Importers of OTC Products
Any company importing over-the-counter drugs into Canada must hold an active DEL and comply with GMP requirements.
Companies that manufacture, package, label, import, or test OTC drugs in Canada must hold a valid Drug Establishment License (DEL). Dell Tech prepares and submits DEL applications, renewal packages, and quality documentation to help you maintain Health Canada compliance.
We determine whether your company’s activities require a Drug Establishment License and assess the appropriate license categories.
Dell Tech completes and submits all required application forms, including the FRM-0033 and attestations required by Health Canada.
We assist in implementing the necessary quality systems to satisfy GMP requirements, including SOPs and quality agreements.
Our team monitors regulatory updates, helps prepare for Health Canada inspections, and manages license renewal deadlines to ensure continued compliance.
To obtain and maintain a DEL, companies must:
Failure to meet these requirements can lead to license refusal, suspension, or revocation.
A DEL (Drug Establishment License) authorizes companies to conduct certain drug-related activities (e.g., import, distribute) at a specific Canadian address. A DIN (Drug Identification Number) is assigned to a specific OTC product that has been approved for sale in Canada. Most companies need both.
Yes. We specialize in helping importers and distributors navigate licensing requirements and ensure their operations are fully compliant.
Timelines vary depending on Health Canada’s processing volume and the completeness of your application. Dell Tech helps streamline the process to avoid common delays.
No. The DEL applies to your business operations at the address it is issued to. However, each OTC product must still be registered and assigned a DIN before being sold.
Operating without a required license can result in Health Canada enforcement actions, including warning letters, product seizures, and business closure orders.
Our team has decades of experience helping clients navigate Canada’s drug establishment licensing process. Whether you’re a Canadian startup or a global brand entering the market, Dell Tech ensures you meet all licensing requirements without unnecessary delays.
Contact us for updates on licensing standards, OTC product rules, and Health Canada regulatory alerts.