Drugs, blood, natural health products and medical devices
- Document symbol
- G/LIC/N/3/CAN/22
- Original language
- English
- Published on
- 01/11/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another 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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
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).
Q3. The system applies to goods originating in and coming from which countries?
The above systems apply to the specified health products from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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;
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations.
Product designation is not subject to administrative discretion.
Legislative approval would be required to abolish the licensing/registration systems described above.
Procedures
Q6. 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):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? 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?
Q6.II. How is the size of the quotas determined: on a 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 fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted 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 the 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.)
Q6.IV. 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?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. 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?
Q6.VIII. 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?
Q6.IX. 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?
Q6.X. In cases where imports are allowed 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?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
A licence or registration for the importer and/or product must have been obtained prior to importation. No, licences cannot be obtained in a shorter time frame for products arriving at the port where the importer has not already obtained one.
Q7.b. 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.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No, licence applications and importation are not limited according to time of year.
Q7.d. 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?
Health Canada is the only authority with respect to the above licences or registration.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Failure to meet the criteria specified in the regulations will result in an application being refused. Reasons for refusal are given to the applicant. There are regulatory requirements for Health Canada to provide the applicant with an opportunity to be heard. Review of the decision is internal to Health Canada. Applicants have a final right of appeal through the federal court system.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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. There are fees associated with drugs and medical devices for both product and establishment licences. 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 follow address: roeb.cto-dgoral@hc-sc.gv.ca.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
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.
Q11. 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.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There are no fees for blood, CTO, or NHP, as these are not cost recovered. There are fees for drug and medical device product and establishment licences; these fees are published in the Fees in Respect of Drugs and Medical Devices Regulations and depend on the type of licence involved.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
Where fees apply, a deposit or advance payment is required for the issuance of a licence. Again, this amount varies as per the licence and is published in the regulations.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence 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.
Q15. 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.
Q16. 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.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.