Donor sperm and ova
- 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 AHR Act prohibits the importation and/or the distribution in Canada of donor sperm and ova for the purpose of AHR, unless the sperm and ova are processed by a primary establishment that is registered with Health Canada.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The Safety Regulations require that primary establishments that are responsible for all of the processing activities with respect to donor sperm and ova be registered with Health Canada.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to 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 importation into Canada of sperm and ova for assisted human reproduction are not subject to licensing, but imported gametes must meet Canadian standards for safety, as expressed in the Safety Regulations.
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 donor sperm and ova under the Assisted Human Reproduction Act and the Safety of Sperm and Ova Regulations (Safety Regulations).
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.
Time to obtain a licence depends on a variety of factors and will depend on the individual case.
Q7.b. Can a licence be granted immediately on request?
No, a licence cannot be granted immediately on request.
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?
Establishments that import and/or distribute sperm and ova in Canada must submit a notification to Health Canada prior to importation. Sperm and ova imported under the Safety Regulations must also have been processed by a primary establishment registered with Health Canada.
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 Health Canada taking compliance and enforcement measures.
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?
Establishments, as defined in the Safety Regulations, are eligible to import sperm and ova in Canada. Any person can import sperm or ova and therefore be considered an establishment.
The Safety Regulations do not require establishments who import and/or distribute sperm and ova to register, but they must notify Health Canada using a notification form.
An establishment must keep records for importation and/or distribution that contain all the documents and information required under the Safety Regulations and all other records that demonstrate that they meet the requirements of the Safety Regulations.
There are no fees associated with sperm and ova registrations, notifications or annual attestations as they are not cost recovered. Information on notifications is available upon request at the following address: ahrregistration-enregistrementpa@hc-sc.gc.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?
All records relating to the importation and distribution of donor sperm and ova must include the donor identification code and the donation code for each unit of sperm or ova.
Applications for notifications must contain information on the establishment's name, telephone number, email address, postal address and, if different from the postal address, civic address; a statement indicating whether the establishment proposes to distribute or import sperm or ova and the projected start date; the civic address of the buildings in which the establishment proposes to conduct the activities; the first name, last name, telephone number and email address of a person to contact for further information concerning the notice and, if different, a person to contact in case of emergency; in the case of an establishment that previously conducted its activities under another name, that other name; and the name and registration number of each primary establishment that processes that sperm or those ova.
Establishments must submit the Sperm and Ova notification form prior to importing and/or distributing sperm and ova in Canada.
Q11. What documents are required upon actual importation?
No specific documents are required upon importation, just evidence that the applicable licences are in place.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There are no fees associated with semen and ova registrations, applications, notifications or annual attestations as they are not cost recovered. Information on notifications is available upon request at the following address: ahrregistration-enregistrementpa@hc-sc.gc.ca.
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.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Although a notification does not have an expiry date, establishments must send Health Canada an annual attestation of compliance by 1 April of each year by submitting the Sperm and ova establishment annual attestation form.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable.
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?
If there are any changes to the information provided on the notification form or if importation stops, these changes must be filed with Health Canada using the notification form and include an accompanying cover letter summarizing the changes.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.