Dell Tech guides companies through Canada’s OTC drug approval process, from product classification and DIN registration to labeling and Health Canada submissions, ensuring your over-the-counter products meet every regulatory requirement for safe and compliant market access.
Products like hard-surface disinfectants and wipes became essential during the COVID-19 pandemic. Health Canada’s interim measures for these products have now ended, meaning companies must obtain a Drug Identification Number (DIN) under the New Biocides Regulations before they can sell or import disinfectants in Canada.
Our experts guide companies through the complex approval process for disinfectant products and biocides, ensuring their formulations meet Health Canada’s safety and efficacy standards.
Dell Tech reviews your product formula to confirm that all active and inactive ingredients are permitted under Canadian regulations. We assess alignment with approved OTC monographs, validate ingredient functions, and identify any substances that may raise red flags during the approval process.
Our team determines whether your product qualifies as an OTC drug, a natural health product, or another regulatory category. We take a risk-based approach to classification, helping you avoid missteps that can delay approval or result in unnecessary reclassification later in the process.
Dell Tech prepares and submits complete DIN applications on your behalf. This includes preparing the appropriate documentation, verifying packaging and labeling requirements, ensuring required quality records and data are on file, and submitting the application through Health Canada’s Drug Submission Platform. We manage all correspondence to ensure your application stays on track.
We provide flexible consulting support to help answer regulatory questions and support product launch planning. Whether you need assistance reviewing safety data, interpreting Canadian OTC guidance documents, or creating a long-term compliance roadmap, Dell Tech is here to support your team.
Health Canada provides drug monographs that outline permitted active ingredients, therapeutic indications, doses, and labeling for specific types of OTC drugs. These monographs serve as a fast-track option for approval if your formulation and claims match the criteria. Dell Tech helps assess whether your product aligns with an existing monograph and, if not, guides you through the custom submission process.
Labeling plays a critical role in OTC drug compliance. Labels must meet strict formatting, ingredient listing, claims, and bilingual presentation rules. Dell Tech performs detailed label reviews, ensures all required statements and formatting are present, and provides accurate French translations in accordance with Canadian bilingual labeling requirements.
Even after an OTC product is approved, companies are responsible for staying compliant with changing regulations. Dell Tech offers ongoing support, including monitoring Health Canada updates, advising on formula or packaging changes, and assisting with DIN renewal or modification. We help your team stay proactive in meeting compliance obligations over the life of your product.
Canadian OTC regulations have a significant impact on the food and drug industry by setting safety,efficacy, and quality standards for over-the-counter products. These regulations ensure that consumers have access to safe and effective treatments for common health issues without requiring a prescription. Additionally, OTC regulations influence product labeling, marketing and post-market surveillance to maintain consumer safety and confidence in the industry. By requiring that OTC products meet certain standards and requirements, Health Canada aims to protect public health and provide accessible and reliable treatments for common health issues.
Dell Tech supports companies in navigating OTC regulations and gaining compliance by providing expert guidance on regulatory requirements and obligations. Dell Tech helps to identify non-compliance issues and develop compliance strategies. Additionally, Dell Tech assists with the preparation of regulatory filings and reporting and keeps clients updated on any regulatory changes to OTC regulations so that they can maintain a compliant business environment.
Obtaining OTC approval involves specific requirements and processes to ensure the safety and efficacy of the products. Based on Dell Tech’s review, the product will either be a Drug, requiring a Drug Identification Number (DIN) or a Natural Health Product, requiring a Natural Product Number (NPN). There may be a requirement for submission of clinical data to determine the drug’s safety and efficacy. This depends on the presence of active ingredient(s) and/or claims in the marketplace/package. Health Canada reviews the submission, assesses the product’s benefits, risks, labeling and potential impact on public health before granting approval for over-the-counter sale. Dell Tech is involved during the review process, fielding any questions or concerns that the Health Canada reviewer may have.
Yes, Dell Tech provides assistance in classifying, preparing and submitting OTC drug applications to Canada’s regulatory authorities through its specialized expertise and services. Dell Tech guides companies through the entire application process, ensuring that all necessary documents and data are compiled accurately and comprehensively. Dell Tech also conducts a thorough review of the product’s formulation, labeling, safety data and efficacy studies to meet regulatory standards.
Labeling, packaging and advertising of OTC products are crucial components of ensuring consumer safety and informed decision-making. The most important considerations are clarity and accuracy in OTC product labels to meet the mandatory requirements. Examples include the Drug Facts Table, label text , appropriate warnings and precautions, and truthful advertising and claims. These considerations aim to empower consumers to make well-informed decisions about OTC products, mitigate potential health risks, and maintain the integrity and credibility of the industry.
Dell Tech helps companies navigate Canadian OTC drug regulations, including DIN registration, classification, labeling, and compliance with Health Canada. Contact us today to get started.
