Import Requirements Related to the Safety of Sperm and Ova Regulations

Health Canada’s guidance document on the Safety of Sperm and Ova regulations provides information on the safety inspection and import requirements under Health Canada.

The Safety of Sperm and Ova Regulations (Safety Regulations) came into force on February 4, 2020.? The Safety Regulations apply to donor sperm that is distributed by an establishment or health professional to a recipient for their personal use; however, they do not apply to that person’s own use of donor sperm to self-inseminate.

The Safety of Sperm and Ova Regulations apply to establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of assisted human reproduction (AHR).?

All establishments and health professionals that process, import, distribute or make use of donor sperm and ova (eggs) must:

Primary establishments:

  • must register with Health Canada
  • are responsible for all processing activities
    • whether they conduct the activity themselves or
    • another establishment conducts the activity on their behalf

Establishments that import or distribute must notify Health Canada.?

Both primary establishments and establishments that only import or distribute must submit an attestation of compliance every year.

Compliance monitoring activities in Canada

Health Canada carries out compliance monitoring activities, including inspections of regulated parties to:

  • verify compliance with the AHR Act and its Regulations
  • respond to issues of non-compliance
  • minimize the risk posed to the health of Canadians

For importation into Canada one or more of the following documents/information may be required under the CBSA Single Window Initiative(SWI),

  1. Semen or Ova Establishment Attestation (formerly Semen Processor Declaration)
  2. Establishment Notification Form (FRM-0446)
  3. Establishment Registration Number
  4. Donor Semen or Ova Letter of Authorization (LOA) (formerly  Donor Semen Letter of Authorization (LOA))

Further information on compliance and guidelines are available here.
Safety of Sperm and Ova Regulations.?
Inspection approach- Safety of Sperm and Ova Regulations
Compliance and Enforcement: Assisted Human Reproduction
Donating and using third-party sperm or ova (eggs) for assisted human reproduction

Sperm and ova primary establishment registration application and establishment notification form(FRM-0446)

Contact Us

If you have a question about Health Canada’s compliance and enforcement approach, contact the Biological Product Compliance Program:

Biological Product Compliance Program
Regulatory Operations and Enforcement Branch
200 Eglantine Driveway
Ottawa, Ontario
K1A 0K9