What You Need to Know About Medicine for Human Use and International Borders

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Table of Contents:

What is the mandate of the Health Products and Food Branch Inspectorate?

Which Medications are covered by this Guidance Document?

I'm travelling outside Canada. What should I do about my prescription drugs?

What is considered "proof of need" for prescription medication?

What quantity of prescription drugs can I take with me outside Canada?

I am returning to Canada with a prescription drug not available in Canada. What can I do?

What about returning to Canada with over-the-counter drugs?

Can medicines be shipped to me from outside Canada?

What are the requirements for importing medications for personal use into Canada?

Are there any restrictions on importing medications ordered from a foreign website?

Contact us for further information:

Health Products and Food Branch Inspectorate - Operational Centres

Where can I obtain additional information about health products?

Appendix 1: Requirements for Personal Importation

Appendix 2: Examples of Product and Package Sizes

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What is the mandate of the Health Products and Food Branch Inspectorate?

Health Canada's mission is to help the people of Canada maintain and improve their health. The Health Products and Food Branch Inspectorate (HPFBI) works in partnership with the Canada Border Services Agency (CBSA) to enforce the Acts and the regulations administered by Health Canada to prevent the importation for sale of violative or dangerous medications into Canada. Export of medicines from Canada, when you are travelling to other countries or sending medicines to friends or relatives, will be regulated by the countries into which the medicine is being imported.

Which Medications are covered by this Guidance Document?

Medications defined as "drugs" or "natural health products" (NHPs), and their importation to Canada, are regulated in the Food and Drugs Act or the Controlled Drugs and Substances Act and related regulations. Depending on the type, method of importation and amounts of medications being imported, there may be restrictions on their importation and therefore refusal of entry at the Canadian border. This guidance document does not apply to the importation of drugs for use in animals.

I'm travelling outside Canada. What should I do about my prescription drugs?

Canadian law does not apply outside Canada. When you are travelling outside Canada with prescription medication, you should carry proof of need. Prescription medication should be packaged in hospital or pharmacy dispensed packaging. This will help ensure that you are always considered in legal possession of your required medicine. There are some medications allowed for use in Canada which would be illegal for import and use in other countries. To be sure that your possession of a prescribed medication is allowed in another country, please contact the embassy of the country that you will be visiting before your departure. For further information and a list of embassies and/or high commissions in Canada, please refer to the websites listed at the end of this guide.

What is considered "proof of need" for prescription medication?

Proof of need includes a copy of the prescription, proper identification on the pharmacy label indicating the contents, dosage, and where possible a note of explanation from your doctor. This information is essential especially if your medication is lost, stolen or when you are travelling to a country that is particularly sensitive about drugs.

What quantity of prescription drugs can I take with me outside Canada?

The HPFBI advises carrying sufficient quantities of a prescription medication for the length of your stay. When travelling, you should always keep your medicine in an easily accessible place, such as carry on luggage if you are flying. Keep in mind that there may be some restrictions on substances allowed as carry on luggage when you fly; check with your airline before packing your bags. Also, remember to follow the storage information shown on the prescription. For instance, some medicine must remain refrigerated. Your pharmacist or doctor can guide you on how to best store your medicine when travelling. Before you go, check with your travel agent or the consulate of the country you will be visiting that you can legally import the medication, in the required amount, to your destination.

I am returning to Canada with a prescription drug not available in Canada. What can I do?

With few exceptions, the importation of prescription drugs into Canada by individuals is not permitted. However, Canadians returning from abroad bringing, on their person, the lesser of a single course of treatment or a 90-day supply of a prescription medication containing a substance listed in Schedule F of the Food and Drug Regulations will not be prevented from doing so. Canadians may also be permitted to import, on their person, the lesser of a 30-day supply or a single course of treatment of a prescription medicine which is a narcotic or controlled drug specified in the section 56 class exemption to the Controlled Drugs and Substance Act. See Appendix 1 for details on Schedule F ingredients and exempted narcotics and controlled substances. This medicine must be for your own personal use or for the use of a person for whom you are responsible and who is travelling with you, and must be in hospital or pharmacy dispensed packaging. Upon your return you should inform your own doctor about the prescribed treatment.

What about returning to Canada with over-the-counter drugs?

It is recommended that you bring no more than a 90-day supply of over-the-counter drugs for your personal use or for a person under your care or guardianship and who is travelling with you. A quantity more than a 90-day supply may be considered "for sale" and subject to scrutiny by Inspectors at the border. Domestically, NHPs such as vitamins, minerals, herbal products and homeopathic products are sold as over-the-counter drugs. Remember that an over-the-counter drug or "dietary supplement" in another country may be a prescription drug in Canada and would be treated as such.

Can medicines be shipped to me from outside Canada?

Shipment of prescription medications to individuals is not allowed (see Appendix 1 for details). Prescription medications shipped through the mail or courier will result in the package being stopped at customs and held, or returned to sender, or even destroyed. Persons (such as residents of foreign countries who are visiting Canada) who may be legally entitled to import personal quantities of prescription drugs should contact the Inspectorate when they receive a notice of examination saying that a shipment was refused entry. Non-prescription medications may be allowed to be imported for personal use, but consumers are encouraged to buy drugs and natural health products which have received marketing authorization from Health Canada, such that their safety and efficacy has been reviewed. Drugs which have marketing authorization are identified by a Drug Identification Number (DIN) on their labels. Natural health products are identified by Natural Product Numbers (NPNs) and homeopathic medicines by Homeopathic Medicine Numbers (DIN-HMs). The Special Access Programme (SAP) provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologics, and radio-pharmaceutical products not approved for sale in Canada. Refer to the web link at the end of the document text for information about the Special Access Programme.

What are the requirements for importing medications for personal use into Canada?

The requirements are different depending on how you are importing the medication and what the purpose of the importation will be. In general, the requirements are as follows:

• you must be importing for your own personal use or the use of another individual in care or guardianship
• you must not be importing for further sale or distribution
• you should limit your importation to certain amounts, based on the direction for use or reasonable intake, depending on the type of medication
• you must import certain medications only in person, not by courier or by mail, and
• where possible, if you are importing a prescription drug, you should present the medication in its original packaging and with evidence that it was obtained through the care of a physician.

See Appendix 1 and 2 for details and examples of limited amounts.

Are there any restrictions on importing medications ordered from a foreign website?

The requirements for importing medications from a foreign website are the same as mentioned above.

Please note that Health Canada is concerned about the quality of products sold online. The safety and effectiveness of these products may be in question, particularly if the product has not received Health Canada authorization. The absence of a marketing authorization is a risk to health and safety. Market authorization may be in the form of a Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) and demonstrates that the health product has been assessed by Health Canada. These numbers consist of eight digits that indicate that a product has been reviewed by Health Canada and found to have an acceptable risk/benefit profile for the conditions for which it was approved. Health Canada also conducts post-market activities for these products including the monitoring of adverse reactions and complaints regarding quality.

Ordering drugs online without professional medical advice and monitoring can pose a number of risks:

1. the inappropriate use of medications
2. the lack of monitoring of harmful side effects. This concern is heightened where products have a narrow range of safety and/or efficacy;
3. the interaction of product with other medicines and/or food products, which could increase their toxicity; and
4. the lack of quality standards found in some drug products purchased outside the normal distribution chain of pharmacies and of inspected and licensed manufacturers, importers, distributors, testing laboratories and wholesalers. Again, safety may be compromised.
5. with the increasing concern over the availability of counterfeit products, it is possible for a product to appear to have market authorization even though it is not legally approved for sale on the Canadian market. These products may contain insufficient or no active ingredient, or unlabelled ingredients that could potentially cause serious adverse effects or even death.

Contact us for further information:

Enquiries should be submitted in writing, whenever possible, to the HPFBI at the Operational Centre responsible for your province. Alternatively, you can call the HPFBI toll free number at: 1-800-267-9675.

Health Products and Food Branch Inspectorate - Operational Centres

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Where can I obtain additional information about health products?

The Health Canada's Health Products and Food Branch Inspectorate website at: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php can be consulted for further information. The Inspectorate toll free number is 1-800-267-9675.

For the link to the Policy on Importations of Drugs for Human Use Including Natural Health Products Into Canada (POL-0019) please visit: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/pol_0019_tc-tm-eng.php .

Definitions and legal requirements are detailed in the Food and Drugs Act and the Controlled Drugs and Substances Act and related regulations. Links to these documents can also be found on our website.

Health Canada provides information about drugs on its website at http://hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php.

Health Canada's website at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php can provide further information on natural health products.

Information about the Special Access Programme for drugs for human use is available at: http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php .

A copy of Schedule F can be found at: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/index.html.

The section 56 class exemption for travellers who are importing or exporting prescription drug products containing a narcotic or controlled drug can be found at: http://www.hc-sc.gc.ca/hc-ps/substancontrol/pol/pol-docs/travellers-voyageurs-eng.php.

Diplomat and International Canada provides a list of the embassies and/or high commissions in Ottawa on its website at: http://www.diplomatonline.com/ambassadors&highcommissioners.html .

Foreign Affairs Canada presents a web page at http://www.voyage.gc.ca/main/drugs/medication-en.asp called "Medical Supplies" in their Consular Affairs Information and Assistance for Canadians Abroad site.

Appendix 1: Requirements for Personal Importation

Controlled substances (narcotic and controlled drugs and targeted substances) and class A precursors may not be imported by mail or courier without an import permit and a controlled substance licence.

Narcotic and controlled drugs (such as codeine, oxycodone, DHEA, barbiturates, or anabolic steroids) for personal use are allowed to be imported in person when the conditions of the section 56 class exemption to the Controlled Drugs and Substances Act are met, as follows:

• the drug substances are not listed in the Annex I to the exemption (except when approved for sale in Canada, or in the country from where they are being exported)
• the amount is the lesser of a 30-day supply or a single course of treatment,
• the drugs have been prescribed by a practitioner in order to meet the medical needs of the person named in the prescription, and are in hospital or pharmacy dispensed packaging with the appropriate labelling,
• you are carrying the drugs on your person and they are for your own personal use, or for a person for whom you are responsible and is travelling with you, and
• you declare the drugs to CBSA at the time of import.

Targeted substances, including benzodiazepines (such as diazepam), are allowed to be imported in person by a Canadian resident when:

• the amount is the lesser of either a 90-day personal supply or a single course of treatment,
• the drugs have been prescribed and are in hospital or pharmacy dispensed packaging with the appropriate labelling,
• you are carrying the drugs on your person and they are for your own personal use, or for a person for whom you are responsible and is travelling with you, and
• you declare the drugs to CBSA at the time of import.

Targeted substances, including benzodiazepines (such as diazepam), are allowed to be imported in person by a resident of a foreign country when:

• the amount is either a 90-day personal supply, the content of the container, or the usual daily dose multiplied by the number of days the person will stay in Canada (whichever is the lesser amount),
• the drugs have been prescribed and are in hospital or pharmacy dispensed packaging with the appropriate labelling,
• you are carrying the drugs on your person and they are for your own personal use, or for a person for whom you are responsible and is travelling with you, and
• you declare the drugs to CBSA at the time of import.

Class A precursors (such as ephedrine or pseudoephedrine) are allowed to be imported in person when:

• the preparation or mixture is intended to treat a medical condition of the individual or an accompanying person for whom the individual is responsible,
• in the case of ephedra, ephedrine or pseudoephedrine, the preparation or mixture is packaged and labelled as a consumer product and the total quantity imported of the precursor contained in the preparation or mixture does not exceed:
  1. in the case of ephedra, 20 g (20,000 mg)
  2. in the case of ephedrine, 0.4 g (400 mg)
  3. in the case of pseudoephedrine, 3 g ; (3000 mg),
• in the case of a preparation or mixture containing ergometrine or ergotamine, it must also be packaged in a container with a label showing that it was dispensed under prescription in a pharmacy or hospital or by a physician and the total quantity imported of the precursor contained in the preparation or mixture does not exceed:
  1. a single prescribed course of treatment, and
  2. a 90-day supply, based on the normal daily dose of the precursor.

Drugs for personal use which are listed in the Schedule F to the Food and Drug Regulations are allowed to be imported by mail, by courier, or in person when:

• you are a resident of a foreign country who is visiting in Canada
• you are a practitioner, and the importation is not for treating your patients, or
• you are a wholesale druggist, a drug manufacturer, or a registered pharmacist, and
• the quantity of the drugs is consistent with personal use.

So as not to interrupt a course of treatment, you may be allowed to import, on your person, drugs listed in Schedule F to the Food and Drug Regulations when:

• you are a Canadian resident returning from abroad,
• the amount is the lesser of a 90-day supply or a single course of treatment,
• the drugs have been prescribed and are in hospital or pharmacy dispensed packaging with the appropriate labelling, and
• you are carrying the drugs on your person and they are for your own personal use, or for a person for whom you are responsible and is travelling with you

Health Canada may allow drugs used in a clinical trial to be imported by mail, by courier, or in person, when:

• the trial you are enrolled in is not sponsored in Canada, or
• you have evidence that you are enrolled in a foreign (i.e. outside of Canada) clinical trial or are under the care of a licensed and practising physician/dentist, and
• you are not importing narcotic and controlled substances by mail or courier.

Drugs, including natural health products (NHPs), other than controlled substances, Class A precursors, or substances listed in Schedule F, may be imported by mail, by courier, or in person when:

• you are importing a 90-day supply, repeated once every 90 days, and
• you are importing for your own use, or for the use of a person under your care or guardianship.

Bulk raw materials used as dosage forms, other than controlled substances, Class A precursors, or Schedule F drugs, may be imported by mail or in person when:

• the shipment contains directions for use which are comparable to normally sold dosage forms,
• you are importing a 90-day supply, repeated once every 90 days, and
• you are importing for your own use, or for a person under your care or guardianship.

Appendix 2: Examples of Product and Package Sizes

Ephedrine: The maximum amount which may be imported in person is 400 mg or 0.4 gram. A bottle containing 100 tablets which are 10 mg each of ephedrine would total 1000 mg or 1 gram and would not be allowed.

Ephedra: The maximum amount which may be imported in person is 20,000 mg or 20 gram. A bottle containing 100 tablets which are 25 mg each of ephedra would total 2500 mg or 2.5 gram and would be allowed unless considered to be more than a 90-day supply.

Pseudoephedrine: The maximum amount which may be imported in person is 3000 mg or 3.0 gram. A bottle containing 20 tablets which are 120 mg each of pseudoephedrine would total 2400 mg or 2.4 gram and would be allowed.

Folic Acid: The daily dosage limit as a non-prescription drug is 1 mg per tablet. A bottle containing 50 tablets which are 2 mg would not be allowed. A bottle containing 50 tablets which are 1 mg each would be allowed.

Ibuprofen: The oral dosage limit as a non-prescription drug is 400 mg per tablet. A bottle containing 20 tablets which are 400 mg each would be allowed.

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