Importing pharmaceutical products into Canada involves navigating a complex regulatory landscape. Health Canada, the federal authority responsible for drug safety and efficacy, requires importers and manufacturers to submit specific applications depending on the type of drug, its intended use, and its market status. In this post, we’ll break down the main submission types you need to know when importing pharmaceuticals into Canada.
Drug Establishment Licence (DEL)
Before marketing your drugs in Canada, foreign companies must first obtain an importer with a Drug Establishment Licence (DEL). This is one of the most critical requirements for any foreign business engaged in having their pharmaceutical products imported into Canada.
Why it matters:
The DEL ensures the importer establishment, and all the foreign sites associated with the manufacture, packaging, labelling, and testing of the finished dosage form and the active pharmaceutical ingredients comply with Good Manufacturing Practices (GMP) as outlined in Part C, Division 2 of the Food and Drug Regulations. Without an importer with a DEL, Canada Border Services Agency will not release pharmaceutical shipments into Canada.
Drug Identification Number (DIN) Submission
For any drug to be sold on the Canadian market, it must have a Drug Identification Number (DIN). This eight-digit number confirms that the product has been evaluated and approved by Health Canada for safety, efficacy, and quality.
When to apply:
- If you are going to market a finished pharmaceutical product in Canada
What’s included in the submission:
- Product formulation
- Manufacturing site details
- Labelling
- Safety data
This submission is required for non-prescription, prescription, and over-the-counter drugs that are not classified as new drugs under Canadian law.
New Drug Submission (NDS)
When a drug qualifies as “new” under Canadian regulations—either due to a new active ingredient, indication, dosage form, or route of administration—it must go through the New Drug Submission (NDS) process.
Applicable for:
- Brand-new drugs never before sold in Canada
- Major changes to an existing drug’s formulation or indication
What’s required:
- Comprehensive clinical trial data
- Non-clinical pharmacology and toxicology data
- Chemistry and manufacturing information
- Product labelling and packaging details
An NDS is a time-intensive process but essential for gaining market authorization of innovative therapies.
Abbreviated New Drug Submission (ANDS)
Generic drug manufacturers follow a streamlined version of the NDS called the Abbreviated New Drug Submission (ANDS).
When used:
- To demonstrate that a generic drug is bioequivalent to an already approved Canadian reference product.
Key requirements:
- Bioequivalence studies
- Comparative labelling
- Chemistry and manufacturing data
Clinical trial data is not usually needed unless equivalence is in doubt. This submission enables cost-effective alternatives to enter the market efficiently.
Clinical Trial Application (CTA)
If a company wishes to import a drug for research purposes within a clinical trial setting, a Clinical Trial Application (CTA) must be submitted.
Purpose:
- To gain approval for the importation and use of an investigational drug in human trials in Canada.
Needed for:
- Sponsors of Phase I, II, or III clinical trials
- Drugs not yet approved for sale in Canada
- Contents include:
- Investigator’s Brochure
- Clinical trial protocol
- GMP documentation
- Informed consent forms
Approval must be granted by Health Canada before the product can be used in Canadian subjects.
Special Access Program (SAP)
The Special Access Program (SAP) allows practitioners to import unauthorized drugs for individual patients with serious or life-threatening conditions when no alternatives are available.
How it works:
- Healthcare practitioners submit a request on a per-patient basis, or in some instances, product can be pre-positioned in Canada for Healthcare practitioner request.
- Health Canada reviews the clinical justification.
- If approved, importation is allowed under restricted conditions.
SAP is not for commercial supply, clinical trials, or stockpiling. It is a compassionate use pathway meant to prioritize urgent patient needs.
Interim Order Pathways
During public health emergencies, Health Canada may issue Interim Orders to temporarily authorize the importation of unapproved drugs.
Used in:
- Pandemics (e.g., COVID-19)
- National emergencies
Benefits:
- Fast-tracked access
- Temporary regulatory flexibilities
- Streamlined import protocols
These orders are time-limited and typically come with strict reporting and compliance requirements.
Post-Authorization Submissions
Even after a drug is approved and imported, companies may need to submit updates or changes to Health Canada. These fall under the post-authorization submission category.
Common types:
- Supplemental New Drug Submissions (SNDS): For significant changes such as new indications or dosage forms.
- Notifiable Changes (NC): For moderate changes like minor manufacturing updates.
- Labelling-only Submissions: For changes in text, layout, or warnings on the label.
Each type must meet specific data requirements and is assessed by Health Canada before implementation.
Final Thoughts
Importing pharmaceutical products into Canada requires careful regulatory planning and compliance with Health Canada’s submission requirements. Whether you’re registering a new product, importing for a clinical trial, or seeking emergency access, selecting the right submission type is key to successful market entry.
Need Help Navigating the Process?
At Progress Therapeutics, we specialize in importing healthcare products into Canada—including pharmaceuticals, APIs, medical devices, and investigational drugs. Our services cover everything from regulatory strategy and DEL applications to customs clearance and pharmacovigilance assistance.
Let’s simplify your importation process. Contact us to learn how we can support your product’s journey to the Canadian market.