Dell Tech supports companies in registering OTC products for sale in Canada, managing DIN and NPN submissions, formula and label reviews, and establishment licensing to help ensure full compliance with Health Canada’s regulatory requirements from submission to market approval.
Registration is essential for ensuring that OTC drugs marketed in Canada are safe, effective, and properly labeled. A valid DIN or NPN gives consumers confidence and demonstrates that your product has met stringent Health Canada standards. Non‑compliance can result in product seizure, import refusals, fines, and reputational damage. That is why working with a regulatory firm such as Dell Tech is key to success.
We analyze your formulation to verify that active and inactive ingredients align with Canadian monographs and approved ingredient databases such as NHPID or DIN listings. Our team helps identify any non‑compliant components and suggest compliant reformulations when needed.
We determine whether your product qualifies as an OTC drug requiring a DIN or a natural health product (NHP) requiring an NPN. This critical decision influences submission strategy, data requirements, and application timelines.
Compliance with Canadian labeling includes required format, bilingual text, claims, and safety information. Our team performs a thorough review, annotates changes, and ensures accurate English and Canadian French translations.
We prepare a complete submission package for Health Canada, including dosage form description, claims justification, safety and efficacy data, and certificates required for DIN or NPN registration. We manage the online Drug Submission Platform process on your behalf.
Clients that manufacture, package, label, distribute, import, or test OTC products must hold a valid drug establishment licence. Dell Tech assists with licence application preparation, guidance on GMP compliance, and liaising with Health Canada inspectors as needed.
Once submitted, Dell Tech acts as your main point of contact with Health Canada for all communication, clarifications, and review responses. We keep you informed throughout the application process to help achieve timely approval.
Our work continues after approval. Dell Tech supports changes such as reformulations, updated labelling, or monograph updates. We also advise on adverse reaction reporting, product recall protocols, and ongoing compliance monitoring.
Dell Tech has registered thousands of OTC and NHPs across Canada through over 40 years of regulatory experience. Our team is recognized by Health Canada as trusted regulatory partners in DIN, NPN, and drug establishment licensing pathways.
Typical products with synthetic chemical active ingredients include antiseptic cleansers, sunscreens, acne treatments, hand sanitizers, cough and cold medications, and oral lozenges. Depending on formulation and claims, they require either DIN or NPN registration and drug establishment licensing.
Health Canada requires any facility that manufactures, packages, labels, distributes, imports, or tests OTC to hold a valid drug establishment licence. Dell Tech can prepare your application and guide you on operational and GMP requirements register.clinicaltrials.gov+9Government of Canada+9Dell Tech+9.
Time to approval depends on product type, data complexity, and pathway. Monograph-aligned OTC products may be faster, whereas custom DINs require more data. Dell Tech helps manage expectations and expedite whenever possible.
We assemble all regulatory documents, prepare label content, liaise with Health Canada, and manage any follow-up queries. Our team ensures your submission remains compliant and provides ongoing support until approval.
Dell Tech helps companies register OTC drugs for the Canadian market, including DIN or NPN submissions, formula and label review, establishment licensing, and Health Canada liaison. Contact us today to get started.
