What does "approved by Health Canada" mean?
Educational information, not medical, legal or insurance advice.
The short answer
It means Health Canada reviewed the drug before it could be sold in Canada, and found that it meets the safety, efficacy and quality requirements of the Food and Drugs Act. It is a statement about the drug. It is not a statement about price.
How Health Canada reviews a drug
When a manufacturer wants to sell a prescription drug in Canada, Health Canada first reviews the drug. Scientists in the Health Products and Food Branch carry out the review, sometimes with outside experts. They look at the safety, efficacy and quality of the drug.
A drug that passes the review is issued a Notice of Compliance. It is also given a Drug Identification Number, or DIN. Health Canada says the DIN indicates the drug's official approval in Canada.
Generic drugs need approval too
Health Canada states that a generic drug must be approved by Health Canada before it can be sold. A generic version is not exempt from review.
Review does not stop at the pharmacy door
Once a drug is on the market, regulatory controls continue. Health Canada does market surveillance, monitors reports of adverse reactions, and handles complaints and recalls.
Who can sell prescription drugs
In Canada, prescription drugs can only be sold to the public by pharmacists, veterinarians or commercial feed mills, and only on a prescription from a practitioner. Which providers count as practitioners depends on the province or territory.
The licensing of pharmacies and pharmacists is under the jurisdiction of the provinces and territories. Their pharmacy regulatory authorities are members of the National Association of Pharmacy Regulatory Authorities.
What approval does and does not tell you
Approval means a drug can be sold in Canada. It does not mean the drug is right for every person. Your doctor or pharmacist can help you decide whether a medicine fits your health needs and your other medications. Please talk to your doctor before you change or stop any medicine.
Approval also does not tell you what a drug costs. Prices are handled separately, through a federal review of patented medicine prices and through provincial and territorial drug plans.
A valid prescription is always required
Health Canada lists, as a sign of a legitimate online pharmacy, that it requires a valid prescription from a health practitioner licensed to practice in Canada. At RxPriceLink, a valid prescription is always required too. We never ask you to upload prescriptions or health records on this website.
What this article does not say
This article explains Health Canada's review only. It does not compare that process with the rules of any other country. For price differences, see why drugs cost less in Canada. For Medicare costs, see how drugs from Canada fit with your deductible.
What it means at RxPriceLink
When we say a medication is approved by Health Canada, we mean it has been reviewed and approved by Health Canada as described above.
RxPriceLink is a referral service, not a pharmacy. We point you toward licensed partner pharmacies and show you the lowest price we find. A valid prescription is always required, and you decide what is right for you.
Keep reading
Local information for each state: Arizona · Florida · New York · Pennsylvania · Texas.
Sources
- Health Canada: How drugs are reviewed in Canada
- Health Canada: Prescription drugs in Canada (safety, efficacy and quality requirements)
- Health Canada: Access to generic drugs in Canada
- Health Canada: The Prescription Drug List (who can sell prescription drugs)
- Health Canada: Choosing a safe online pharmacy (licensing of pharmacies and pharmacists, valid prescription)