Medicine Import Guidelines Of Canada For Personal Use

Rules for Bringing Life-Saving Medicines into Canada

Bringing medicines that are not approved or available in Canada for personal use can be tricky. Canada has strict rules under a law called the Food and Drugs Act (1985). This guide will help explain what you need to know before importing life-saving medicines.

What Is the Food and Drugs Act (1985)?

The Food and Drugs Act (1985) is a law that makes sure all medicines in Canada are safe and effective. It protects people by stopping unapproved or unsafe medicines from being sold or brought into the country, unless special rules are followed.

Can You Bring Medicines into Canada for Personal Use?

Usually, you are not allowed to bring unapproved medicines into Canada. However, there are a few exceptions when it comes to life-saving medicines.

You may be allowed to bring medicines into Canada if:

• It’s for personal use only (you can’t sell or share it).
• You bring only a small amount, usually enough for 90 days or less.
• The medicine is not available in Canada.
• The medicine is needed to treat a serious or life-threatening illness.

Who Can Import a Health Product for Personal Use?

Residents and visitors in Canada can bring health products into the country for personal use. Here’s what you need to know:

What Can You Bring?

• Over-the-counter medications (OTC)
• Natural Health Products (NHP)
• Veterinary Health Products (VHP)
• Medical Devices

Must be easy to use without professional help. Devices needing assistance are classified as commercial and require special approval.

Import Rules:

You can bring a 90-day supply or a single course of treatment without needing a special license.

Special Restrictions:

Drugs for Food-Producing Animals:

• Must be approved in Canada, listed as a notified VHP, or included on List B: Certain Veterinary Drugs Which May Be Imported But Not Sold.

Prescription Drugs:

• Only practitioners, drug manufacturers, wholesale druggists, registered pharmacists, or foreign visitors can import prescription drugs.
• Canadian residents are not allowed to import prescription drugs by mail or courier, except in certain exemptions.

What Papers Do You Need?

You’ll need to prepare some documents to bring your medicine into Canada.

Prescription from Your Doctor:

• Get a prescription from a licensed Canadian doctor.
• The prescription should explain why you need the medicine for your illness.

Doctor’s Letter:

• Your doctor can write a letter explaining why you need this specific medicine and why other treatments in Canada won’t work.

Medicine Details:

• Bring information about the medicine, such as who made it, what it’s made of, and proof that it’s approved in another country.

What Happens at the Border?

When your medicine arrives in Canada, it will be checked by border officials and Health Canada.

Declare Your Medicine:

• Tell the border officials about the medicine. If you don’t, it might be taken away, and you could face legal trouble.

Inspection:

• Officials will check if your medicine follows the rules. If it doesn’t, they may not allow it into the country.

Government of Canada's Role in Medicine Importation

Health Canada ensures that imported health products follow the rules under the Food and Drugs Act. It works with the Canada Border Services Agency (CBSA) to inspect medicines entering Canada by mail, courier, or in person.

Border Inspections:

• CBSA officers can hold health products that may not follow the rules.
• Health Canada checks if the products meet regulations, which may include testing samples.

Non-Compliant Products:

• Products that don’t meet the rules will be refused entry, seized, or destroyed.
• Importers will be notified in writing about the decision, including any options for handling seized goods.

Avoiding Delays:

• Include all required documents and product details with your shipment.

Costs and Responsibility:

• Importers may have to pay for storage, transport, or disposal of seized goods.
• Health Canada is not liable for financial losses caused by decisions under the Act.
• Following these guidelines helps ensure smooth importation and compliance.

What If the Medicine Isn’t Available in Canada?

If you can’t get the medicine you need in Canada, your doctor can apply for special permission through the Special Access Program (SAP).

How It Works:

• Your doctor sends a request to Health Canada.
• They explain why you need the unapproved medicine and why other treatments won’t work.

If Approved:

• The medicine can be brought into Canada for your use, but only under the care of your doctor.

What Types of Health Products Are Regulated Under the Food and Drugs Act?

Health products in Canada are regulated under the Food and Drugs Act because they are used to treat, prevent, or diagnose diseases or conditions in humans and animals. They are different from cosmetics, which are regulated separately and do not have therapeutic purposes.

Here are the types of health products regulated under the Act:

Prescription Drugs

• For humans and animals (e.g., antibiotics, heartworm medications with ingredients on the Prescription Drug List).

Over-the-Counter Drugs

• For humans and animals (e.g., pain relief tablets, cough medicine, and dewormers with ingredients not on the Prescription Drug List or Controlled Drugs and Substances Act).

Natural Health Products

• For human use (e.g., vitamins, minerals, herbal remedies, and homeopathic medicines).

Veterinary Health Products

• For animals (e.g., joint support products with active or traditional medicine substances on List C).

Medical Devices

• For humans (e.g., thermometers, contact lenses, blood pressure monitors, diabetes test strips, condoms).

Blood and Blood Components

• For human transfusions.

Human Cells, Tissues, and Organs

• For transplantation (e.g., organs and tissues for medical use).

Active Pharmaceutical Ingredients

• For human and animal medications.

Exceptions:

• Sperm and ova used for assisted reproduction are regulated under the Assisted Human Reproduction Act and are not included under the Food and Drugs Act. These may require permits from the Public Health Agency of Canada or the Canadian Food Inspection Agency due to the risks of carrying pathogens.

By regulating these products, Canada ensures the safety, effectiveness, and quality of health products available for human and animal use.

Are There Shipping or Packaging Requirements? 

Yes, health products brought into Canada for personal use must follow these packaging rules:

Packaging Options:

• Be in the package dispensed by the hospital or pharmacy.
• Be in the original retail packaging.
• Have the original label attached (clearly showing what the product is and its contents).

Label Requirements:

• The label must include proper directions for use to help Health Canada confirm the product meets the personal-use limit.
• Proper packaging and labeling are essential to ensure smooth importation and compliance with Canadian regulations.

Can My Doctor or Veterinarian Access Health Products Not Available in Canada?

Yes, your doctor or veterinarian may be able to help you access health products unavailable in Canada through special programs.

For Patients: Special Access Program (SAP)

A Canadian doctor can request access to drugs or medical devices through the SAP if:

• The drug or device is not sold in Canada.
• You have a serious, life-threatening condition and:
• Conventional treatments have failed, been ruled out, or are unsuitable.

For Animals: Emergency Drug Release (EDR)

A Canadian veterinarian can request access to veterinary drugs through the EDR if:

• The drug is not available for sale in Canada.
• It is needed to diagnose or treat a medical emergency in an animal or group of animals under their care.
• These programs are designed to help in urgent or life-threatening situations where no other options are available.

Things to Be Careful About

There are risks and rules you need to keep in mind:

Safety Risks:

• Medicines not approved by Health Canada may not be safe or work as expected.
• Some medicines could be fake or poor quality.

Legal Risks:

• Breaking the rules can lead to your medicine being taken away.
• You could also face fines or other legal trouble.

What Are Your Other Options?

Before trying to bring unapproved medicine into Canada, consider these steps:

• Talk to Your Doctor: Ask about medicines that are already available in Canada.
• Join a Clinical Trial: Some studies let you access experimental medicines.
• Use the Special Access Program (SAP): Your doctor can help you apply for medicines through this program.

Final Thoughts

Bringing unapproved medicines into Canada is not easy, and there are strict rules to follow. Make sure you have all the required documents and work with your doctor. It’s also a good idea to check with Health Canada for guidance before taking any steps.

By following these rules, you can avoid problems and safely access the medicine you need.

Sources

Food and Drugs Act (1985) 

Health Canada: Importing Prescription Drugs for Personal Use

Health Canada: Special Access Program - Drugs 

Assistance with Importing TGA-Approved Medicines into Canada

If you’re looking to import a medicine approved by the Therapeutic Goods Administration (TGA) that isn’t yet available in Canada, our Patient Support Team is here to help. We'll guide you step-by-step through the import process to ensure you get the medication you need.