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Canadian Laws & Regulations

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1. PURPOSE
2. BACKGROUND
3. SCOPE
4. DEFINITIONS
5. POLICY STATEMENT
6. RESPONSIBILITIES
7. PROCEDURES
8. EFFECTIVE DATE

1. PURPOSE

The purpose of this document is to ensure that the policy and enforcement measures related to the importation of human-use drugs for personal use are uniform throughout the Therapeutic Products Programme.

This directive supersedes any Regional guidance or procedures.

2. BACKGROUND

This directive provides guidance to help officials of Health Canada to confirm that the importation is for personal use and provides a uniform framework for enforcement.

The Food and Drugs Act and Regulations (the Regulations) do not regulate the importation of drugs for personal use unless the drugs sought to be imported arelisted in Schedule F to the Regulations (prescription drugs). The Controlled Drugs and Substances Act regulates the importation of substances or drugs classified as controlled, narcotic or restricted. It has been the policy of the Therapeutic Products Programme (TPP) to permit individuals to import a three-month supply of a drug for their own personal use unless prohibited by law. This policy is comparable to policies in other countries.

Respecting the importation of drugs for personal use, Health Canada is primarily concerned that these importations will not be diverted for commercial purposes. Recent attention has been drawn to commercial importations of drug products that have circumvented regulatory requirements by claiming that these importations were for "personal use." Foreign suppliers, which have commercial sales organizations in Canada, are claiming that individually packaged shipments, which are mailed directly to purchasers, qualify as an importation under the personal use import policy. The personal use exemption unfortunately provides an opportunity for these suppliers to conduct commercial activities, and to evade the submission review process for individual products, and/or the Establishment Licence requirements for importers, by supplying their drug products primarily through the mail to individual Canadians. These activities at times may include violative marketing and advertising activities by means such as the Internet. This has ramifications related to safety because large quantities of products, which have not been reviewed for safety and/or efficacy, and which are of unknown quality, can enter the country and be distributed. The lack of an importer also means no person is responsible for meeting GMP requirements such as appropriate record retention or recall mechanisms.

There is also evidence of patients ordering prescription drugs directly from foreign suppliers as a means of avoiding the higher costs of the same drugs available from Canadian suppliers. This situation results in a competitive disadvantage to domestic companies who are compliant with product and establishment regulations in addition to fee regulations.

3. SCOPE

This directive applies to all drugs in dosage form (including biologics), for human-use only.

4. DEFINITIONS

For the purpose of this directive:

Sell as defined in the Food and Drugs Act includes offer for sale, expose for sale, have in possession for sale, and distribute, whether or not the distribution is made for consideration. Drugs imported into Canada for personal use have not been considered to fall within this definition of sell.

Personal use includes the importation for use by one person, either the importer or another individual member of the importer's immediate family. For the purpose of this clause, immediate family is defined as father, mother, children, or spouse (including a common-law spouse) with whom the importer permanently resides.

5. POLICY

It is the policy of the Therapeutic Products Programme to permit individuals to import a three-month supply of a given drug for their own personal use, once during each quarter of the year. The exceptions to this policy are stipulated by legislation or the Regulations, and include the following:

Prescription Drugs

a) Section C.01.045 of the Regulations restricts the importation of a prescription drug; listed in Schedule F, Part I, or Schedule F Part II which is not for veterinary use; to a practitioner, a drug manufacturer, a wholesale druggist, a registered pharmacist or a resident of a foreign country while a visitor in Canada. However, persons (regardless of residence) coming from abroad will usually be permitted to importenough drug for a single course of treatment or a three-month supply, whichever is the lesser, of a Schedule F drug, if the drug is packaged in pharmacy or hospital dispensed packaging.

Controlled Drugs and Substances Act

b) Subsection 6.(1) of the Controlled Drugs and Substances Act restricts the importation of narcotic, controlled and restricted drugs to licensed dealers who have obtained an importation permit.

Any Drugs FOR SALE

c) Section A.01.040 of the Regulations prohibits the importation for sale of a drug if its sale in Canada constitutes a violation of the Food and Drugs Act and Regulations. Drugs destined for commercial establishments are considered to be imported for sale and therefore personal use exemptions cannot be applied.

Special Access Program

Individuals other than those listed in C.01.045 seeking to import prescription drugs listed in Schedule F to the Regulations for their personal uses are required to contact their physician to obtain a prescription for the medication. Drugs available in Canada should be obtained from a Canadian source. Drugs not available in Canada, (including prescription, controlled drugs, non-prescription drugs, or new drugs which have not yet been classified in any schedules), can be obtained through the emergency drug release provisions of section C.08.010. The Special Access Program (SAP), formerly the Emergency Drug Release Program (EDRP), provides for the release of drugs which are otherwise unavailable for sale in Canada to physicians, dentists and veterinarians. Through SAP, the TPP provides legal access to these drugs; however, it does not endorse their safety or efficacy. Practitioners who use the Program must agree to report on the outcome of the therapy with the drug, including any suspected adverse drug reactions. For drugs regulated by the Controlled Drugs and Substances Act, special permit procedures need to be followed involving the Bureau of Drug Surveillance.

6. RESPONSIBILITIES

The implementation of this directive is the responsibility of staff of the TPP.

7. PROCEDURES

Drugs Accompanying Travellers

When persons (regardless of residence) are coming from abroad, they will usually be permitted to import enough drug for a single course of treatment or a three-month supply, whichever is the lesser, of a prescription drug listed in Schedule F or any other drug which has been prescribed by a physician if it is packaged in pharmacy or hospital dispensed packaging, or of any non-prescription drug. Some discretion may be required in unusual circumstances, e.g., long term visitors to isolated locations, long-term visitors where language or other barriers may impede establishing good communications with a Canadian physician, persons returning from countries which dispense in trade packages.

No person may bring any substance that is regulated by the Controlled Drugs and Substances Act into Canada unless they have obtained an authorization from the Bureau of Drug Surveillance.

Drug Shipments

Where a shipment of a drug is encountered at Canada Customs, a Health Canada official determines:

1. Whether the importer is a legal recipient of the imported drug.

Prescription Drugs

a) Where the shipment contains a drug for human use listed in Schedule F to the Regulations that is not destined to a recipient as listed in C.01.045, it is normally refused entry. In order to not delay or interupt a course of treatment or other situations in which refusal of entry could create a health risk, inspectors may allow entry of an initial 3-month supply of a drug, if the drug is packaged in hospital or pharmacy dispensed packaging. However, the recipient will be informed that all future shipments will be detained and that either a Canadian source should be used or that their physician should obtain a foreign supply through the Special Access Programme for drugs not available in Canada. Please see Appendix A for a copy of a suggested form letter which can be used for this purpose.

Controlled Drugs and Substances

b) Where the shipment contains any narcotic, controlled or restricted drug that is not destined to a licensed dealer who has obtained an importation permit, it is refused entry and further legal action is possible.

All Other Drugs (Usually in Trade Packaging)

2. Whether the importer is importing the drug for commercial purposes.

a) Where the shipment is destined for a retailer, distributor, or other commercial establishment, it will not be considered a personal shipment and A.01.040 will apply.

b) Where the shipment is part of a pattern of repeat personal importations of the same drug to the same individual or address within a three-month period, it is considered to be a commercial shipment and A.01.040 will apply.

c) Where the shipment is part of a larger shipment from a single foreign supplier, which consists of individually addressed parcels, and the importer of record as indicated on a separate customs invoice for each parcel, is not unique for each parcel, the shipment will be considered to be a commercial shipment and A.01.040 will apply. However, if each parcel is uniquely addressed, and if there is a separate invoice for each parcel, then entry is permitted.

d) Where the shipment is accompanied or associated with advertising or promotional material, except for patient information such as directions for use, the importer is considered to be a distributor. The shipment will therefore not be considered to be a personal shipment and A.01.040 will apply.

3. Whether the quantity of the drug which is sought to be imported represents a supply greater than three months of the drug for one individual's use, based on its directions for use or reasonable intake.

a) Where more than a three-month supply of a drug for use by one person is being imported, it is considered to be for sale and it is refused entry.

Available Measures of Enforcement
 

• Refusal of entry or conditional entry at Customs to drug products which are not permitted entry due to conditions as stated in 1. a), b); 2. a), b) c), d); or 3. a) above.
• Request voluntary detention, re-export, or voluntary disposal of drug products.

The first version of this Importation of Human-Use Drugs for Personal Use Enforcement Directive came into effect on January 1, 1998.
 
 
 
 

Appendix A

(HPB Office Address)

Date:

TO:

Dear Sir/Madam:
 

Your shipment has been examined under the provisions of the Food and Drugs Act and found to contain prescription medication. The importation of Schedule F (prescription) drugs is prohibited, except by certain designated persons (e.g., doctors or pharmacists). It is recommended that you contact your doctor to obtain a prescription for this medication which must be filled in Canada. Medications which are not available in Canada can often be obtained through Health Canada's Special Access Programme.

Your physician may contact the Special Access Program [Phone: (613) 941-2108 or Fax: (613) 941-3194] for authorization to obtain these for you.

Future importation of these or other prescription drugs could result in the return of those products to their origin.

If you have any questions or need clarification, please call (###) ###-####.
 
 

(INSPECTOR NAME)
Drug Inspector
(REGION OR DISTRICT)

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