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Selling OTC drugs or working with controlled substances in Canada means navigating Health Canada’s regulatory framework. The requirements are specific and the pathways are distinct. Since 2007, we have helped drug companies, research organizations, and controlled substances operators get registered, licensed, and compliant.
Health Canada regulates OTC drugs under the Food and Drugs Act and its associated regulations. Before a drug product can be sold in Canada, it needs a Drug Identification Number (DIN) confirming Health Canada has reviewed the formulation, labelling, and manufacturing standards. Companies distributing or importing drugs also need a Drug Establishment Licence (DEL) to authorize their facility and activities.
For organizations working with scheduled substances such as psilocybin, MDMA, or pharmaceutical narcotics, the Controlled Drugs and Substances Act (CDSA) applies, and a Dealer’s Licence or Section 56 exemption from Health Canada is required before any activities can begin.
The regulatory pathway varies depending on whether your product is an OTC drug following a monograph, a new drug requiring a full submission, or a controlled substance requiring CDSA authorization. Getting the right licence or registration in place before you begin, and maintaining it as your operations evolve, is what keeps your products on the shelf and your programs running without disruption.
Operating without the right approvals in place, whether a DIN, a DEL, or a CDSA licence, exposes your organization to product seizure, import refusal, programme shutdown, or enforcement action from Health Canada. Beyond the regulatory risk, there is the commercial cost: delays set back launches and research timelines by months. We help you avoid both.
A Drug Identification Number (DIN)
Every drug sold in Canada must have a DIN issued by Health Canada. The DIN confirms that the product’s ingredients, strength, dosage form, and labelling have been reviewed and accepted.
A Drug Establishment Licence (DEL)
Any company fabricating, packaging, labelling, testing, importing, distributing, or wholesaling drugs in Canada must hold a valid DEL that covers those specific activities.
GMP Compliance
DEL holders must meet the Good Manufacturing Practice requirements set out in Division 2 of the Food and Drug Regulations. This covers facilities, equipment, personnel, documentation, testing, and quality systems.
Compliant Labelling
OTC drug labels must meet Health Canada’s requirements for bilingual text, ingredient listing, directions for use, warnings, and DIN display. Labels are reviewed as part of the DIN application process.
Ongoing Reporting and Licence Maintenance
DEL holders must renew their licence annually by April 1st, report changes through the appropriate amendment process, and maintain records in line with Health Canada’s requirements.
DIN Application
We prepare and manage Drug Identification Number applications for OTC and prescription drug products, covering new applications, amendments, and renewals.
NDS and ANDS Registration
For companies filing New Drug Submissions or Abbreviated New Drug Submissions with Health Canada, we support the full preparation, documentation, and submission process.
Drug Establishment Licence (DEL)
We guide drug companies through the DEL application process, from initial GMP gap assessment through submission, inspection readiness, and annual renewal.
Psychedelics Compliance
For companies pursuing Health Canada-sanctioned therapeutic or research pathways involving controlled substances, we provide regulatory guidance tailored to this specialized framework.
Our team has supported DIN applications and compliance work across a wide range of OTC drug product categories in Canada, including:
Sports Nutrition Products
Sunscreens
Hand Sanitizers
Multivitamins
Super Greens and Health Products
Energy Boost Products
Gummies
Companies fabricating OTC or prescription drug products in Canada that need DEL compliance, GMP gap assessment, and product registration support.
Foreign manufacturers and brand owners looking to import or distribute drug products in Canada, including DEL foreign site annexation, DIN applications, and label compliance for the Canadian market.
CPG and supplement brands whose products cross over into OTC drug territory under Health Canada’s classification framework, requiring DIN registration rather than or in addition to NPN licensing.
Canadian importers and distributors who need a DEL to bring drug products into the country and require ongoing compliance support to maintain their licence in good standing.
Organizations working within Health Canada-sanctioned controlled substances frameworks, including psychedelic-assisted therapy research programs requiring regulatory support and licence management.
Beyond OTC drugs, the OTC Drugs & Controlled Substances section also covers organizations working under Canada’s Controlled Drugs and Substances Act (CDSA). The CDSA governs the possession, production, distribution, import, and export of scheduled substances, from pharmaceutical narcotics to psilocybin and MDMA. Any organization conducting activities with these substances needs a Dealer’s Licence or Section 56 exemption from Health Canada before those activities can legally begin.
For organizations working specifically in the psychedelics space, including psilocybin research programs, MDMA clinical trials, and approved therapeutic applications, we provide dedicated licensing and compliance support under the CDSA.
The latest on DIN applications, DEL requirements, and OTC drug compliance in Canada.
A Drug Identification Number (DIN) is Health Canada’s product-level authorization for a drug sold in Canada. If your product is classified as a drug under the Food and Drugs Act, whether OTC or prescription, it needs a DIN before it can be sold. The key question is whether your product falls under the drug definition, which turns on its ingredients, the claims you are making, and how it is presented to consumers. Some products that are sold as supplements in the US are classified as drugs in Canada, which means they need a DIN rather than an NPN. We can help you determine which pathway applies before you invest in the wrong registration.
A Drug Identification Number (DIN) applies to drugs regulated under the Food and Drug Regulations, including most OTC medications, sunscreens, hand sanitizers, and prescription drugs. A Natural Product Number (NPN) applies to natural health products regulated under the Natural Health Products Regulations, such as vitamins, minerals, and herbal remedies. The classification of your product determines which pathway applies, and in some cases the boundary is not obvious. If you are unsure which framework covers your product, this is worth sorting out early.
Not automatically. Canada has its own review process for each product, and Health Canada may have different monograph standards, ingredient restrictions, or acceptable concentration limits than the FDA. Your US label will also not meet Canadian requirements. We review your existing formulation and labelling against Canadian standards and identify what needs to change before you submit a DIN application.
Timelines vary depending on the submission type. OTC products that follow a Health Canada monograph move faster than products requiring a full new drug submission. In general, plan for several months from submission to issuance, and factor in time to prepare a complete application package. Incomplete submissions or those with labelling issues can extend the timeline significantly. We prepare submissions that are complete and well-documented, which reduces back-and-forth with Health Canada reviewers.
Yes. Any company importing drugs into Canada for distribution or sale must hold a Drug Establishment Licence covering the importation activity. Your licence must also list all foreign facilities involved in fabricating, packaging, or testing the products you import. This is a separate requirement from the DIN and applies to the company and its operations, not just the product.
We prepare the full submission package: product monograph review or new drug submission as applicable, formulation documentation, labelling review and bilingual compliance, supporting evidence, and the application filing itself. We verify the submission before it goes to Health Canada, track it through the review process, and respond to any reviewer questions or deficiency notices on your behalf. The goal is a clean, complete submission that moves through review without unnecessary delays.
It depends on the ingredients and the claims. Many gummy products sold as dietary supplements in the US fall under the Natural Health Products Regulations in Canada and require an NPN, not a DIN. However, if your gummies contain drug ingredients, or if the claims you are making go beyond what is permitted under the NHP framework, a DIN may be required. Some products need both. We review the product and the intended claims and tell you exactly which pathway applies before you proceed.
Talk to a specialist about your OTC drug compliance situation. Whether you are working through a DIN application, setting up a DEL, or figuring out which regulatory pathway applies to your product, we can help you map out the right next steps.