Sperm and ova primary establishment registration application and ... · Ova Regulations as an establishment that conducts all processing activities in respect of sperm or ova, whether

Protected A

when completed

Important: Key or cautionary information for people to know.

Information: Supplementary information like quotes and legal references.

Tip: Things for people to do or understand.

Before completing this form, we recommend that you read the relevant

sections of the Safety of Sperm and Ova Regulations (https://laws-

lois.justice.gc.ca/eng/regulations/SOR-2019-192/index.html) and Health

Canada’s Guidance Document – Safety of Sperm and Ova Regulations

(https://www.canada.ca/en/health-canada/programs/consultation-safety-

sperm-ova-regulations/document.html).

Please also read Instructions on how to complete the sperm and ova

primary establishment registration application and establishment

notification form before completing this application form.

For any questions or clarifications, please email the Biological Products

Compliance Program at [email protected].

Sperm and ova primary establishment registration application

are intended to be used.

The following table shows the three types of icons used in this document, and the way they

and establishment notification form (FRM-0446)

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2019-192/index.html

https://www.canada.ca/en/health-canada/programs/consultation-safety-sperm-ova-regulations/document.html

mailto:[email protected]


Protected A when completed

Sperm and ova primary establishment registration application and establishment notification form (FRM-0446) v1 Page 2 of 20

This form must be completed by all primary establishments in order to obtain

a registration number.

A primary establishment is defined in Section 1 of the Safety of Sperm and

Ova Regulations as an establishment that conducts all processing activities in

respect of sperm or ova, whether it conducts them itself or another

establishment conducts any of the activities on its behalf.

Prior to importing or distributing sperm or ova, this form must be completed

by establishments that intend to import or distribute in Canada donor sperm

or ova for the purpose of Assisted Human Reproduction (AHR) to comply with

the notification requirements.





Ova Regulations under the Assisted Human Reproduction Act.

Privacy Act. We only collect the information we need to administer the Safety of Sperm and

The personal information you provide to Health Canada is governed in accordance with the

personal information has been handled improperly.

have the right to file a complaint with the Privacy Commissioner of Canada if you think your contact Health Canada’s Privacy Coordinator at [email protected]. You also information. For more information about these rights, or about our privacy practices, please Privacy Act gives you the right to request access to and correction of your personal Your rights under the Privacy Act: In addition to protecting your personal information, the

and will be included on Info Source.

government-employee-information.html. A Personal Information Bank is under development canada/activities-responsibilities/access-information-privacy/info-source-federal- available online at https://www.canada.ca/en/health-canada/corporate/about-health-

For more information: This personal information collection is described in Info Source,

delays in processing your request and may result in the refusal of your application.

Refusal to provide the information: Failure to provide the requested information will result in

disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.

Other uses or disclosures: In limited and specific situations, your personal information may be

Sperm and Ova Regulations under the Assisted Human Reproduction Act.

Purpose of collection: We require your personal information to administer the Safety of

Privacy notice

https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/info-source-federal-government-employee-information.html







Part 1: Type of application or notice Registration (complete parts 2 and 4)

Initial application for registration: Select this if your primary establishment is submitting a registration

application for the first time.

Change of information: Select this if you have an existing primary establishment registration number.

Reason for submission: Information update Amendment of Registration

Notice of cessation for registration (complete parts 2A and 5)

Cessation of activities: Select this if you have ceased all registered activities at your establishment.

Notification (complete parts 3 and 4)

Initial notification: Select this if you are submitting a notification to Health Canada that your

establishment intends to import or distribute donor sperm or ova for the purpose of AHR.

Change of information: Select this if you previously notified Health Canada and wish to modify the

information provided.

Reason for submission: Information update

Notice of cessation for notification (complete parts 3A and 5)

Cessation of activities: Select this if you have ceased all importation or distribution activities at your

establishment.



Part 2: Registration A) Primary establishment information Primary establishment registration number (if applicable):

Primary establishment name (name displayed on registration certificate):

Previous name of establishment (if applicable):

Civic address

Building name (if applicable):

Street number: Street name: Suite:

City: Province/State: Postal/Zip Code:

Country:

Mailing address (where correspondence and registration certificate are to be sent) same as above

Street number/P.O. box: Street name: Suite:

City: Province/State: Postal/Zip code:

Country:

Primary contact information

Contact’s first name, last name and title:

Language:

English French

Telephone: E-mail:

Secondary contact information (may be used in case of an emergency)

Contact’s first name, last name and title:

Language:

English French

Telephone: E-mail:



B) Activities and building information Select all activities that your establishment conducts. Repeat this part for all buildings where activities are conducted.

Address where activities are conducted

same as above




Country:

Activities

Gamete

Sperm Ova

1. Donor suitability assessment - donor screening

2. Donor suitability assessment - physical examination

3. Donor suitability assessment - donor testing

4. Obtaining

5. Preparing

6. Identifying

7. Testing

8. Preserving

9. Assessing quality

10. Labelling

11. Quarantining

12. Storing

C) Type of process (optional):

Regular process Directed donation process

Additional information (optional)



D) Establishments conducting activities on your behalf Repeat this part for each establishment conducting activities on your behalf.

Establishment name: Registration number (if applicable):


City: Province/State: Country: Postal/Zip Code:

Activities

Gamete

Sperm Ova

1. Donor suitability assessment - donor screening

2. Donor suitability assessment - physical examination

3. Donor suitability assessment - donor testing

4. Obtaining

5. Preparing

6. Identifying

7. Testing

8. Preserving

9. Assessing quality

10. Labelling

11. Quarantining

12. Storing

Additional information (optional)



Part 3: Notification of importation or distribution activities A) Establishment information

same as part 2A primary establishment information

Primary establishment registration number (if you are also a primary establishment):

Establishment name:

Previous name of establishment (if applicable):

Civic address




Country:

Mailing address (where correspondence is to be sent)

same as above Street number/P.O box: Street name: Suite:


Country:

Primary contact information

Contact’s first name, last name and title: Language:

English French

Telephone: E-mail:

Secondary contact information (may be used in case of an emergency)

Contact’s first name, last name and title: Language:

English French

Telephone: E-mail:



B) Activities and building information

Select all activities that your establishment conducts. Copy this part as many times as required.

Address where activities are conducted same as above




Country:

Activities Gamete

Sperm Ova

Distributing

Projected start date (yyyy-mm-dd)

Importing

Projected start date (yyyy-mm-dd)

C) Primary establishment that processes the sperm or ova that you are importing or distributing

Primary establishment name Registration

number Activities

Importation Distribution

Sperm

Ova

Sperm

Ova

Sperm

Ova

Sperm

Ova

Sperm

Ova

Sperm

Ova

Sperm

Ova

Sperm

Ova

If you are a primary establishment that imports from an establishment conducting activities on your behalf, list the establishment’s name below.



Part 4: Signature and Attestation This section must be completed by your establishment’s senior executive officer before submitting the form to Health Canada. Select all attestations that apply to your establishment

Registration: I, as the senior executive officer, hereby certify (i) that the primary establishment named in this application has evidence demonstrating that it is able to meet the requirements of the Safety of Sperm and Ova Regulations, (ii) that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of the Safety of Sperm and Ova Regulations, (iii) that all information submitted in support of the application is accurate and complete, and (iv) that I , the senior executive officer, have the authority to bind the establishment.

Notification: I, as the senior executive officer, hereby certify (i) that the establishment named in this application has evidence demonstrating that it is able to meet the requirements of the Safety of Sperm and Ova Regulations, (ii) that all information submitted in support of the notification is accurate and complete, and (iii) that I, the senior executive officer, have the authority to bind the establishment.

Name of senior executive officer: Title:

Telephone: E-mail:

Signature: Date (yyyy-mm-dd):



Registration

As per section 11 Notice to Minister of the Safety of Sperm and Ova Regulations, I, as the senior executive officer, hereby confirm that (i) if the primary establishment named in this application has not ceased all of its activities, it has evidence demonstrating that it meets the requirements of the Safety of Sperm and Ova Regulations, (ii) that if the primary establishment named in this application has not ceased all of its activities, any other establishment that processes sperm or ova or is proposed to process sperm or ova on its behalf meets the requirements of the Safety of Sperm and Ova Regulations, (iii) that all information submitted in support of the notice is accurate and complete, and (iv) that I, the senior executive officer, have the authority to bind the establishment.

Gamete

Sperm Ova

Details of the disposition of the sperm or ova in the primary establishment’s possession or control:


Signature: Effective date of cessation (yyyy-mm-dd):

Notification

As per section 19 Change or cessation of the Safety of Sperm and Ova Regulations, I, as the senior executive officer, hereby confirm that (i) the establishment has evidence, if it is still distributing or importing sperm or ova, demonstrating that it meets the requirements of the Safety of Sperm and Ova Regulations, (ii) that all information submitted in support of the notice is accurate and complete, and (iii) that I, the senior executive officer, have the authority to bind the establishment.

Activity Gamete

Importation Sperm Ova

Distribution Sperm Ova

Details of the disposition of the sperm or ova in the primary establishment’s possession or control:


Signature:

Effective date of cessation (yyyy-mm-dd):

Part 5: Notice of cessation

Sperm and ova primary establishment registration application and establishment notification form (FRM-0446) version 1 Page 12 of 20

Instructions on how to complete the sperm and ova primary establishment registration application and establishment notification form (FRM-0446)

A checklist is provided after part 5. It is not mandatory to complete the checklist,

however it is provided for your convenience and it is recommended that you

complete it to ensure that all fields have been filled out as required.

Part 1: Type of application or notice

Registration

As per section 4 of the Safety of Sperm and Ova Regulations, a primary

establishment that processes sperm or ova must be registered and may

process sperm or ova, subject to any change under paragraph 11(1)(a), only

in accordance with its registration.

Primary establishment means an establishment that conducts all processing

activities in respect of sperm or ova, whether it conducts them itself or

another establishment conducts any of the activities on its behalf.

Initial application for registration: Select this option if you are registering as a primary establishment for the first time. Complete parts 2 and 4.

Change of information: Select this option if you are changing the information already provided to Health Canada (you have an existing primary establishment registration number). Complete parts 2 and 4. Reason for submission:

(a) Information update: Select this option if there has been a change to your establishment

information. Submit this form with your updated information within 30 days after the

change.

(b) Amendment of registration: Select this option if your establishment processes only one

of sperm or ova and proposes to begin processing the other.

Notice of cessation for registration:

Cessation of activities: Select this option if your primary establishment has ceased its

activities that require a registration. This includes the cessation of activities with respect





to either sperm or ova if the registration is for both sperm and ova. Complete parts 2A

and 5.

Notification

As per section 18 of the Safety of Sperm and Ova Regulations, before

distributing or importing sperm or ova, an establishment must send to the

Minister a notice, in the form established by the Minister.

Initial notification: Select this option if you are submitting a notification to Health Canada for

the first time. Complete parts 3 and 4.

Change of information: Select this option if you previously submitted a notification to Health

Canada and wish to modify the information provided. Complete parts 3 and 4.

Reason for submission:

Information update: Select this option if there has been a change to your establishment

information. Submit this form with your updated information within 30 days after the

change.

You only need to notify Health Canada (initial notification) about your intent

to import or distribute once, however you must submit any change as per

sub-section 19(1) of the Safety of Sperm and Ova Regulations, within 30 days.

Notice of cessation for notification:

Cessation of activities: Select this option if your primary establishment has ceased its

importation and/or distribution activities. This includes the cessation of activities with

respect to either sperm or ova. Proceed to complete parts 3A and 5.

Part 2: Registration

Complete this section if you are a primary establishment that is responsible for all processing activities with respect to donor sperm or ova for purposes of AHR.

A) Primary establishment information:

- Primary establishment registration number (if applicable): Provide your primary

establishment’s registration number if applicable (you would have this number if you








are applying for “Change of information” but not if you are applying for “Initial

application for registration”).

- Primary establishment name: This is the legal name of your establishment and will be

displayed on your establishment registration certificate.

- Previous name of establishment (if applicable): In the case of an applicant that previously

conducted its activities under another name, either under the Safety of Sperm and Ova

Regulations or the Processing and Distribution of Semen for Assisted Conception

Regulations, provide this name.

Civic address:

- Provide the building name (if applicable) and civic address of your primary

establishment.

Mailing address:

- Provide the mailing address if different from your establishment civic address.

Primary contact information and secondary contact information:

- Provide your establishment primary and secondary contact information.

B) Activities and building information:

- Provide the building name (if applicable) and address of where activities are conducted.

- Select all activities that your establishment conducts. Any activities that are conducted

by another establishment on your behalf must be listed in part 2B.

- Repeat this table as many times as required for each building conducting activities.

Number the additional buildings in order of appearance by using “_____ of _____”. For

example, “2 of 5” would indicate that this building is the second of five additional

buildings submitted.

C) Type of process (optional):

- Select whether your establishment intends to process under the “Regular process” or

“Directed donation process” as per the Safety of Sperm and Ova Regulations.

- Provide any additional information (optional).


In the case where the donor and recipient know one another, the donor

sperm or ova may be processed in accordance with the Directed Donation

Process requirements as set out in sections 31 to 40 of the Safety of Sperm

and Ova Regulations provided the conditions under section 30 of the Safety

of Sperm and Ova Regulations are met.

D) Establishments conducting activities on your behalf:

- Fill out this section for each establishment conducting activities on your behalf. For

example, a laboratory conducting donor testing on your behalf or a clinic obtaining ova

on your behalf.

- Provide the name, registration number (if applicable) and address of any establishment

conducting activities on your behalf.

- Select all activities and gamete information that are conducted by another

establishment on your behalf.

- Copy this table as many times as required for each establishment conducting activities

on your behalf. Number the additional addresses in order of appearance by using

“_____ of _____”. For example, “2 of 5” would indicate that this address is the second

of five additional addresses submitted.


Part 3: Notification or importation of distribution activities

Complete this section if your establishment intends to import or distribute donor sperm or ova for purposes of AHR.

Select the box (same as part 2A primary establishment information) if your establishment is applying for a registration and submitting a notification.

A) Establishment information (if different from part 2):

- Primary establishment registration number (if applicable): provide your establishment

registration number if you are registered with Health Canada.

- Establishment name: provide the legal name of your establishment that intends to

import or distribute donor sperm or ova.

- Previous name of establishment (if applicable): provide the previous name of your

establishment in the case where regulated activities were previously conducted.

Civic address:




- Provide the building name (if applicable) and civic address of the establishment.

Mailing address:

- Provide the mailing address if different from your establishment civic address.

Primary contact information and secondary contact information:

- Provide your establishment primary and secondary contact information.

B) Activities and building information

- Provide the building name (if applicable) and address of where activities are conducted.

- Select all activities and gamete information that your establishment conducts.

- Repeat this table for each building where activities are conducted.

C) Primary establishment from whom you are importing or distributing:

- Provide the name and registration number of each primary establishment that

processes the sperm or ova imported or distributed by your establishment.

- Select whether you are importing or distributing sperm and/or ova from this

establishment.

If you are registered with Health Canada as a primary establishment and you

are importing from a foreign establishment conducting activities on your

behalf, include your primary establishment name and registration number in

this section.

Pursuant to sub-section 86(1) of the Safety of Sperm and Ova Regulations,

any primary establishment that processes sperm or ova before the Safety of

Sperm and Ova Regulations come into force may continue to do so without

having been registered provided it submits an application for registration to

Health Canada within 90 days after the day on which the Safety of Sperm and

Ova Regulations come into force. This applies until the registration number is

issued by Health Canada or the application for registration is refused.

- If this is your first time registering your primary establishment and also submitting a

notification at the same time, you will not have a registration number yet. In this case,

leave the registration number blank.



Foreign establishments that process sperm or ova may register with Health

Canada as a primary establishment to facilitate the distribution in Canada of

sperm or ova that they process, or be listed on the registration of a primary

establishment as an establishment that is conducting processing activities on

behalf of the primary establishment.

- This section must be completed by primary establishments importing from foreign

establishments that are listed on their registration and are conducting activities on their

behalf.

- If you are a primary establishment that imports from establishments conducting

activities on your behalf, list the foreign establishments’ names.


Part 4: Signature and Attestation

This section must be completed by a senior executive officer and submitted

by April 1st of each year.

Complete this section if you are a primary establishment submitting an application for a

registration or an establishment submitting a notification.

Select the box that applies to you. If you are applying for a registration and submitting a

notification, select both boxes.

Only signed (e-signature is accepted) and dated applications will be accepted.

Part 5: Notice of cessation

This section must be completed by a senior executive officer.

Complete this section if activities requiring a Health Canada sperm and ova registration

or notification have ceased at your establishment.

Select the box that applies to you. If activities requiring both a Health Canada sperm and

ova registration and notification have ceased at your establishment, select all relevant

boxes.


Provide details of the disposition of the sperm or ova that are in the possession or

control of the primary establishment. For example, sperm or ova that is under the

possession of your primary establishment or at an establishment conducting activities

on your behalf.

Only signed (e-signature is accepted) and dated applications will be accepted.


Application checklist (optional) – FRM-0446

Application Type of Application To Be Completed

Registration

Initial application for registration

Cover letter (recommended)

Application checklist (recommended)

Part 2

Part 4

Change of information

Information update



Part 2

Part 4

Amendment of registration



Part 2

Part 4

Notice of cessation for registration

Cessation of activities



Part 2A

Part 5

Notification

Initial notification:



Part 3

Part 4

Change of information

Information update



Part 3

Part 4

Notice of cessation for notification

Cessation of activities



Part 3A

Part 5

If you are applying for a registration and submitting a notification, please

ensure all appropriate sections of the form are completed.


How to submit your form

Before submitting this form, please ensure that the senior executive officer has signed part 4

Signature and Attestation. In the case of notice of cessation, the senior executive officer must

sign part 5.

When ready to submit your form, send an email with your completed application form attached

to the Biological Products Compliance Program at hc.ahrregistration-

[email protected]. In order to facilitate processing, we recommend including your

establishment name in the subject line of the email.

For any questions, please send your inquiries by email to the Biological Products Compliance

Program at [email protected].

As per section 20 of the Safety of Sperm and Ova Regulations, a primary

establishment and any other establishment that distributes or imports sperm

or ova must send to the Minister, in the form established by the Minister, an

annual attestation (a) on or before April 1 of the calendar year following the

year of registration or the year in which the notice of distribution or

importation is sent; and (b) on or before April 1 of each subsequent calendar

year.

If unable to submit by email:

Fax: (613)-960-2156

Mail: Biological Products Compliance Program

Regulatory Operations and Enforcement Branch

3rd floor Jeanne Mance Building

200 Eglantine Driveway, Tunney’s Pasture

Address Locator 1903D

Ottawa, Ontario

K1A 0K9










Documents

Sperm and ova primary establishment registration application and ... · Ova Regulations as an establishment that conducts all processing activities in respect of sperm or ova, whether