Assisted Reproductive Treatment Amendment Regulations 2025 (Vic)
Assisted Reproductive Treatment Amendment Regulations 2025
S.R. No. 69/2025
TABLE OF PROVISIONS
Regulation Page
1Objective
2Authorising provisions
3Commencement
4Principal Regulations
5Additional matters to be certified before bringing donated gametes or embryo produced from donor gametes into Victoria
6Additional matters to be certified before taking donated gametes or embryo produced from donor gametes from Victoria
7Record keeping for certification
8New regulation 25 inserted
9Schedule 3 amended
10Schedule 7 substituted
11Schedule 8 substituted
12New Schedule 11 inserted
═════════════
Endnotes
STATUTORY RULES 2025
S.R. No. 69/2025
Assisted Reproductive Treatment Act 2008
Assisted Reproductive Treatment Amendment Regulations 2025
The Governor in Council makes the following Regulations:
Dated: 15 July 2025
Responsible Minister:
MARY-ANNE THOMAS
Minister for HealthANGELA SMITH
Clerk of the Executive Council
1Objective
The objective of these Regulations is to amend the Assisted Reproductive Treatment Regulations 2019—
(a)to prescribe matters relating to certifications under section 36(3) or (4) of the Assisted Reproductive Treatment Act 2008; and
(b)to prescribe offences under the Assisted Reproductive Treatment Act 2008 as infringement offences and infringement penalties in respect of those infringement offences.
2Authorising provisions
These Regulations are made under sections 37D, 124 and 125 of the Assisted Reproductive Treatment Act 2008.
3Commencement
These Regulations come into operation on 1 August 2025.
4Principal Regulations
In these Regulations, the Assisted Reproductive Treatment Regulations 2019[1] are called the Principal Regulations.
5 Additional matters to be certified before bringing donated gametes or embryo produced from donor gametes into Victoria
(1)For regulation 9C(b) of the Principal Regulations substitute—
"(b)if the person is a registered ART provider, the person has—
(i)obtained a written undertaking from the transferring party that the transferring party will take all reasonable steps to give the donor written notice as soon as practicable of the person's name and contact details as a registered ART provider; or
(ii)given written notice to the donor of the person's name and contact details as a registered ART provider;
(ba)if the person is a doctor carrying out artificial insemination other than on behalf of a registered ART provider using the donor gametes, the person has—
(i)obtained a written undertaking from the transferring party that the transferring party will take all reasonable steps to give the donor written notice as soon as practicable of the person's name and contact details as a doctor carrying out artificial insemination; or
(ii)given written notice to the donor of the person's name and contact details as a doctor carrying out artificial insemination;".
(2)In regulation 9C(c) of the Principal Regulations, after "insemination" insert "other than on behalf of a registered ART provider".
6Additional matters to be certified before taking donated gametes or embryo produced from donor gametes from Victoria
(1)After regulation 9D(a) of the Principal Regulations insert—
"(ab)the donor of the gametes, or each person who donated the gametes used to produce the embryo, has consented in writing to the donor's gametes or embryo produced from the donor's gametes being taken from Victoria;
(ac)the person has been given a copy of—
(i)the donor's consent to the donor's gametes being taken from Victoria; or
(ii)the consent of each person who donated the gametes used to produce the embryo to the embryo being taken from Victoria;".
(2)In regulation 9D(f) of the Principal Regulations, after "insemination" (where first occurring) insert "other than on behalf of a registered ART provider".
7Record keeping for certification
After regulation 9G(2)(b) of the Principal Regulations insert—
"(ba)a copy of the donor's consent or the consent of each person who donated the gametes used to produce the embryo, provided in accordance with regulation 9D(ab);".
8New regulation 25 inserted
After regulation 24 of the Principal Regulations insert—
25Infringement offences and infringement penalties"
(1)For the purposes of section 116P(1) of the Act, an offence specified in Column 1 of the Table in Schedule 11 is a prescribed offence.
(2)For the purposes of section 116P(3) of the Act, the prescribed infringement penalty for a prescribed offence is the penalty set out in Column 2 of the Table in Schedule 11 in respect of the corresponding prescribed offence set out in Column 1 of that Table.".
9Schedule 3 amended
(1)After clause 10(1)(c) of Schedule 3 to the Principal Regulations insert—
"(ca)if the gametes were, or the embryo was, taken out of Victoria before 1 January 2025, the date on which the Victorian Assisted Reproductive Treatment Authority granted approval of the taking of the gametes or the embryo from Victoria under section 36(2) of the Act as in force immediately before the commencement of Part 2 of the Health Legislation Amendment (Regulatory Reform) Act 2024;".
(2)In clause 10(1)(d) of Schedule 3 to the Principal Regulations, for "the date" substitute "if the gametes were, or the embryo was, taken out of Victoria on or after 1 January 2025, the date".
10Schedule 7 substituted
For Schedule 7 to the Principal Regulations substitute—
"Schedule 7—Certification to bring donor gametes or embryos produced from donor gametes into Victoria
Regulation 9E(a)
Name of person making the certification:
Certification
For the purposes of section 36(3) of the Assisted Reproductive Treatment Act 2008 (the Act), I [name of person making the certification] of [address of person making the certification] propose to bring *donor gametes/*an embryo produced from donor gametes into Victoria and certify that—
o any payment made, any valuable consideration that is given or agreed to be given in connection with the donation or any agreement entered into for payment to be made or valuable consideration to be given in connection with the donation does not contravene the Human Tissue Act 1982, the Prohibition of Human Cloning for Reproduction Act 2008 or the Prohibition of Human Cloning for Reproduction Act 2002 of the Commonwealth; and
o the donor of the gametes, or each person who donated the gametes used to produce the embryo, has consented in writing to—
·the donor's gametes being brought into Victoria; and
· the use of the donor's gametes or the embryo produced from the donor's gametes in accordance with section 36(5) of the Act; and
· the storage of the embryo produced from the donor's gametes for the purpose of later transfer, or if an exemption has been granted in relation to section 32(2)(c) or (3) of the Act, any conditions to which the exemption is subject have been complied with; and
[if relevant, specify any conditions imposed by the Secretary on which the exemption is subject]
o I have been given a copy of—
·the donor's consent; or
·the consent of each person who donated the gametes used to produce the embryo; and
o the donor or each person who donated the gametes used to produce the embryo has received counselling in relation to prescribed matters from a counsellor who meets the prescribed requirements for counselling or, if an exemption has been granted in relation to section 18 of the Act, any conditions to which the exemption is subject have been complied with; and
[if relevant, specify any conditions imposed by the Secretary on which the exemption is subject]
o the donor or each person who donated the gametes used to produce the embryo has given information about the matters prescribed for the purposes of section 36(3)(e) of the Act or, if an exemption has been granted in relation to section 19(a) of the Act, any conditions to which the exemption is subject have been complied with; and
[if relevant, specify any conditions imposed by the Secretary on which the exemption is subject]
o the donor or each person who donated the gametes used to produce the embryo has been given written advice on the matters set out in section 19(b)(i) to (iv) of the Act or, if an exemption has been granted in relation to section 19(b) of the Act, any conditions to which the exemption is subject have been complied with; and
[if relevant, specify any conditions imposed by the Secretary on which the exemption is subject]
o I have taken all reasonable steps to ensure that any future use of the donor gametes or embryo produced from donor gametes in Victoria will comply with section 29 of the Act; and
o I have satisfied the following matters—
oI have obtained a written undertaking from the person transferring *the donor gametes/*embryo produced from the donor gametes (the transferring party) or the donor that the transferring party or the donor will notify me as soon as practicable of—
·any change to or withdrawal of the donor's consent; and
·any change to the donor's information provided under section 36(3)(e) of the Act;
o [if the person making the certification is a registered ART provider] I have—
oobtained a written undertaking from the transferring party that the transferring party will take all reasonable steps to give the donor written notice as soon as practicable of my name and contact details as a registered ART provider; or
oprovided written notice to the donor of my name and contact details as a registered ART provider;
o [if the person making the certification is a doctor carrying out artificial insemination other than on behalf of a registered ART provider using the donor gametes] I have—
oobtained a written undertaking from the transferring party that the transferring party will take all reasonable steps to give the donor written notice as soon as practicable of my name and contact details as a doctor carrying out artificial insemination; or
ogiven written notice to the donor of my name and contact details as a doctor carrying out artificial insemination;
o [if the person making the certification is a registered ART provider or a doctor carrying out artificial insemination other than on behalf of a registered ART provider using the donor gametes] I will use the unique donor identifier from the transferring party so far as is reasonably practicable;
o I have sighted the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature or a certified copy of the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature;
o I have received—
·the donor's email address (if any); and
·the donor's postal address;
o I have received information from the donor about whether the donor has donated or intends to donate gametes or an embryo to a person (other than a registered ART provider or a doctor) or an individual for the purposes of self-insemination.
Details
At the time of making this certification, the following details about the *donor gametes/*embryo produced from donor gametes to be brought into Victoria are accurate—
[specify the following details]
(a)contact details of person making the certification, including telephone number and address;
(b)the unique donor identifier(s);
(c)details about the *donor gametes/*embryo produced from donor gametes, including—
(i)number of vials, straws or containers of donor sperm; and
(ii)number of donor oocytes; and
(iii)number of embryos produced from donor gametes;
(d)details of the proposed transport or movement of the *donor gametes/*embryo produced from donor gametes, including—
(i)the name and contact details of the transferring party including the country in which the transferring party is located; and
(ii)the name and contact details of the person receiving the *donor gametes/*embryo produced from donor gametes; and
(iii)the date or proposed date of movement of the *donor gametes/*embryo produced from donor gametes into Victoria; and
(iv)the method of transportation.
Declaration
I acknowledge that providing information that I know or believe to be false or misleading is an offence.
Signed: [signature of person making certification]
Name: [print name]
Date:
Witness signed: [signature of witness]
Witness name: [print name]
Date:
*Delete if inapplicable.
Notes
1.Section 36(3) of the Act provides the matters that a person must certify before a person brings donor gametes or an embryo produced from donor gametes into Victoria.
2.Regulation 7A of the Assisted Reproductive Treatment Regulations 2019 prescribes the requirement for a counsellor for the purposes of section 36(3)(d) of the Act.
3.Regulation 9A of the Assisted Reproductive Treatment Regulations 2019 prescribes the matters about which a donor or each person who donated the gametes used to produce the embryo has received counselling for the purposes of section 36(3)(d) of the Act.
4.Regulation 9B of the Assisted Reproductive Treatment Regulations 2019 prescribes the matters about which a donor or each person who donated the gametes used to produce the embryo has given information for the purposes of section 36(3)(e) of the Act.
5.Regulation 9C of the Assisted Reproductive Treatment Regulations 2019 prescribes the additional matters that a person making a certification must satisfy for the purposes of section 36(3)(h) of the Act.".
11Schedule 8 substituted
For Schedule 8 to the Principal Regulations substitute—
"Schedule 8—Certification to take donor gametes or embryos produced from donor gametes from Victoria
Regulation 9E(b)
Name of person making the certification:
Certification
For the purposes of section 36(4) of the Assisted Reproductive Treatment Act 2008 (the Act), I [name of person making the certification] of [address of person making the certification] propose to take *donor gametes/*an embryo produced from donor gametes from Victoria and certify that—
o the purpose for which the *donor gametes/*embryo produced from donor gametes will be used outside Victoria is consistent with a purpose for which it could be used in Victoria; and
o the way in which the *donor gametes/*embryo produced from donor gametes will be used outside Victoria is consistent with the way in which it could be used in Victoria; and
o I have satisfied the following matters—
o I have provided the person receiving the donor gametes or embryo produced from donor gametes (the receiving party) with a copy of the donor's consent under section 16 of the Act or evidence that the donor has provided the relevant consent;
o the donor of the gametes, or each person who donated the gametes used to produce the embryo, has consented in writing to the donor's gametes or embryo produced from the donor's gametes being taken from Victoria;
o I have been given a copy of the donor's consent or the consent of each person who donated the gametes used to produce the embryo, to take the donor's gametes or the embryo from Victoria;
o I have sighted—
· the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature; or
· a certified copy of the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature;
o I have provided the receiving party with the following information about the donor—
(a)the donor's unique donor identifier (if any);
(b)the donor's full name;
(c)any other name by which the donor is or has been known;
(d)the donor's date of birth;
(e)the donor's place of birth (suburb or town and country);
(f)the donor's sex;
(g)the donor's residential address;
(h)the donor's phone number;
(i)the date on which the donor produced the gametes;
(j)the place at which the donor produced the gametes;
(k)the donor's blood group;
(l)any known genetic abnormality of the donor and, if available, any results of tests undertaken in relation to that abnormality;
(m)the number of women who have given birth to children conceived using the donor's gametes or an embryo produced from the donor's gametes, including any current or former partner of the donor;
(n)whether the donor has donated, or intends to donate, gametes or an embryo to any other registered ART provider or to a doctor and, if so—
(i)the name and address of that registered ART provider; or
(ii)the full name and business address of that doctor;
o [*if the person making the certification is a registered ART provider and the donor gametes were or the embryo produced from the donor's gametes was not produced at the premises of the registered ART provider] I have provided the receiving party with the date on which the gametes were or the embryo was received by me;
o [*if the person making the certification is a registered ART provider] I have provided the receiving party with the following information about the donor—
(a)the date on which I have sighted—
(i)the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature; or
(ii)a certified copy of the donor's passport, driver licence or any other identification document displaying the donor's photograph and signature;
(b)the number of children born as a result of a treatment procedure carried out by me using the donor's gametes or an embryo produced from the donor's gametes;
o [*if the person making the certification is a doctor carrying out artificial insemination other than on behalf of a registered ART provider using the donor gametes] I have provided the receiving party with the following information about the donor—
(a)the date on which the donor gametes were received by me;
(b)the date on which the donor received counselling under section 18 of the Act and the name of the counsellor who provided the counselling;
(c)the number of children born as a result of artificial insemination carried out by me using the donor's gametes;
o I have received the name and contact details of the receiving party;
o I have provided written notice to the donor of the name and contact details of the receiving party;
o I have taken all reasonable steps to ensure that at the time of certification, the limit imposed by section 29 of the Act in relation to the use of the *donor gametes/*embryo produced from donor gametes has not been reached.
Details
At the time of making this certification, the following details about the *donor gametes/*embryo produced from donor gametes to be taken from Victoria are accurate—
[specify the following details]
(a)contact details of person making the certification, including telephone number and address;
(b)if relevant, the name and contact details of the registered ART provider;
(c)the unique donor identifier(s);
(d)details about the *donor gametes/*embryo produced from donor gametes, including—
(i)number of vials, straws or containers of donor sperm; and
(ii)number of donor oocytes; and
(iii)number of embryos produced from donor gametes;
(e)details of the proposed transport or movement of the *donor gametes/*embryo produced from donor gametes, including—
(i)the name and contact details of the receiving party including the country in which the receiving party is located; and
(ii)the date or proposed date of movement of the *donor gametes/*embryo produced from donor gametes from Victoria; and
(iii)the method of transportation.
Declaration
I acknowledge that providing information that I know or believe to be false or misleading is an offence.
Signed: [signature of person making certification]
Name: [print name]
Date:
Witness signed: [signature of witness]
Witness name: [print name]
Date:
*Delete if inapplicable.
Notes
1.Section 36(4) of the Act provides the matters that a person must certify before a person takes donor gametes or an embryo produced from donor gametes from Victoria.
2.Regulation 9D of the Assisted Reproductive Treatment Regulations 2019 prescribes the additional matters that a person making a certification must satisfy for the purposes of section 36(4)(c) of the Act.".
12New Schedule 11 inserted
After Schedule 10 to the Principal Regulations insert—
"Schedule 11—Infringement offences
Section 116P of the Assisted Reproductive Treatment Act 2008
Regulation 25
Table
| Item | Column 1 Prescribed offence | Column 2 Prescribed infringement penalty |
| 1 | Section 37B(2) | In the case of a natural person, 10 penalty units In the case of a body corporate, 40 penalty units |
| 2 | Section 49(1) | 10 penalty units |
| 3 | Section 49(2) | 10 penalty units |
| 4 | Section 51(1) | 2 penalty units |
| 5 | Section 55(3) | 8 penalty units |
| 6 | Section 55A(3) | 8 penalty units |
| 7 | Section 66A(1) | 8 penalty units |
| 8 | Section 66B(1) | 8 penalty units |
| 9 | Section 66C(1) | 8 penalty units |
| 10 | Section 80(1) | 8 penalty units |
| 11 | Section 112 | In the case of a natural person, 12 penalty units In the case of a body corporate, 60 penalty units |
| 12 | Section 116B | In the case of a natural person, 12 penalty units In the case of a body corporate, 60 penalty units |
| 13 | Section 116K | In the case of a natural person, 10 penalty units In the case of a body corporate, 40 penalty units |
| 14 | Section 120 | 8 penalty units |
| 15 | Section 121 | 8 penalty units |
".
═════════════
ENDNOTES
[1] Reg. 4: S.R. No. 115/2019 as amended by S.R. Nos 64/2020, 60/2022 and 141/2024.
——
Penalty Units
These Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the Sentencing Act 1991. The amount of the penalty is to be calculated, in accordance with section 7 of the Monetary Units Act 2004, by multiplying the number of penalty units applicable by the value of a penalty unit.
The value of a penalty unit for the financial year commencing 1 July 2025 is $203.51. The amount of the calculated penalty may be rounded to the nearest dollar.
The value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.
0
0
0