance, Establishment License (EL) Registration & Renewal, and Health Canada Pre-Submission Meeting. Based on the current Health Canada Amendments, our Health Canada team will conduct an exhaustive assessment and consult at every level of the Product License Applications process.
Over-the-counter (OTC), prescription medications, radiopharmaceuticals, biologics, and gene therapies are all drug types. OTC Pharmaceuticals, often known as non-prescription drugs, are health items available in the Canadian market that may be purchased without a medical prescription. Evidence of safety and efficacy must be supplied, whether it be pre-cleared information from OTC drug monographs or clinical trials undertaken on the innovative medication. OTC medications are regulated by Health Canada to guarantee their safety and to reduce health hazards to Canadians.
OTC Drugs to be sold in Canada require a Drug Identification Number (DIN Number). This DIN 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.
There are several monograph categories for Over-the-Counter (OTC) Drugs in Canada. These include Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).
Any company (domestic or international) that manufactures, distributes, or imports OTC pharmaceuticals must provide proof that they adhere to GMP.
A mandatory requirement to fabricate (manufacture), package, label, test, import, distribute, or wholesale a finished drug or bulk process intermediate drug.
Only applies to NHP, medical devices, dietary supplements, vet health product
Our Canadian OTC Regulatory Experts are backed with extensive knowledge and years of experience. We offer OTC compliance consulting services for all types of companies to lessen the regulatory risk and assure a speedy way for the launch of your OTC drug.
With more than a decade of experience, we will help you by reviewing complete drug application requirements and preparing your application to apply for and receive a Drug Identification DIN Number from Health Canada.
Former Health Canada officers will guide you on how to submit a meeting request, prepare for discussion as well as attend meetings with you to offer support with Health Canada officials.
Worried about Plain Language Labeling (PLL) compliance and French Translation? Don't worry. We ensure your drug application will meet language requirements and contain the PLL format label when submitted.
Wondering how to get an Establishment License? We offer complete support to register your facility for an Establishment License along with annexing foreign sites to Canadian import license holders.
A Drug Identification Number (DIN Number) is a computer-generated eight-digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada. A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.
Through Health Canada’s Plain Language Labelling Initiative, there are new requirements for health product labelling and packaging, including a requirement for a Drug Facts Table (Facts Table) on the outer label of non-prescription drugs. The standardized format of the Drug Facts Table will help consumers find important product information quickly and easily.
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