Animal Research Act 1985 No 123
Current version for 1 January 2014 to date (accessed 19 December 2014 at 14:57)
Part 4

Part 4 Accreditation and licensing

Division 1 Interpretation

17   Definitions

(1)  In this Part:

approved means approved for the time being by the Director-General.

disqualified corporation means a corporation that:

(a)  has, within the previous 3 years, been convicted of an offence arising under Part 5 of this Act or Part 2 of the Prevention of Cruelty to Animals Act 1979, or
(b)  has a disqualified individual as one of its directors.

disqualified individual means an individual who:

(a)  has, within the previous 3 years, been convicted of an offence arising under Part 5 of this Act or Part 2 of the Prevention of Cruelty to Animals Act 1979, or
(a1)  was the holder of an animal research authority or animal supplier’s licence that was cancelled by the Director-General within the previous 12 months, or
(b)  is a director of a disqualified corporation.

(2)  In this Part, a reference to an animal care and ethics committee in relation to an animal research authority is a reference to the animal care and ethics committee specified in the authority.

Division 2 Accreditation of research establishments

18   Applications for accreditation

(1)  A corporation may apply to the Director-General for accreditation as a research establishment.
(2)  An application shall:
(a)  be in or to the effect of the approved form,
(b)  include the prescribed particulars,
(c)  identify the land in or on which the applicant intends to carry on the business of animal research,
(d)  be accompanied by the prescribed fee, and
(e)  be lodged at the office of the Director-General.

19   Investigation of applications

(1)  The Director-General shall refer all applications to the Panel for investigation.
(2)  The Panel shall investigate each application referred to it and shall furnish the Director-General with a report on each such application.

20   Determination of applications

(1)  After considering the Panel’s report on an application, the Director-General shall determine the application:
(a)  by accrediting the applicant as a research establishment, either unconditionally or subject to conditions, or
(b)  by refusing to accredit the applicant as a research establishment.
(2)  Notwithstanding subsection (1), the Director-General shall not accredit an applicant as a research establishment:
(a)  if the applicant does not have a duly constituted animal care and ethics committee, or
(b)  if the applicant is a disqualified corporation.
(3)  Where the Director-General refuses to accredit an applicant as a research establishment, the Director-General shall, as soon as practicable after so refusing, cause notice of the refusal, and of the reasons for the refusal, to be served on the applicant.
(4)  If, at the expiration of 90 days after an application has been made, the Director-General has failed to determine the application, the Director-General is, for the purposes only of any application to the Civil and Administrative Tribunal for an administrative review, taken to have refused to accredit the applicant as a research establishment.
(5)  The Director-General shall issue a certificate of accreditation to each corporation that the Director-General accredits as a research establishment.
(6)  A certificate of accreditation in respect of an accredited research establishment shall:
(a)  be in or to the effect of the approved form,
(b)  designate the land in or on which it is intended that the business of animal research will be carried on by the establishment, as identified in the application pursuant to which the establishment has been accredited,
(c)  specify any condition to which the accreditation is subject, and
(d)  specify the date on which the accreditation was granted.

21   Duration of accreditation

(1)  Unless sooner cancelled, an accreditation remains in force as follows:
(a)  if the research establishment has not been accredited before—12 months from the date on which the accreditation is granted,
(b)  if the research establishment has been accredited before and during the last period of accreditation the accreditation was cancelled or suspended—12 months from the date on which the accreditation is granted or such lesser period as the Director-General determines,
(c)  if the research establishment has been accredited before and paragraph (b) does not apply—36 months from the date on which the accreditation is granted.
(2)  Notwithstanding subsection (1), the accreditation of a research establishment has no force or effect during any period for which it is suspended.

22   Complaints

(1)  A complaint in respect of an accredited research establishment may be made to the Director-General:
(a)  that the establishment does not have a duly constituted animal care and ethics committee,
(b)  that animal research is being or has been carried out on behalf of the establishment:
(i)  by an individual who is not the holder of an animal research authority issued by the establishment,
(ii)  otherwise than with the approval, or in contravention of the directions, of the animal care and ethics committee for the establishment,
(iii)  in contravention of the Code of Practice,
(iv)  otherwise than for a recognised research purpose, or
(v)  in connection with animals (other than exempt animals) that have not been obtained from the holder of an animal supplier’s licence,
(c)  that the establishment is a disqualified corporation, or
(d)  that the establishment has failed to comply with a condition to which its accreditation is subject.
(2)  A complaint shall:
(a)  be in writing,
(b)  specify the grounds on which it is made,
(c)  be signed by the complainant, and
(d)  be lodged at the office of the Director-General.

23   Investigation of complaints

(1)  The Director-General shall refer all complaints to the Panel for investigation.
(2)  The Panel shall investigate each complaint referred to it and shall furnish the Director-General with a report on each such complaint.

24   Determination of complaints

(1)  After considering the Panel’s report on a complaint, the Director-General shall determine the complaint:
(a)  by cancelling the accreditation of the research establishment the subject of the complaint,
(b)  by suspending the accreditation of the research establishment the subject of the complaint for such period as the Director-General thinks fit,
(c)  by cautioning or reprimanding the research establishment the subject of the complaint, or
(d)  by dismissing the complaint.
(2)  The Director-General shall not cancel or suspend the accreditation of a research establishment unless:
(a)  notice has been served on the establishment:
(i)  of the Director-General’s intention to cancel or suspend the accreditation, and
(ii)  of the reasons for which the Director-General intends to cancel or suspend the accreditation,
(b)  the establishment has had a reasonable opportunity to make submissions to the Director-General in relation to the intended cancellation or suspension of the accreditation, and
(c)  the Director-General has considered any such submission.
(3)  As soon as practicable after determining a complaint, the Director-General shall cause written notice of the determination to be served on:
(a)  the research establishment the subject of the complaint, and
(b)  the complainant.
(4)  The cancellation or suspension of accreditation of a research establishment takes effect at the expiration of 14 days after written notice of the cancellation or suspension is served on the establishment, subject to any order made by the Civil and Administrative Tribunal under Division 2 of Part 3 of Chapter 3 of the Administrative Decisions Review Act 1997.

Division 3 Animal research authorities

25   Authorities may be issued by Director-General and accredited research establishments

(1)  The Director-General or an accredited research establishment may issue an authority to any individual to carry out animal research for the purpose of a particular research project.
(2)  The Director-General may issue an animal research authority only on the recommendation of an animal care and ethics committee.
(3)  An accredited research establishment may issue an animal research authority only on the recommendation of its animal care and ethics committee.
(4)  An animal research authority is not to be issued to a disqualified individual.

25A   Application to Director-General

(1)  An individual may apply to the Director-General for an animal research authority.
(2)  The application must:
(a)  be in or to the effect of the approved form, and
(b)  include such particulars of the research project in connection with which the animal research is to be carried out as may be prescribed by the regulations, and
(c)  include particulars of any application made to an accredited research establishment for an animal research authority in respect of the same project and of any refusal of such an application, and
(d)  identify the land in or on which the applicant intends to carry out the animal research, and
(e)  include particulars of any cancellation of any animal research authority or animal supplier’s licence previously held by the applicant, and
(f)  be accompanied by the fee prescribed by the regulations, and
(g)  be lodged at the office of the Director-General.
(3)  Subject to section 25, the Director-General is to determine an application:
(a)  by issuing the authority to the applicant, or
(b)  by refusing to issue an authority to the applicant.
(4)  If the Director-General refuses to issue an authority, the Director-General is, as soon as practicable after so refusing, to cause notice of the refusal, and of the reasons for the refusal, to be served on the applicant for the authority.
(5)  If, at the expiration of 90 days after an application has been made, the Director-General has failed to determine the application, the Director-General is, for the purposes only of any application to the Civil and Administrative Tribunal for an administrative review, taken to have refused to grant an authority to the applicant.

25B   Applications to accredited research establishments

(1)  An individual may apply to an accredited research establishment for an animal research authority.
(2)  The application must:
(a)  include such particulars of the research project in connection with which the animal research is to be carried out as may be prescribed by the regulations, and
(b)  include particulars of any application made to the Director-General or another accredited research establishment for an animal research authority in respect of substantially the same project and any refusal of such an application, and
(c)  identify the land in or on which the applicant intends to carry out the animal research, and
(d)  include particulars of any cancellation of any animal research authority or animal supplier’s licence previously held by the applicant, and
(e)  otherwise be made in the form and manner approved by the accredited research establishment.
(3)  Subject to section 25, an accredited research establishment may determine an application by issuing an animal research authority or refusing to issue an animal research authority.

25C   Applications by independent researchers

(1)  An accredited research establishment may charge a fee in respect of an application for an animal research authority (including an application for renewal of an animal research authority) that is made by an independent researcher.
(2)  The maximum fee that may be charged is the amount prescribed by the regulations as the maximum application fee.
(3)  An accredited research establishment must ensure that a record is kept for the period prescribed by the regulations that includes the particulars prescribed by the regulations of all applications for animal research authorities that are made to it by independent researchers during each reporting period.

Maximum penalty: 30 penalty units.

(4)  An accredited research establishment that makes a record under this section must give a copy of the record to the Director-General within one month after the end of the reporting period to which the record relates.

Maximum penalty: 30 penalty units.

(5)  In this section:

independent researcher, in relation to an accredited research establishment, means a person who carries out animal research, or applies for an authority to carry out animal research, otherwise than on behalf of the accredited research establishment.

reporting period means the period commencing on the commencement of this section and ending on 31 December in the same year and each subsequent period of 12 months.

26   Form of authorities

(1)  An animal research authority shall:
(a)  be in or to the effect of the approved form,
(b)  identify the person who issued the authority,
(c)  identify the person to whom the authority is issued,
(c1)  designate the land in or on which it is intended that the business of animal research will be carried on by the person,
(d)  describe the kind of animal research which the authority authorises the person to carry out and the research project in connection with which the person is authorised to carry out animal research,
(d1)  specify the animal care and ethics committee under whose supervision the individual is authorised to carry out animal research,
(d2)  specify any conditions to which the authority is subject, and
(e)  specify the date on which the authority is issued.
(2)  An animal research authority shall not authorise, or purport to authorise, the carrying out of animal research otherwise than:
(a)  with the approval, and in accordance with the directions, of the animal care and ethics committee specified in the authority,
(b)  in accordance with the Code of Practice,
(c)  for a recognised research purpose, and
(d)  in connection with animals (other than exempt animals) that have been obtained from the holder of an animal supplier’s licence.
(3)  Without limiting subsection (2), an animal research authority shall not authorise, or purport to authorise, the carrying out of the LD50 test for the purpose of product testing, or the carrying out of the Draize test, except with the approval, and in accordance with the directions, of the animal care and ethics committee specified in the authority, given in accordance with subsection (4).
(4)  An animal care and ethics committee shall not approve the carrying out, by the holder of an animal research authority, of:
(a)  the LD50 test for the purpose of product testing, except with the concurrence of the Minister, given on a recommendation for concurrence by the Panel, to the carrying out of the test for that purpose, or
(b)  the Draize test, unless the test is to be carried out for the sole purpose of establishing that prophylactic or therapeutic materials or substances ordinarily intended for use by application to the eye are not irritants to the eye.
(5)  An application for the concurrence of the Minister under this section shall be made by the holder of the animal research authority in the form and manner determined by the Director-General.
(6)  The Minister shall refer the application to the Panel which shall, as soon as practicable, recommend to the Minister whether concurrence should be granted, unconditionally or subject to conditions, or refused.
(7)  In considering the application, the Minister and the Panel shall have regard to the Code of Practice.
(8)  The Minister may grant concurrence under subsection (4) unconditionally or subject to conditions and may impose conditions in addition to any recommended by the Panel.

27   Duration of authorities

Unless sooner cancelled, an animal research authority remains in force for the period of 12 months from the date on which it was issued or, where a shorter period is specified in the authority in that regard, for the shorter period so specified.

28   Complaints

(1)  The following complaints about the holder of an animal research authority may be made to the Director-General:
(a)  that the holder of the authority is carrying out or has carried out animal research:
(i)  otherwise than as authorised by the authority, or
(ii)  otherwise than with the approval, or in contravention of the directions, of the animal care and ethics committee specified in the authority, or
(iii)  in contravention of the Code of Practice, or
(iv)  otherwise than for a recognised research purpose, or
(v)  in connection with animals (other than exempt animals) that have not been obtained from a licensed animal supplier,
(b)  that the holder of the authority is a disqualified individual,
(c)  that the holder of the authority has failed to comply with a condition to which the authority is subject.
(2)  A complaint must:
(a)  be in writing, and
(b)  specify the grounds on which it is made, and
(c)  be signed by the complainant, and
(d)  be lodged at the office of the Director-General.

28A   Investigation of complaints

(1)  The Director-General is to refer all complaints to the Panel for investigation.
(2)  The Panel is to investigate each complaint referred to it and furnish a report to the Director-General on each such complaint.

28B   Determination of complaints

(1)  After considering a report furnished in respect of a complaint, the Director-General is to determine the complaint:
(a)  by cancelling the authority the subject of the complaint, or
(b)  by suspending the authority the subject of the complaint for such period as the Director-General thinks fit, or
(c)  by cautioning or reprimanding the holder of the authority the subject of the complaint, or
(d)  by dismissing the complaint.
(2)  The Director-General is not to cancel or suspend an authority unless:
(a)  notice has been served on the holder of the authority:
(i)  of the Director-General’s intention to cancel or suspend the authority, and
(ii)  of the reasons for which the Director-General intends to cancel or suspend the authority, and
(b)  the holder of the authority has had a reasonable opportunity to make submissions to the Director-General in relation to the intended cancellation or suspension of the authority, and
(c)  the Director-General has considered any such submission.
(3)  As soon as practicable after determining a complaint, the Director-General is to cause written notice of the determination to be served on:
(a)  the holder of the authority the subject of the complaint, and
(b)  the complainant.
(4)  The cancellation or suspension of accreditation of an authority takes effect at the expiration of 14 days after written notice of the cancellation or suspension is served on the holder of the authority, subject to any order made by the Civil and Administrative Tribunal under Division 2 of Part 3 of Chapter 3 of the Administrative Decisions Review Act 1997.
(5)  For avoidance of doubt, an authority may be cancelled or suspended by the Director-General under this section whether or not the Director-General issued the authority.
(6)  As soon as practicable after cancelling an authority, the Director-General is to cause notice of the cancellation to be given to each accredited research establishment.

28C   Cancellation of authority by research establishment

An animal research authority that was issued by an accredited research establishment may be cancelled at any time by the accredited research establishment.

Division 4

29–36(Repealed)

Division 5 Animal suppliers’ licences

37   Applications for licences

(1)  A person may apply to the Director-General for an animal supplier’s licence.
(2)  An application shall:
(a)  be in or to the effect of the approved form,
(b)  include the prescribed particulars,
(c)  identify the land (being land occupied or to be occupied by the applicant) in or on which the applicant intends to conduct the supply of animals for use in connection with animal research,
(d)  be accompanied by the prescribed fee, and
(e)  be lodged at the office of the Director-General.

38   Investigation of applications

(1)  The Director-General shall refer all applications to the Panel for investigation.
(2)  The Panel shall investigate each application referred to it and shall furnish the Director-General with a report on each such application.

39   Determination of applications

(1)  After considering the Panel’s report on an application, the Director-General shall determine the application:
(a)  by granting a licence to the applicant, either unconditionally or subject to conditions, or
(b)  by refusing to grant a licence to the applicant.
(2)  Despite subsection (1), the Director-General is not to grant an animal supplier’s licence to an applicant:
(a)  if the applicant does not have a duly constituted animal care and ethics committee, or
(b)  if the applicant is a disqualified individual or a disqualified corporation.
(3)  Where the Director-General refuses to grant a licence, the Director-General shall, as soon as practicable after so refusing, cause notice of the refusal, and of the reasons for the refusal, to be served on the applicant for the licence.
(4)  If, at the expiration of 90 days after an application has been made, the Director-General has failed to determine the application, the Director-General is, for the purposes only of any application to the Civil and Administrative Tribunal for an administrative review, taken to have refused to grant a licence to the applicant.

40   Form of licences

(1)  An animal supplier’s licence shall:
(a)  be in or to the effect of the approved form,
(b)  identify the person to whom the licence is granted,
(c)  designate the land in or on which it is intended that the supply of animals for use in connection with animal research will be conducted by the person, as identified in the application pursuant to which the person has been granted the licence,
(d)  describe the kind of animals which the licence authorises the person to supply,
(e)  specify any condition to which the licence is subject, and
(f)  specify the date on which the licence is granted.
(2)  An animal supplier’s licence is not to authorise, or purport to authorise, the supply of animals otherwise than:
(a)  with the approval, and in accordance with the directions, of the animal care and ethics committee for the animal supplier, and
(b)  in accordance with the Code of Practice.

41   Duration of licences

(1)  Unless sooner cancelled, an animal supplier’s licence remains in force for the period of 36 months from the date on which it was granted or, where a shorter period is specified in the licence in that regard, for the shorter period so specified.
(2)  Notwithstanding subsection (1), an animal supplier’s licence has no force or effect during any period for which it is suspended.

42   Complaints

(1)  A complaint in respect of an animal supplier’s licence may be made to the Director-General:
(aa)  that the holder of the licence does not have a duly constituted animal care and ethics committee,
(a)  that the holder of the licence is supplying or has supplied animals for use in connection with animal research:
(i)  otherwise than as authorised by the licence, or
(ia)  otherwise than with the approval, or in contravention of the directions, of the animal care and ethics committee for the animal supplier, or
(ii)  in contravention of the Code of Practice,
(b)  that the holder of the licence is a disqualified individual or a disqualified corporation, or
(c)  that the holder of the licence has failed to comply with a condition to which the licence is subject.
(2)  A complaint shall:
(a)  be in writing,
(b)  specify the grounds on which it is made,
(c)  be signed by the complainant, and
(d)  be lodged at the office of the Director-General.

43   Investigation of complaints

(1)  The Director-General shall refer all complaints to the Panel for investigation.
(2)  The Panel shall investigate each complaint referred to it and shall furnish a report to the Director-General on each such complaint.

44   Determination of complaints

(1)  After considering a report furnished in respect of a complaint, the Director-General shall determine the complaint:
(a)  by cancelling the licence the subject of the complaint,
(b)  by suspending the licence the subject of the complaint for such period as the Director-General thinks fit,
(c)  by cautioning or reprimanding the holder of the licence the subject of the complaint, or
(d)  by dismissing the complaint.
(2)  The Director-General shall not cancel or suspend a licence unless:
(a)  notice has been served on the holder of the licence:
(i)  of the Director-General’s intention to cancel or suspend the licence, and
(ii)  of the reasons for which the Director-General intends to cancel or suspend the licence,
(b)  the holder of the licence has had a reasonable opportunity to make submissions to the Director-General in relation to the intended cancellation or suspension of the licence, and
(c)  the Director-General has considered any such submission.
(3)  As soon as practicable after determining a complaint, the Director-General shall cause written notice of the determination to be served on:
(a)  the holder of the licence the subject of the complaint, and
(b)  the complainant.
(4)  The cancellation or suspension of a licence takes effect:
(a)  except as provided by paragraph (b)—at the expiration of 14 days after written notice of the cancellation or suspension is served on the holder of the licence, or
(b)  where an appeal is made before the expiration of the period referred to in paragraph (a)—when the appeal is withdrawn or otherwise finally disposed of.

Division 6 Administrative reviews by Civil and Administrative Tribunal

45   Applications to Civil and Administrative Tribunal for administrative review of determination

(1)  Any person who is dissatisfied with a determination of the Director-General under this Part that affects the person may apply to the Civil and Administrative Tribunal for an administrative review under the Administrative Decisions Review Act 1997 of the determination.
(2)  An application to the Tribunal is to be made within 28 days after written notice of the determination of the Director-General is served on the person or, if the application relates to a failure to determine an application under this Part within 90 days after the application was made, within 28 days after the expiration of that 90 day period.
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