Basic information
Outline of the system
The importation into Canada of drugs, blood, natural health products and medical devices is subject to establishment or site licensing to ensure that imported substances meet Canadian standards of safety, efficacy and quality. The import of these products is covered by the Food and Drug Regulations, the Blood Regulations, the Natural Health Products Regulations, and Medical Devices Regulations, respectively. In addition to establishment or site licences permitting persons to, among other things, import a health product, product licences or market authorizations are required for the sale of each specific health product in Canada.
In the case of medical devices, a market authorization is required for Class II, III and IV devices, which correspond to mid and high-risk devices. Class I devices, which are the lowest risk, are not issued product-specific market authorizations and are instead covered under establishment licences.
The importation of human cells, tissues and organs (CTO) for transplantation are not subject to licensing, but imported products must meet Canadian standards for safety, as expressed in the respective regulations. Establishments that import and/or distribute CTOs are required to be registered with Health Canada. Any tissue or cell (other than lymphohemapoietic cell) imported into Canada under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations must also have been processed by a registered establishment.
Product coverage
Establishment licences are required for "import for sale" of drugs (including pharmaceuticals, active pharmaceutical ingredients, biologics, vaccines, blood products, and radiopharmeuticals), blood, and medical devices. However, licences may not be required for blood if import is done under urgent circumstances.
Site licences are required for "import for sale" of natural health products (including vitamins and minerals; herbal remedies; homeopathic medicines; traditional medicines; probiotics; and other products like amino acids and essential fatty acids).
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 licensing is not intended to restrict the quantity or value of imports; it is intended to ensure that imported health products meet Canadian standards of safety, quality, and efficacy. Licensing is the most cost-effective way to monitor importers.
Questions for products under restriction as to the quantity or value of imports
Import of health products by licence holders is not restricted as to the quantity or value of the imports.
The system applies to products originating from which country?
The above systems apply to the specified health products from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The following relates to import licensing and administrative procedures for health products under the Food and Drugs Act and its associated regulations. Different health products, covered under the Act, are subject to different regulations as listed below:
- Food and Drug Regulations;
- Blood Regulations;
- Medical Devices Regulations;
- Natural Health Products Regulations;
- Processing and Distribution of Semen for Assisted Conception Regulations;
- Safety of Cells, Tissues and Organs for Transplantation Regulations.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Product designation is not subject to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
Legislative approval would be required to abolish the licensing/registration systems described above.
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?
Any person, including a natural person or a legal entity meeting the legal definition of a person, is eligible to apply for a licence or registration.
Applicants that do not have a Canadian address must provide the address of a representative in Canada with the exception of medical devices where the applicant is not required to have a Canadian representative.
Is there a registration fee?
There are fees associated with drugs and medical devices for both product and establishment licences.
Is there a published list of authorized importers?
There is a published list of drug and medical device product licences and establishment licences. For CTO establishments, this information is made available upon request at the following address: roeb.cto-dgoral@hc-sc.gv.ca.
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?
Applications for product licences vary according to product but all the requirements are detailed in the applicable regulations and guidance. Applications for establishment and site licences and CTO registration must contain information on the applicant's name and address and contact information; the activities proposed; the product type; the address of each building where an activity will take place; and a statement that they meet the applicable requirement of the regulations. For blood establishment licences, as part of the application, the importer must submit evidence of compliance for every foreign establishment where the blood is processed.
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?
A licence or registration for the importer and/or product must have been obtained prior to importation.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No, licence applications and importation are not limited according to time of year.
Issuing the license
Can a licence be granted immediately on request?
No, a licence cannot be granted immediately on request. Establishment licences, site licences, and product licences are issued if a review of the application indicates that all requirements of the applicable regulations have been met. CTO registration is issued if a review of the application indicates that all the requirements of registration are met, including a statement that they are in compliance with the regulations.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
No, licences cannot be obtained in a shorter time frame for products arriving at the port where the importer has not already obtained one.
Time to obtain a licence depends on a variety of factors and will depend on the individual case.
Which administrative body is responsible for approving application of licences?
Health Canada is the only authority with respect to the above licences or registration.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
An establishment licence may be subject to terms and conditions as specified by the Minister on the licence when the licence is issued. These conditions vary according to the licence. For drug establishment licences, terms and conditions can be added or modified at any time.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There are no fees for semen, blood, CTO, or NHP, as these are not cost recovered. There are fees for drug and medical device product and establishment licences.
What is the amount of the fee or charge?
These fees are published in the Fees in Respect of Drugs and Medical Devices Regulations and depend on the type of licence involved.
Is there any deposit or advance payment required associated with the issue of licences?
Where fees apply a deposit or advance payment is required for the issuance of a licence.
Amount or rate?
Again this amount varies as per the licence and is published in the regulations.
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?
Failure to meet the criteria specified in the regulations will result in an application being refused.
Are the reasons for any refusal given to applicants?
Reasons for refusal are given to the applicant.
Have applicants a right of appeal in the event of refusal to issue a licence?
There are regulatory requirements for Health Canada to provide the applicant with an opportunity to be heard.
If so, to what bodies and under what procedures?
Review of the decision is internal to Health Canada. Applicants have a final right of appeal through the federal court system.
Importation
Are there any limitations as to the period of year during which importation may be made?
No, licence applications and importation are not limited according to time of year.
What documents are required upon actual importation?
No specific documents are required upon importation, just evidence that the applicable licences are in place. The Health Products and Food Branch of Health Canada and Regulatory Operations and Enforcement Branch can confirm that these have been issued.
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?
Drug Establishment licences and Medical Device Establishment Licences are subject to annual renewal prior to 1 April each year; Blood Establishment Licences have no expiry and no annual renewal; CTO registration is subject to renewal in the year following the year in which the registration is issued; and drug and medical device product licences require annual notification. NHP site licences must be renewed annually for the first three years, every other year for the next six years, and every third year after that; product licences are for an indefinite period.
The validity period cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No penalty is imposed for non-utilization of a licence or registration.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are issued to a specific person. To change the name of the licence holder a new license application is required.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.