Basic information
Outline of the system
The importation of controlled substances, precursor chemicals, cannabis and industrial hemp is governed by regulations made under the Controlled Drugs and Substances Act (CDSA), which was enacted in 1996 and came into force in 1997, and the Cannabis Act (CA), which came into force on 17 October 2018. The CDSA and CA are the means by which Canada fulfils its obligations under the United Nations (UN) Single Convention on Narcotic Drugs, 1961, Convention on Psychotropic Substances, 1971, and Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (collectively known as the UN Drug Control Conventions).
The CDSA and CA establish a legislative framework that prohibits any person from conducting activities, e.g., importation, exportation, production, distribution with controlled substances, precursor chemicals and cannabis unless authorized by the legislation, regulation, or an exemption issued by the Canadian Minister of Health. The regulations made under the CDSA and CA set out the circumstances under which activities with controlled substances, precursor chemicals and cannabis are permitted.
The substances regulated under the CDSA are grouped into six Schedules (Schedules I to VI) to the Act. Schedules I to IV list-controlled substances (including analgesics, stimulants, sedatives, hallucinogens and anabolic steroids) while Schedule VI lists precursor chemicals. Schedule V lists items which the Minister of Health decides to control on a temporary basis (up to one year with the possible extension for another year) in response to significant risk to public health and safety. Currently there is no item listed in this Schedule. Schedule IX lists the designated devices that are required to be registered with Health Canada before being imported into Canada.
The following sections outline provisions pertaining to the legal import of controlled substances, precursor chemicals and cannabis:
"Controlled Substances"
- Benzodiazepines and Other Targeted Substances Regulations (targeted substances): Sets out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct any activities authorized by these Regulations, including possession, sale, distribution, importing and exporting, and production of targeted substances. The term "targeted substances" refers to any controlled substance listed in Schedule 1 to these Regulations, including benzodiazepines and other psychoactive substances.
- Narcotic Control Regulations (narcotics): Sets out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct any activities authorized by these Regulations, including possession, sale, distribution, importing and exporting, and production of narcotics. The term "narcotic" refers to any controlled substance listed in the Schedule to these Regulations referred to as "narcotics", such as cocaine, opium, codeine and morphine.
- Part G of the Food and Drug Regulations (controlled drugs): Sets out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners, and hospitals may conduct any activities authorized by these Regulations, including possession, sale, distribution, importing, exporting, and production of controlled drugs. The term "controlled drug" refers to any controlled substance listed in the Schedule to Part G of these Regulations, such as stimulants, sedatives, and anabolic steroids.
- Part J of the Food and Drug Regulations (restricted drugs): Governs the activities of producers, distributors, importers, exporters, and research institutions including possession, sale, distribution, importing, exporting, and production of "restricted drugs". The term "restricted drug" refers to any controlled substance listed in the Schedule to Part J of these Regulations, such as MDMA, LSD, and psilocybin. These substances have no approved medical applications and can be used only for scientific and research purposes.
"Precursor Chemicals"
- Precursor Control Regulations: Sets out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners, and hospitals may conduct, any activities authorized by these Regulations, including production, sale/provision, importation and exportation of two broad classes of chemicals listed in Parts 1 and 2 of Schedule VI to the CDSA:
- Class A precursors, such as ephedrine, pseudoephedrine, piperidine, and red/white phosphorus; and
- Class B precursors, such as acetone, hydrochloric acid, and toluene.
While these regulations govern the import of controlled substances and precursors, they may be referred to as two different "licensing/permit systems" – as procedures vary somewhat between the classes of substances – overall, the "systems" are very similar. In this regard, unless otherwise specified in the text below, procedures are the same for each type of substance.
"Designated Devices" Registry: Importation of Pill Presses and Encapsulators
The control mechanism for designated devices is set out in the Controlled Drugs and Substances Act.
Definition of Designated Devices:
Pill press: Manual, semi-automatic or fully automatic device that may be used to compact or mould powdered, granular or semi-solid material to produce coherent solid tablets.
Encapsulator: Manual, semi-automatic or fully automatic device that may be used to fill capsules with any powdered, granular, semi-solid or liquid material.
Designated devices may be used for legitimate purposes in the pharmaceutical, food and consumer products industries. As of 18 May 2017, any individual or business who wishes to import a designated device into Canada is required to register with Health Canada. Legitimate users are required to provide the registration number and proof/confirmation of the registration at the border upon importation of the designated device. Registration is not onerous; the burden on legitimate manufacturers is limited. Failure to register a designated device before importing it across the Canadian border is in violation of the Controlled Drugs and Substances Act. Subsequently, Customs officers may notify Health Canada and/or law enforcement when the device arrives at the border. Border officials, at their discretion, may verify registration with Health Canada.
Health Canada aims to process completed application forms within 15 business days. Incomplete forms will be returned to the applicant and delay the registration process. Health Canada encourages applicants to ensure that the application for registration is complete and submitted in good time.
Each designated device must be registered using a separate application form and is valid for one importation. Once the registration has been processed by Health Canada, applicants will be provided with the registration number for the designated device specified on the form, and a copy of the validated registration form.
"Cannabis"
Cannabis Act: Prohibits the importation or exportation of cannabis and the possession of cannabis for the purpose of exporting it unless otherwise authorized under the CA.
Cannabis Regulations: Sets out the circumstances and requirements in which cultivators, processors, sellers, producers, researchers, laboratories, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct regulated activities with cannabis including possession, sale, distribution, importing and exporting, and production of substances listed in Schedule 1 of the Cannabis Act. Importing and exporting is restricted to cannabis for medical and/or scientific purposes. A holder of a licence is authorized to import or export cannabis for medical or scientific purposes if they also hold an import or export permit.
Cannabis Exemption Regulations (Food and Drugs Act): Cannabis Drug Licence holders seeking to import or export cannabis to be used as an ingredient in health products, or health products containing cannabis in final dosage format, are subject to the requirement to obtain an import or export permit from Health Canada for those activities. This is required for each shipment of cannabis that is imported or exported. The import and export of drugs containing cannabis, or of cannabis to be used as an Active Pharmaceutical Ingredient, must also comply with the requirements of the Food and Drugs Act. The holder of an import or export permit is also authorized to possess, transfer, transport, send, or deliver, or in the case of export, sell, the shipment of cannabis to the extent necessary for the import or export. The permit is issued by the Minister of Health and has a specific validity period. The Section 56 Class Exemption For Travelers Who Are Importing or Exporting Prescription Drug Products Containing a Narcotic or a Controlled Drug authorizes the personal import and export of prescription drugs containing cannabis (such as Sativex) under certain conditions.
Industrial Hemp Regulations: Sets out the circumstances and requirements in which cultivators, sellers, importers and exporters, may conduct regulated activities with industrial hemp (cannabis plants containing less than 0.3% THC) including possession, sale, importing and exporting, and production of hemp derivatives.
Product coverage
Prospective importers of controlled substances, precursor chemicals or cannabis must be authorized under the respective regulations to conduct importation of specific substances. With the exception of Class B precursor chemicals, an authorized importer must apply for an import permit for each individual shipment. The application must specify the supplier's name, address and country, the quantity and type of substances being imported as well as the method of transport and the Customs port of entry. Import permits are valid for one shipment only.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The import permit system is intended to ensure the legitimate trade in controlled substances, precursor chemicals and cannabis for medical or scientific purposes, and minimize the risk of those substances being diverted to illicit markets by monitoring internationally the movement of shipments of these substances, taking into consideration, among other things, annual national estimates for controlled substances submitted by Canada to the International Narcotics Control Board (INCB). The Canadian regulatory system is required to have an import control component to it under the UN Drug Control Conventions.
Questions for products under restriction as to the quantity or value of imports
Please see Answers 6.1-6.11.
The system applies to products originating from which country?
The system applies to controlled substances, precursor chemicals and cannabis from all countries. While there is no actual restriction on which countries these substances can be imported from, substances are rarely imported from countries that are not party to the UN Drug Control Conventions. However, not all substances that are controlled in Canada are controlled in all other jurisdictions (e.g., analogues, salts or derivatives of certain controlled substances, anabolic steroids, etc.).
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
See reply to Question 1
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
For controlled substances, Class A precursor chemicals and cannabis, eligibility to apply for import permits is limited to individuals or companies licensed to import these substances in Canada. While businesses that import Class B precursors must be registered with Health Canada, import permits are not required for individual shipments of those substances.
Is there a registration fee?
There is no fee attached to import permits, with the exception of import permits for cannabis (see below). However, a fee and other requirements may apply to obtain the licence to conduct regulated activities with controlled substances domestically. There is no fee for a Class A precursor licence or a Class B precursor registration.
For cannabis, individuals or companies who import cannabis through their cultivation, processing or medical sale licence must pay a fee of $637 per import permit. Individuals who import cannabis through their research licence, analytical testing licence or cannabis drug licence are not required to pay a fee.
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
For controlled substances, Class A precursors and cannabis, applicants must provide in the import permit application form the name and quantity of substances, the address of the importer and exporter, mode of transport, port of entry, proposed date of entry and the name of transit/transhipment country.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Not applicable.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Not applicable.
Issuing the license
Can a licence be granted immediately on request?
Not applicable.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Not applicable.
Which administrative body is responsible for approving application of licences?
Not applicable.
Must the applications be passed on to other organs for visa, note or approval?
Not applicable.
Are there any other conditions attached to the issue of a licence?
Special conditions may be added on a case-by-case basis
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There are fees to import cannabis.
What is the amount of the fee or charge?
Individuals or companies who import cannabis through their cultivation, processing or sale licence must pay a fee of $637 per import permit. Individuals who import cannabis through their research licence, analytical testing licence or cannabis drug licence are not required to pay a fee.
Is there any deposit or advance payment required associated with the issue of licences?
No.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Generally, an application for an import permit for a controlled substance or class A precursor will be refused if the applicant does not hold a dealer's licence for the substance that is to be imported or holds a dealer's licence that will expire before the date of importation. If the application is for cannabis, the import permit will be refused if the applicant does not hold a licence to conduct activities with cannabis or it will expire before the date of importation, if the applicant has provided false or misleading information in the application, or if there are reasonable grounds to believe the importation would contravene the laws of the country of export or any country of transit/transhipment.
Are the reasons for any refusal given to applicants?
This information is clearly provided to the applicant
Have applicants a right of appeal in the event of refusal to issue a licence?
Yes, the applicant is given a right to appeal, as is listed in the above Regulations.
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
Not applicable.
What documents are required upon actual importation?
Canadian import permits.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Currently, import permits for controlled substances and precursor chemicals are valid for maximum six months from the date of issuance or until the expiry date of the licence whichever is earlier. For cannabis, import permits are valid for six months or until the expiry date of the licence, and may cover two calendar years.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
No.
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?
The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)
Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Allocations of quotas for narcotic drugs and psychotropic substances are published by the United Nations, and this information is provided to dealers upon request and is available on the INCB website. Any nation exporting controlled substances or cannabis may obtain information on Canadian quotas through the INCB. Canada does not allocate a specific quantity to any foreign country or domestic importer.
Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?
The quotas for narcotic drugs and psychotropic substances are allocated annually in accordance with the requirements of the INCB.
Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)
Permits to import controlled substances and Class A precursor chemicals are only issued to dealers who are licensed to import and conduct other activities with the relevant substances, while permits to import cannabis are only issued on a per-shipment basis to licence holders who are licensed to conduct activities with cannabis. All licence holders are required to report to Health Canada on the endorsed quantity imported for each shipment that has taken place. Unused portions of permits for these substances and quantities from cancelled permits are credited back to the quota for the current year. The names of licensed importers are not published for confidentiality and security reasons. Health Canada sends three copies of the permit to the applicant, and it is the applicant's responsibility to send copies of import permits to the exporting country and the customs broker.
From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
All quotas are established on an annual basis, and an application amendment to this quota may be made at any time during the year. Import permit applications are accepted year round. Quotas submitted to the INCB are annual estimates of controlled substances and cannabis for legitimate medical or scientific needs in Canada. When necessary, Canada may amend the estimates by submitting supplementary estimates to the INCB. Additionally, Canada provides the INCB with quarterly statistical reports of narcotic drug imports and exports (Form A).
What are the minimum and maximum lengths of time for processing applications?
Import permits are usually issued within forty-five calendar days of receipt of the application.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Import permits are issued for immediate importation. Currently, permits for controlled substances and precursor chemicals are valid for six months from the date of issue or until the expiry date of the licence, whichever is earlier. For cannabis, import permits are valid for six months or until the expiry date of the licence, and may cover two calendar years. The date when the shipment is imported and the date when the export permit is revoked by the competent authority of the country of export are also considered in setting the permit expiry date.
Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
All applications for import permits are reviewed by the Office of Controlled Substances, with the exception of applications for cannabis, which are reviewed by the Office of Medical Access and Specialized Authorizations.
If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Import permits are issued on a first-come, first-serve basis, provided that the applicant submits a complete application. There is no maximum amount allocated per applicant. Applications are examined for accuracy on receipt. In addition, applications made by forensic, coroner's office and other law enforcement agencies for reference standards are processed as priorities.
In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
In accordance with the UN Drug Control Conventions, a shipment of narcotic drug, psychotropic substances or precursor must be authorized by both the importing and exporting countries.
In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Not applicable.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No.