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Reporting of Adverse Event for Assisted Reproductive Technology

Application under Direction 6.3 and /or Direction 8.2 prior to importing donor gametes or embryos into Western Australia
Application under Direction 6.3 and /or Direction 8.2 prior to the import donor gametes or embryos into Western Australia
Application Date:*
DD slash MM slash YYYY

Clinic Name:*

Patient ID Code:*

Partner ID Code (if applicable)

Name of Current Storage Clinic:*

Address of Current Storage Clinic*
Street Address City State / Province / Region ZIP / Postal Code Country

The Number of Each Item to be Imported:
Embryos
Oocytes
Sperm Straws/Vials
Evidence of compliance with the requirements outlined in the Guidelines must be provided.
Please attach supporting documents to accompany the application.The required documents are listed below:
Section 53Q HRT Act Compliance
1. A copy of all fees incurred by the applicant in relation to obtaining the donated gametes or embryos, verified by receipts or other documentation (53Q HRT Act).
2. Evidence of all payments made to the donor, verified by receipts or other documentation (53Q HRT Act).

Drop files here or

Max. file size: 64 MB.

Information and Counselling*
3. A copy of the written information provided to the donor.
4. A letter from the counsellor to confirm counselling has been provided.
5. Evidence that counselling to the donor was provided by a health professional with equivalent qualifications of a "counsellor". "Counsellor” means a person who is eligible for full membership of the Australian and New Zealand Infertility Counsellors Association (HRT Directions 2021).
(upload files to support points 3, 4 & 5 here)

Drop files here or

Max. file size: 64 MB.

Consent*
6. A copy of the consent to donate form signed by the donor/s and the donor’s partner (if applicable).
7. A copy of the consent to import gametes into WA signed by the donor/s and partner (if applicable).
(upload files to support points 6 & 7 here)

Drop files here or

Max. file size: 64 MB.

Number of Recipient Families*
8. Evidence regarding the current number of recipient families and the potential maximum number of recipient families for the donor (including families outside WA).
(upload files to support point 8 here)

Drop files here or

Max. file size: 64 MB.

Legal Advice*
9. A copy of independent legal advice as per RTAC 2011 Technical Bulletin 3.
(upload files to support point 9 here)

Drop files here or

Max. file size: 64 MB.

The application cannot be processed if any one of the above requirements can not be met.

Application under Direction 6.3 to import without information for the registers - please provide:
10. The Information required under schedule 2 of the Directions that will not be available.
11. The details of any compassionate grounds to support this application.
(upload files to support points 10 & 11 here)

Drop files here or

Max. file size: 64 MB.

Application under Direction 8.2 to approve a use that may result in more than five families provide:
12. A detailed explanation of the exceptional circumstances for this particular case to warrant exceeding the five family limit.
(upload files to support point 12 here)

Drop files here or

Max. file size: 64 MB.

Name of Person Submitting Application:*

Designation of Person Submitting Application:*

Email Address of Person Submitting Application*

Name
This field is for validation purposes and should be left unchanged.

Serious Adverse Event Notification

ART Serious Adverse Event Notification Guidelines (PDF 18.69 KB)

Serious adverse events REDCap notification link

Information for Clinics

Policies, Notices and Guidelines

Application Forms

Application under Direction 6.3 and /or Direction 8.2 prior to the import donor gametes or embryos into Western Australia

Serious Adverse Event Notification

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Reproductive Technology Unit

For licensing and general matters email RTU, Department of Health

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