Supplying Medicines and Supplements to Canada

Canada asks for two things: a Health Canada authorisation for the product, and a Canadian importer with a Drug Establishment Licence that lists your plant. Every medicine carries a DIN, and new drugs and generics also need a Notice of Compliance. Since July 2026, Canada relies on some foreign decisions, though only for a short list of medicines and not yet for generics.

For buyers, Canada is a well-regulated source of reference products, APIs filed under its own master file system, and GMP-licensed plants. Health Canada issues certificates of pharmaceutical product and GMP certificates for exports. One rule shapes every purchase: medicines meant for Canadians can't be exported if that could cause or worsen a shortage at home.

Canada at a glance

How to supply medicines to Canada

1. Get a DIN and Notice of Compliance. Generics file an ANDS with comparative studies, such as bioequivalence, against the Canadian reference product. New drugs and biosimilars file an NDS. Products that follow a labelling standard or a Category IV monograph can use a simpler DIN application. An FDA approval doesn't carry over, so plan a separate filing. Our dossier and registration service can help.
2. Work with a DEL-holding importer. Your Canadian importer holds a Drug Establishment Licence and takes on regulatory responsibility for the product. Each foreign site that makes, packages or tests it goes on that licence with GMP evidence: a certificate under a mutual recognition agreement, or a recent inspection report from a regulator. Our documentation pack helps you gather it.
3. File a Canadian master file for the API. Canada runs its own master file system, where an API master file is Type I, not Type II as in the US. The holder sends Health Canada a letter of access for each applicant, and a US DMF won't carry over. See CEP vs DMF vs ASMF.
4. Plan for pricing and public plans. The PMPRB checks that patented medicine prices aren't excessive, under guidelines in force since 1 January 2026. The pan-Canadian Pharmaceutical Alliance negotiates for public drug plans, and its tiered generic pricing links a new generic's price to the brand. The US and Canada import guide has the detail.

Practitioners can request a medicine that isn't authorised in Canada through the Special Access Program, for a patient with a serious or life-threatening condition; most requests are processed within one working day, and the manufacturer decides whether to supply. In a Tier 3 or other critical shortage, DEL holders can import a foreign-authorised version that Health Canada has listed. See named-patient and special import and government tender supply.

Sourcing from Canada

• Reference products and comparators. Canadian generics are tested against the Canadian reference product, and some trials need it as a comparator. Plan volumes early: since November 2020, licence holders can't sell or export drugs meant for the Canadian market if that could cause or worsen a shortage. Our comparator supply service and comparator sourcing guide cover documents and supply risk.
• APIs and master files. Canadian API makers file a Type I master file with Health Canada and grant letters of access. If you file elsewhere, ask whether the maker also holds a US DMF or a European CEP. See what a DMF is and our API supplier network.
• Contract manufacturing. Canadian plants work under a Drug Establishment Licence and Health Canada GMP rules. Canada has GMP mutual recognition agreements with several partners, including the EU and Switzerland, so check whether one covers the market you are supplying. Start with our CDMO guide or white-label manufacturing.
• Export certificates. Health Canada issues electronic certificates of pharmaceutical product in the WHO format, and separate GMP certificates for drug sites. The applicant must be in Canada and the product needs a valid DIN, with a letter from the DIN owner if someone else applies. Certificates are valid for one year. See how importers use a CoPP.

Supplements

Vitamins, minerals, herbal products, probiotics and similar products are natural health products. Each needs a Health Canada product licence before sale, shown on the label as an eight-digit NPN, and the Canadian sites that make, package, label or import them need a site licence and must follow GMP. Some fortified bars and drinks are supplemented foods under the food rules instead; either way, keep disease claims off the pack. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What people in Canada search for

Semrush data from October 2026 shows that people in Canada search most for creatine (about 90,500 searches a month), ashwagandha and magnesium glycinate (74,000 each), magnesium (60,500) and magnesium bisglycinate (49,500).

Among medicines, Canadians search generic names such as naproxen (about 21,170 searches a month), rosuvastatin (19,090), amlodipine (16,700) and sertraline (14,000), and melatonin gets about 13,500.

How importers, pharmacies and manufacturers in Canada search

Outsourcing terms lead the trade searches: “private label” gets about 590 searches a month and “contract manufacturing” about 480.

Originator brands searched by name include Ozempic (semaglutide). Brand names are trademarks of their owners and are used only to identify the medicine.

Supplements we can help you make

Often searched medicines include semaglutide, naproxen, rosuvastatin, amlodipine and sertraline. Some examples we list:

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our US and Canada import guide.

Frequently asked questions