Human Reproductive Technology Act 1991
Human Reproductive Technology (Licences and Registers) Regulations 1993
Reprint 1: The regulations as at 11 March 2005
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Human Reproductive Technology (Licences and Registers) Regulations 1993
CONTENTS
1. Citation1
2. Exemptions relating to artificial insemination1
3. Applications for licences2
4. Registers of identity, etc.3
5. Authorised officers5
Schedule6
Notes
Compilation table10
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Reprinted under the Reprints Act 1984 as |
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at 11 March 2005 |
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Human Reproductive Technology Act 1991
Human Reproductive Technology (Licences and Registers) Regulations 1993
These regulations may be cited as the Human Reproductive Technology (Licences and Registers) Regulations 1993 1.
2. Exemptions relating to artificial insemination
(1)An application by a medical practitioner for exemption under section 28(1) of the Act in respect of artificial insemination procedures shall be —
(a)lodged with the Health Department of Western Australia 2;
(b)in writing, substantially in accordance with Form 1 in the Schedule, and containing the undertaking prescribed in that Form;
(c)accompanied by —
(i)a fee of $50; and
(ii)evidence of the medical qualification of the applicant;
(d)signed by the applicant.
(2)A certificate of exemption in respect to which conditions are to be imposed shall be issued under section 28(1) of the Act in Form 2 in the Schedule.
(3)Where an artificial insemination procedure is carried out by a person, other than by a medical practitioner, no licence or exemption under the Act is required if the person carrying out the procedure —
(a)is acting under the direction of a licensee; and
(b)where donor sperm is used, has given in writing an undertaking to the licensee directing the procedure to furnish to that licensee such detail as may be possible, and is required by that licensee, of the outcome of the procedure.
(1)An application for a licence, or for the renewal of a licence, shall be lodged with the Health Department of Western Australia 2.
(2)An application for a practice licence shall be accompanied by a fee of $500.
(3)An application for a storage licence shall be accompanied by a fee —
(a)if —
(i)sperm is not to be collected at the premises to which the licence relates; or
(ii)the sperm which is to be collected there is not intended for use in donor insemination,
of $100;
(b)if sperm intended for use in donor insemination is to be collected at the premises to which the licence relates, of $300; and
(c)if eggs or embryos are to be stored, of $300.
4. Registers of identity, etc.
(1)For the purpose of a register required to be kept under section 45(1)(b)(i) of the Act, the prescribed information to be shown in respect of a licence is —
(a)the full name and address of the licensee;
(b)the kind of licence;
(c)the date of grant, the date of expiry;
(d)any date from which the operation of the licence was, is, or is to be suspended, and the period of suspension ordered;
(e)each condition, term or matter currently and specifically applicable, whether as required by section 27(4)(a)(ii), (iii) and (iv) or by any condition, term or matter subsequently imposed, or as varied, and the period for which it is to apply;
(f)the full name and address of the person responsible, and of any person approved as a manager or as temporarily responsible, specifying the period applicable;
(g)the address of the premises to which the licence relates, containing such detail as is sufficient to identify those premises; and
(h)the date, and the outcome, of any monitoring or review.
(2)For the purpose of a register required to be kept under section 45(1)(b)(ii) of the Act, the prescribed information to be shown in respect to persons to whom an exemption under section 28 of the Act applies is —
(a)the full name and address of the holder of the exemption;
(b)the kind of procedures to which the exemption relates;
(c)the date the exemption takes effect;
(d)the date of issue of any certificate of exemption;
(e)any date from which the operation of any exemption deemed to have been or specifically issued was, is, or is to be suspended, and the period of suspension ordered;
(f)each condition currently and specifically applicable, and the period for which it is to apply;
(g)the full name and address of the person responsible; and
(h)if the exemption, or any condition, relates to specific premises the address of those premises containing such detail as is sufficient to identify those premises.
(3)For the purpose of the register required to be kept under section 45(1)(d) of the Act, the prescribed requirements to be shown in relation to any disciplinary proceedings are —
(a)the name of the licensee or other person to whom the proceedings relate;
(b)the kind of licence, and the premises, to which the proceedings relate;
(c)the nature of the matters alleged as requiring disciplinary action;
(d)each kind of disciplinary action taken, and the date on which it was taken;
(e)whether any, and what, summary determination was made, consent given or cause shown;
(f)whether any, and what, warning or penalty was imposed by the Commissioner summarily;
(g)the nature of any allegation made to the State Administrative Tribunal by the Commissioner;
(h)the outcome of any allegation to the State Administrative Tribunal, including any penalty imposed by the Tribunal; and
[(j), (k) deleted]
(l)the nature, and outcome, of any review by the State Administrative Tribunal.
(4)The Commissioner of Health shall cause to be kept, in a place and manner approved by the Minister, registers containing information relating to —
(a)the export from the State of gametes, eggs in the process of fertilisation or embryos; and
(b)the subsequent use, or other dealing in or disposal, of the exported material,
as may be required to be supplied by any provision of the Code, by a direction given under section 31(1)(b), or by a condition imposed under any such provision or direction.
[Regulation 4 amended in Gazette 12 May 1995 p. 1775; 30 Dec 2004 p. 6939.]
The certificate of identity to be issued to an authorised officer or other person to whom section 59(2) of the Act applies shall show —
(a)the full name, and a photograph of the face, of that person;
(b)whether that person —
(i)is generally authorised for the purposes of the Act;
(ii)is authorised only for specific named functions or in particular circumstances; and
(iii)is, or is not, to be given right of access to participant identifying information;
(c)the signature of the holder; and
(d)the signature of the Commissioner, and the date of issue,
on a background clearly stating the name of the Act, and identifying an officer of the Health Department 2 of whom inquiries may be made.
FORM 1
[Reg. 2(1)]
HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991
HUMAN REPRODUCTIVE TECHNOLOGY (LICENCES AND REGISTERS) REGULATIONS 1993
APPLICATION FOR EXEMPTION IN RESPECT OF ARTIFICIAL INSEMINATION PROCEDURES
I ..............................................................................................................................
(Full name of applicant)
of ............................................................................................................................
(Address, fax. and telephone number of applicant)
being a licensed medical practitioner, hereby apply for an exemption from the licensing requirements of the Human Reproductive Technology Act 1991 in respect of the carrying out of artificial insemination procedures of the following kind —
................................................................................................................. (Specify)
I understand that the conditions specified in s. 33 of the Act will apply to this exemption.
I undertake —
(a)to observe and comply with —
(i)the Code of Practice; and
(ii)any direction from the Commissioner of Health,
in so far as it relates to any relevant artificial insemination procedure;
(b)to furnish such detail as is possible and may be required to —
(i)the storage licensee from whom sperm was obtained; or
(ii)if the sperm was not obtained from a storage licensee, the Commissioner of Health,
of the outcome of each procedure I perform, or authorise, involving donor insemination;
and
(c)to comply with any requirement made under the Act as to the obtaining of effective consent from participants.
Signed .........................................Date ............./............./.............
For further information contact:
Coordinator/Reproductive Technology
Health Department of
189 Royal Street
Phone (08) 9222 4260
Fax (08) 9222 4236
FORM 2
[Reg. 2(2)]
HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991
HUMAN REPRODUCTIVE TECHNOLOGY (LICENCES AND REGISTERS) REGULATIONS 1993
EXEMPTION IN RESPECT OF ARTIFICIAL INSEMINATION PROCEDURES
This certificate of exemption is issued in accordance with section 28(1) of the
Act to ......................................................................................................................
(Full name of holder)
of ............................................................................................................................
(Address of holder)
.................................................................................................................................
who, as the person responsible for the supervision of all practices related to the procedures, has been granted an EXEMPTION from the requirement of the Act to be licensed to carry out ARTIFICIAL INSEMINATION PROCEDURES of the kind listed below —
................................................................................................................................
................................................................................................................................
................................................................................................................................
................................................................................................................................
................................................................................................................................
subject, in addition to the conditions specified in s. 33 of the Act, to the following specific conditions —
................................................................................................................................
................................................................................................................................
................................................................................................................................
................................................................................................................................
................................................................................................................................
........................................................................
Signed (Commissioner of Health)
For information contact:
Coordinator/Reproductive Technology
Health Department of
189 Royal Street
Phone (08) 9222 4260
Fax (08) 9222 4236
1This reprint is a compilation as at 11 March 2005 of the Human Reproductive Technology (Licences and Registers) Regulations 1993 and includes the amendments made by the other written laws referred to in the following table. The table also contains information about any reprint.
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Citation |
Gazettal |
Commencement |
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Human Reproductive Technology (Licences and Registers) Regulations 1993 |
19 Mar 1993 p. 1642‑6 |
19 Mar 1993 |
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Human Reproductive Technology (Licences and Registers) Amendment Regulations 1995 |
12 May 1995 p. 1775 |
12 May 1995 |
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Human Reproductive Technology (Licences and Registers) Amendment Regulations 2004 |
30 Dec 2004 p. 6939 |
1 Jan 2005 (see r. 2 and Gazette 31 Dec 2004 p. 7130) |
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Reprint 1: The Human Reproductive Technology (Licences and Registers) Regulations 1993 as at 11 Mar 2005 (includes amendments listed above) |
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2Under the Alteration of Statutory Designations Amendment Order 2001 a reference in any law to the Health Department of Western Australia is read and construed as a reference to the Department of Health.
By Authority: JOHN A. STRIJK, Government Printer