Regulations for Assisted Reproduction Information Notification and Administration
2015-04-20
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Article 1
These Regulations are prescribed pursuant to Article 27, Paragraph 2 of the Assisted Reproduction Act (hereinafter referred to as "this Act").
Article 2
An assisted reproduction institution (hereinafter referred to as "Institution") shall notifythe following assisted reproduction information to the competent authority:
1. Health examination and assessment of reproductive cell donor;
2. Results of operations involving donated reproductive cells;
3. Information concerning the incomplete donation, return, destruction, or transfer of reproductive cells or embryos created from donated reproductive cells;
4. Information concerning all the initiated cycles with or without the use of ovulation induction drugs in assisted reproduction cases;
5. Assisted reproduction cases data;
6. Information concerning destruction of recipient couples' reproductive cells or embryo.
1. Health examination and assessment of reproductive cell donor;
2. Results of operations involving donated reproductive cells;
3. Information concerning the incomplete donation, return, destruction, or transfer of reproductive cells or embryos created from donated reproductive cells;
4. Information concerning all the initiated cycles with or without the use of ovulation induction drugs in assisted reproduction cases;
5. Assisted reproduction cases data;
6. Information concerning destruction of recipient couples' reproductive cells or embryo.
Article 3
An Institution shall fill out and submit a Reproductive Cell Donation Checking Application Form (Attached Form 1) and apply to the competent authority for checking prior to receiving reproductive cells donation.
- Attached Form 1 Reproductive Cell Donation Checking Application Form.PDF
Article 4
The competent authority shall record the donor data to an assisted reproduction database after it receives a checking application as described in the proceeding article. Where the donor data complies with the regulations of Article 8, Paragraph 1,Subparagraph 4 of this Act, it shall be classified as control data for subsequent management。
Where the competent authority discovers that the donor in question is already listed by another Institution when processing a checking application, it shall notify the applicant Institution in writing that it shall not accept a donation from that donor, and that any reproductive cells already obtained from that donor must be destroyed.
Where the competent authority discovers that the donor in question is already listed by another Institution when processing a checking application, it shall notify the applicant Institution in writing that it shall not accept a donation from that donor, and that any reproductive cells already obtained from that donor must be destroyed.
Article 5
After the donor’s qualification to donate sperm is confirmed by the checking process, the Institution may obtain the donor's sperm on separate occasions within six months upon the first obtainment of the donor’s sperm. The Institution must confirm that the donor's health status is suitable for donation, and shall not simultaneously provide sperm from a single donor to two or more recipient couples.
Article 6
The donor’s information classified as control data under Article 4 shall not be removed from control unless one of the following conditions is satisfied:
1. The donor has not actually completed donation procedures, and the competent authority has been notified.
2. The donor's reproductive cells or embryos created from donated reproductive cells have been completely destroyed, and the competent authority has been notified.
3. The donor's reproductive cells or embryos created from donated reproductive cells have been used but did not result in a live birth and were not stored after the operation, and the competent authority has been notified.
1. The donor has not actually completed donation procedures, and the competent authority has been notified.
2. The donor's reproductive cells or embryos created from donated reproductive cells have been completely destroyed, and the competent authority has been notified.
3. The donor's reproductive cells or embryos created from donated reproductive cells have been used but did not result in a live birth and were not stored after the operation, and the competent authority has been notified.
Article 7
An Institution shall fill out and submit a Reproductive Cell Donor Health Examination and Assessment Notification Form (Attached Form 2) within 14 days after the date of completion of health examination and assessment as provided in Article 7, Paragraph 1 of this Act.
- Attached Form 2 Reproductive Cell Donor Health Examination and Assessment Notification Form.PDF
Article 8
Where the performance of assisted reproduction for a recipient couple uses donated reproductive cells or embryos created from donated reproductive cells, the Institution shall fill out and submit the first leaf of a Donated Reproductive Cell Operation Results Notification Form (Attached Form 3) within 12 weeks after the date of the operation, and shall fill out and submit the second leaf of the same form within two months after the estimated date of childbirth.
- Attached Form 3 Donated Reproductive Cell Operation Results Notification Form.PDF
Article 9
Where one of the following conditions is satisfied, the Institution shall fill out and submit a Notification Form for Failure to Complete Donation, Return, Destruction, or Transfer of Reproductive Cells or Embryos Created from Donated Reproductive Cells (Attached Form 4) within two months after the date of its satisfaction:
1. A donor whose data is classified as control data under Paragraph 1 of Article 4 fails to complete donation.
2. The Institution returns undestroyed donated reproductive cells to a donor as provided in the proviso to Article 19 of this Act.
3. The Institution destroys donated reproductive cells or embryos created from donated reproductive cells as provided in Article 21, Paragraphs 1 through 4 of this Act.
When donated reproductive cells or embryos created from donated reproductive cells are transferred as provided in Article 20 and Article 21, Paragraph 4 of this Act, the transferring Institution shall provide photocopies of attached forms 1 through 3 for the case, the written consent forms of the donor or recipient couple, and the competent authority’s response to the transferee Institution for preservation, and the transferee Institution shall sign Attached Form 4 as confirmation.
The transferring Institution as described in the proceeding paragraph shall notify the competent authority by submitting Attached Form 4 within two months after the date of completion of transfer.
1. A donor whose data is classified as control data under Paragraph 1 of Article 4 fails to complete donation.
2. The Institution returns undestroyed donated reproductive cells to a donor as provided in the proviso to Article 19 of this Act.
3. The Institution destroys donated reproductive cells or embryos created from donated reproductive cells as provided in Article 21, Paragraphs 1 through 4 of this Act.
When donated reproductive cells or embryos created from donated reproductive cells are transferred as provided in Article 20 and Article 21, Paragraph 4 of this Act, the transferring Institution shall provide photocopies of attached forms 1 through 3 for the case, the written consent forms of the donor or recipient couple, and the competent authority’s response to the transferee Institution for preservation, and the transferee Institution shall sign Attached Form 4 as confirmation.
The transferring Institution as described in the proceeding paragraph shall notify the competent authority by submitting Attached Form 4 within two months after the date of completion of transfer.
- Attached Form 1 Reproductive Cell Donation Checking Application Form.PDF
- Attached Form 2 Reproductive Cell Donor Health Examination and Assessment Notification Form.PDF
- Attached Form 3 Donated Reproductive Cell Operation Results Notification Form.PDF
- Attached Form 4 Notification Form for Failure to Complete Donation, Return, Destruction, or Transfer of Reproductive Cells or Embryos Created from Donated Reproductive Cells.PDF
Article 10
An Institution shall fill out and submit a weekly Case Report Form for All the Initiated Cycles with the Used of Ovulation Induction Drugs in Assisted Reproduction (Attached Form 5) for the cases receiving treatment during the previous week.
The Institution shall conduct a health examination and assessment of recipient couples in accordance with the items listed in Attached Form 6, and shall record the results in Attached Form 5.
The Institution shall conduct a health examination and assessment of recipient couples in accordance with the items listed in Attached Form 6, and shall record the results in Attached Form 5.
- Attached Form 5 Case Report Form for All the Initiated Cycles with or without the Use of Ovulation Induction Drugs in Assisted Reproduction.PDF
- Attached Form 6 Recipient Couple Health Examinationand Assessment Form.PDF
Article 11
An Institution shall file an Assisted Reproduction Case Data Form (Attached Form 7) quarterly for the previous quarter via a reporting system designated by the competent authority.
- Attached Form 2 Reproductive Cell Donor Health Examination and Assessment Notification Form.PDF
- Attached Form 7 Assisted Reproduction Case Data Form.PDF
Article 12
An Institution shall file a Notification Form for Destruction of Reproductive Cells or Embryos from Recipient Couples (Attached Form 8) annually for the previous year via a reporting system designated by the competent authority.
- Attached Form 8 Notification Form for Destruction of Reproductive Cells or Embryos from Recipient Couples（excluding destruction of reproductive cells obtained from donation）.PDF
Article 13
The competent authority may inspect an Institution's assisted reproduction data whenever necessary.
Article 14
The competent authority shall assign its subordinate Health Promotion Administration or commission a relevant group to perform any of the matters prescribed in these Regulations and in Article 27, Paragraph 1 of this Act.
Article 15
These Regulations shall take effect on the date of promulgation.