Donor sperm and ova

Member: 

Basic information

1

Outline of the 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.

2

Product coverage

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.

Nature of licensing

Automatic

3

If Automatic, administrative purpose

Non-Automatic

4

If Non-Automatic, description of the notified Non-Automatic Licensing regime

5

Products under restriction as to the quantity or value of imports

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.

6

Questions for products under restriction as to the quantity or value of imports

Not applicable.

7

The system applies to products originating from which country?

The system applies to all countries.

8

Expected duration of licensing procedure

Eligibility of applicants

12

Is there a system of registration of persons or firms permitted to engage in importation?

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.

13

What persons or firms are eligible to apply for a licence?

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.

14

Is there a registration fee?

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.

15

Is there a published list of authorized importers?

Contact point for information on eligibility

16

Ministry/Authority

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Address

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Telephone

19

Fax

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E-mail address

21

Website

22

Contact officer

Submission of an application

23

Administrative body(ies) for submission of an application

Documentation requirements

24

What information is required in applications?

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.

25

What documents is the importer required to supply with the application?

Establishments must submit the Sperm and Ova notification form prior to importing and/or distributing sperm and ova in Canada.
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-...

Window of submission of an application

26

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.

27

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

28

Can a licence be granted immediately on request?

No, a licence cannot be granted immediately on request.

29

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.

30

Which administrative body is responsible for approving application of licences?

Establishments that import and/or distribute sperm and ova in Canada must submit a notification to Health Canada prior to importation.

31

Must the applications be passed on to other organs for visa, note or approval?

Sperm and ova imported under the Safety Regulations must also have been processed by a primary establishment registered with Health Canada.

32

Are there any other conditions attached to the issue of a licence?

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.

Fees and other administrative charges

33

Is there any licensing fee or administrative 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.

34

What is the amount of the fee or charge?

35

Is there any deposit or advance payment required associated with the issue of licences?

Not applicable.

36

Amount or rate?

37

Is it refundable?

38

What is the period of retention?

39

What is the purpose of this requirement?

Refusal of an application

40

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 Health Canada taking compliance and enforcement measures.

41

Are the reasons for any refusal given to applicants?

42

Have applicants a right of appeal in the event of refusal to issue a licence?

43

If so, to what bodies and under what procedures?

Importation

44

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.

45

What documents are required upon actual importation?

No specific documents are required upon importation, just evidence that the applicable licences are in place.

46

Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

No.

Conditions of licensing

47

What is the period of validity of a licence? Can the validity 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.

48

Is there any penalty for the non-utilization of a licence or a portion of a licence?

No.

49

Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Licences are not transferable.

Foreign Exchange

50

Is foreign exchange automatically provided by the banking authorities for goods to be imported?

Not applicable.

51

Is a licence required as a condition to obtaining foreign exchange?

Not applicable.

52

Is foreign exchange always available to cover licences issued?

Not applicable.

53

What formalities must be fulfilled for obtaining the foreign exchange?

Not applicable.