ORGANIZACION MUNDIAL 
DEL COMERCIO 
Consejo de los Aspectos de los Derechos de 
Propiedad Intelectual relacionados con el Comercio RESTRICTED 
IP/NIlINZL/UI 1 
26 de enero de 1996 
(96-0246) 
Original: ingles 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL pARRAFO 2 DEL ARTICULO 63 DEL ACUERDO 
Nueva Zelandia 
Protecci6n de la informaci6n no divulgada 
En el presente documento se reproducenl las leyes y reglamentos siguientes, notificados por 
Nueva Zelandia en virtud de 10 dispuesto en el parrafo 2 del articulo 63 del Acuerdo (vease el documento 
IP/NllINZL/1): 
Ley de Modificaci6n de la Ley de Sanidad Animal, de 1994 2 
Ley de Modificaci6n de la Ley de Plaguicidas, de 1994 7 
Ley de Modificaci6n de la Ley de Medicamentos, de 1994 12 
IEn ingles solamente. IP IN 11 INZL/U 11 
Page 2 
1994 Animal Remedies Amendment No. 126 
Title 
1. Short Title and commencement 
2. New Part inserted 
PART HA 
PROTECTION OF CERTAIN 
CONFIDENTIAL INFORMATION 
ABOUT INNOVATIVE ANIMAL 
REMEDIES 
35A. Interpretation ANALYSIS 
35B. Protection of confidential sup· 
porting information about 
innovative animal remedies 
35c. Circumstances where protec· 
tion under section 35B does 
not apply 
3. Publication of results of analyses and 
details of animal remedies 
4. Regulations 
1994, No. 126 
An Act to alTlend the AnilTlal RelTledies Act 1967 
[9 December 1994 
BE IT ENACTED by the Parliament of New Zealand as follows: 
1. Short Title and cOlTllTlencelTlent-( 1) This Act may be 
cited as the Animal Remedies Amendment Act 1 994, and shall 
be read together with and deemed part of the Animal 
Remedies Act 1 967 (hereinafter referred to as the principal 
Act). 
(2) This Act shall come into force on a date to be appointed 
by the Governor-General by Order in Council; and one or more 
orders may be made bringing different provisions into force on 
different dates. 
2. New Part inserted-The principal Act is hereby 
amended by inserting, after section 35, the following Part: 
"PART IIA 
"PROTECTION OF CERTAIN CONFIDENTIAL INFORMATION 
ABOUT INNOVATIVE ANIMAL REMEDIES 
"35A. Interpretation-In this Part of this Act, unless the 
context otherwise requires,-
" 'Applicant' means-
Public-126 Price Code: 5-BY 2 Animal Remedies Amendment IP/N/I/NZL/U/l 
Page 3 
1994, No. 126 
"(a) A person who makes or has made, as the case 
may be, an application; and 
"(b) A person on whose behalf an application is, or 
has been, made, as the case may be: 
" 'Application' means an application for the issue under 
section 2 1 of this Act of a licence or a provisional 
licence to manufacture or import, as the case may be, 
an animal remedy: 
"'Commencement date' means the date on which this 
Part of this Act comes into force: 
" 'Confidential information' includes-
"(a) Trade secrets; and 
"(b) Information that has commercial value that 
would be, or would be likely to be, diminished by 
disclosure: 
" 'Confidential supporting information' means confidential 
information given-
"(a) In, or in relation to, an innovative animal 
remedy application; and 
"(b) About the animal remedy that is or was, as the 
case may be, the subject of that application: 
" 'Ingredient' includes a chemical or biological entity: 
" 'Innovative animal remedy application' means,-
"(a) In relation to an application made after the 
commencement date, an application that refers to an 
active ingredient-
"(i) That is an active ingredient of the animal 
remedy to which the application relates; 
and 
"(ii) That has not, before that application is 
received by the Board, been referred to in 
any other application (except in an 
application by the applicant for a 
provisional licence for that animal remedy) 
as an active ingredient of an animal 
remedy; and 
"(b) In relation to an application made before the 
commencement date, an application that referred to 
an active ingredient-
"(i) That is or was, as the case may be, an active 
ingredient of the animal remedy to which 
the application related; and 
"(ii) That had not, before that application was 
received by the Board, been referred to in 
any other application (except in an IP/N/I/NZL/U/l 
Page 4 
1994, No. 126 Animal Remedies Amendment 3 
application by the applicant for a 
provisional licence for that animal remedy) 
as an active ingredient of an animal 
remedy: 
" 'Protected period' means,-
"(a) In relation to confidential supporting 
information, relating to an innovative animal remedy 
application, received by the Board after the 
commencement date, a period commencing on the 
date that information is received by the Board and 
ending,-
"(i) Where-
"(A) The Board has either issued a 
licence, not being a provisional licence, 
under section 21 of this Act, or refused to 
grant such licence, in relation to the 
animal remedy that is the subject of the 
innovative animal remedy application; and 
"(B) The date of that issue or refusal is 
not more than 5 years after the Board 
received an application in relation to that 
animal remedy,-
on the date 5 years after the date of that 
issue or refusal; or 
"(ii) In any other case, on the date 5 years after 
the innovative animal remedy application 
to which that information relates is or was, 
as the case may be, received by the Board: 
"(b) In relation to confidential supporting 
information, relating to an innovative animal remedy 
application, received by the Board not more than 
5 years before the commencement date, a period 
commencing on the commencement date and 
ending,-
"(i) Where-
"(A) The Board has either issued or 
issues a licence, not being a provisional 
licence, under section 21 of this Act, or 
refused or refuses to grant such licence, in 
relation to the animal remedy that was the 
subject of the innovative animal remedy 
application; and 
"(B) The date of that issue or refusal is 
or was, as the case may be, not more than 
5 years after the Board received an 4 A nimal Remedies Amendment IP/N/I/NZL/U/l 
Page 5 
1994, No. 126 
application in relation to that aniIllal 
remedy,-
on the date 5 years after the date of that 
issue or refusal; or 
"(ii) In any other case, on the date 5 years after 
the innovative animal rellledy application 
to which that information related was 
received by the Board: 
" 'WTO Country' means a country that is a party to the 
Agreement establishing the World Trade 
Organization adopted at Marrakesh on the 15th day 
of April 1994. 
"35B. Protection of confidential supporting 
infonnation about innovative anitnal retnedies-Where 
the Board receives, or received not more than 5 years before 
the commencement date, an innovative aniIllal remedy 
application and confidential supporting inforlllation, the Board, 
during the protected period in relation to that confidential 
supporting information,-
"(a) Shall take reasonable steps to ensure that that 
confidential supporting information IS kept 
confidential to the Board; and 
"(b) Shall not use that confidential supporting inforlllation 
for the purposes of deterlllining whether to grant 
any other application. 
"35c. CirculDstances where protection under section 
85B does not apply-( 1) Notwithstanding section 35B of this 
Act, the Board may, during the protected period in relation to 
confidential supporting information,-
"(a) Disclose that confidential supporting information, or use 
that confidential supporting inforrnation for the 
purposes of determining whether to grant any 
application other than the application to which it 
relates or related, as the case may be,-
"(i) With the consent of the applicant who made 
the application to which the confidential supporting 
information relates or related; or 
"(ii) If that disclosure or use is, in the opinion of 
the Board, necessary to protect the health or safety 
of members of the public; or 
"(b) Disclose that confidential supporting inforrnation to­
"(i) A Government departrnent or statutory body 
for the purposes of that Government department or 
statutory body: IP/N/I/NZL/U/l 
Page 6 
1994, No. 126 Animal Remedies Amendment 5 
"(ii) An adviser for the purposes of obtaining 
advice about the animal remedy to which the 
information relates,-
if, in the opinion of the Board, the Government 
department, statutory body, or adviser, as the case 
may be, will take reasonable steps to ensure the 
information is kept confidential; or 
"(c) Disclose that confidential supporting information to any 
one or more of the following: 
"(i) The World Health Organisation: 
"(ii) The Food and Agriculture Organisation: 
"(iii) The Office International des Epizooties: 
"(iv) A regulatory agency of a WTO country: 
"(v) A person or organisation, or a person or 
organisation within a class or classes of persons or 
organisations, approved by regulations made under 
this Act. 
"(2) The power to grant consent under subsection (1) (a) (i) of 
this section may be exercised by a person other than the 
applicant referred to in that subsection if-
"(a) That applicant-
"(i) Has notified the Board in wrltmg that that 
other person may grant that consent; and 
"(ii) Has not notified the Board in writing that that 
person's authority to grant that consent has been 
withdrawn; or 
"(b) That applicant's rights in respect of the relevant 
confidential supporting information have been 
transferred to that person and the applicant or that 
person has notified the Board of the transfer." 
3. Publication of results of analyses and details of 
aniD1.al reD1.edies-Section 55 of the principal Act is hereby 
aIllended by oIllitting the word "The', and substituting the 
words "Subject to Part IIA of this Act, the". 
4. Regulations-Section 65 of the principal Act is hereby 
aIllended by inserting, after paragraph (g), the following 
paragraph: 
"(ga) Approving persons or organisations, or classes of 
persons or organisations, for the purposes of section 
35c (1) (c) (v) of this Act: ". 
This Act is administered in the Ministry of Agriculture and Fisheries. 
WELLINGTON, NEW ZEALAND: Published under the authority of the 
New Zealand Governrnent-1994 
59516D-94/NS 1994 Pesticides Amendment 
ANALYSIS IP/NI1 INZL/UI 1 
Page 7 
No. 127 
Title 358. Protection of confidential sup­
porting information about 
innovative pesticides 1. Short Title and cornrnencement 
2. New Part inserted 
PART IlIA 
PROTECTION OF CERTAIN 
CONFIDENTIAL INFORMATION 
ABOUT INNOVATIVE PESTICIDES 
35A. Interpretation 35c. Circumstances where protec­
tion under section 358 does 
not apply 
35D. Protection of information 
about agricultural chemicals 
3. Regulations 
1994, No. 127 
An Act to atnend the Pesticides Act 1979 
[9 December 1994 
BE IT ENACTED by the Parliament of New Zealand as follows: 
1. Short Title and cOlTllTlencelTlent-( 1) This Act may be 
cited as the Pesticides Amendment Act 1 994, and shall be read 
together with and deemed part of the Pesticides Act 1 979 
(hereinafter referred to as the principal Act). 
(2) This Act shall come into force on a date to be appointed 
by the Governor-General by Order in Council; and one or more 
orders may be made bringing different provisions into force on 
different dates. 
2. New Part inserted-The principal Act is hereby 
amended by inserting, after section 35, the following Part: 
"PART IlIA 
"PROTECTION OF CERTAIN CONFIDENTIAL INFORMATION 
ABOUT INNOVATIVE PESTICIDES 
"35A. Interpretation-In this Part of this Act, unless the 
context otherwise requires,-
" 'Applicant' rneans-
"(a) A person who makes or has made, as the case 
may be, an application; and 
Public-127 Price Code: 5-BY IP/N/I/NZL/U/l 
Page 8 
2 Pesticides Amendment 1994, No. 127 
"(b) A person on whose behalf an application is, or 
has been, made, as the case may be: 
" 'Application' means an application for registration of a 
pesticide under section 22 of this Act or for an 
experimental use permit under section 25 of this Act: 
"'Commencement date' means the date on which this 
Part of this Act comes into force: 
" 'Confidential information' includes-
"(a) Trade secrets; and 
"(b) Information that has commercial value that 
would be, or would be likely to be, diminished by 
disclosure: 
" 'Confidential supporting information' rneans confidential 
information given-
"(a) In, or in relation to, an innovative pesticide 
application; and 
"(b) About the pesticide that is or was, as the case 
may be, the subject of that application: 
" 'Ingredient' includes a chemical or biological entity: 
" 'Innovative pesticide application' means-
"(a) In relation to an application made after the 
commencement date, an application that refers to an 
active ingredient-
"(i) That is an active ingredient of the pesticide 
to which the application relates; and 
"(ii) That has' not, before that application is 
. received by the Board, been referred to in 
any other application (except in an 
application by the applicant for an 
experimental use permit for that pesticide) 
as an active ingredient of a pesticide; and 
"(b) In relation to an application made before the 
commencement date, an application that referred to 
an active ingredient-
"(i) That is or was, as the case may be, an active 
ingredient of the pesticide to which the 
application related; and 
"(ii) That had not, before that application was 
received by the Board, been referred to in 
any other application (except in an 
application by the applicant for an 
experimental use permit for that pesticide) 
as an active ingredient of a pesticide: 1994, No. 127 Pesticides Amendment IP/N/l INZL/UI 1 
Page 9 
3 
" 'Protected period' rn.eans,-
"(a) In relation to confidential supporting 
inforrn.ation, relating to an innovative pesticide 
application, received by the Board after the 
corn.rn.encern.ent date, a period corn.rn.encing on the 
date that inforrn.ation is received by the Board and 
ending,-
"(i) Where-
"(A) The Board has either issued a 
certificate of registration under section 26 
of this Act, or refused to grant such 
certificate of registration, in relation to the 
pesticide that is the subject of the 
innovative pesticide application; and 
"(B) The date of that issue or refusal is 
not rn.ore than 5 years after the Board 
received an application in relation to that 
pesticide,-
on the date 5 years after the date of that 
issue or refusal; or 
"(ii) In any other case, on the date 5 years after 
the innovative pesticide application to 
which that inforrn.ation relates is or was, as 
the case rn.ay be, received by the Board: 
"(b) In relation to confidential supporting 
inforIllation, relating to an innovative pesticide 
application, received by the Board not Illore than 
15 years before the COIllIllencern.ent date, a period 
cOIllIllencing on the COIllIllencern.ent date and 
ending,-
"(i) Where the Board has issued or issues a 
certificate of registration under section 26 
of this Act, or refused or refuses to grant 
such certificate of registration, in relation 
to the pesticide that was the subject of the 
innovative pesticide application, on the 
earlier of the 2 following dates: 
"(A) The date ,15 years after the date of 
that issue or refusal: 
"(B) The date 5 years after the 
COIllIllencelllent date; or 
"(ii) In any other case, on the earlier of the 2 
following dates: 
"(A) The date 15 years after the 
innovative pesticide application to which 4 IP/N/l/NZL/U/l 
Page 10 
Pesticides Amendment 1994, No. 127 
that information related was received by 
the Board: 
"(B) The date 5 years after the 
commencement date: 
" 'WTO Country' means a country that is a party to the 
Agreement establishing the World Trade 
Organization adopted at Marrakesh on the 15th day 
of April 1994. 
"35B. Protection of confidential supporting 
infonnation about innovative pesticides-Where the 
Board receives, or received not more than 15 years before the 
commencement date, an innovative pesticide application and 
confidential supporting infonnation, the Board, during the 
protected period in relation to that confidential supporting 
information,-
"(a) Shall take reasonable steps to ensure that that 
confidential supporting information IS kept 
confidential to the Board; and 
"(b) Shall not use that confidential supporting information 
for the purposes of determining whether to grant 
any other application. 
"35c. CircuInstances where protection under 
section 85B does not apply-( 1) Notwithstanding section 35B 
of this Act, the Board lllay, during the protected period in 
relation to confidential supporting inforrnation,-
"(a) Disclose that confidential supporting infonnation, or use 
that confidential supporting information for the 
purposes of determining whether to grant any 
application other than the application to which it 
relates or related, as the case lllay be,-
"(i) With the consent of the applicant who made 
the application to which the confidential supporting 
information relates or related; or 
"(ii) If that disclosure or use is, in the opinion of 
the Board, necessary to protect the health or safety 
of members of the public; or 
"(b) Disclose that confidential supporting information to­
"(i) A Government department or statutory body 
for the purposes of that Government departlllent or 
statutory body: 
"(ii) An adviser for the purposes of obtaining 
advice about the pesticide to which the information 
relates,-
if, in the opinion of the Board, the Government 1994, No. 127 Pesticides Amendment JP IN 11 INZL/U 11 
Page 11 
5 
department, statutory body, or adviser, as the case 
Illay be, will take reasonable steps to ensure that 
information is kept confidential; or 
"(c) Disclose that confidential supporting information to­
"(i) The World Health Organisation: 
"(ii) The Food and Agriculture Organisation: 
"(iii) A regulatory agency of a WTO country: 
"(iv) A person or organisation, or a person or 
organisation within a class or classes of persons or 
organisations, approved by regulations made under 
this Act. 
"(2) The power to grant consent under subsection (1) (a) (i) of 
this section Illay be exercised by a person other than the 
aPElicant referred to in that subsection if-
'(a) That a:eplicant-
'(i) Has notified the Board in writing that that 
other person may grant that consent; and 
"(ii) Has not notified the Board in writing that that 
person's authority to grant that consent has been 
withdrawn:; or 
"(b) That applicant's rights in respect of the relevant 
confidential supporting information have been 
transferred to that person and the applicant or that 
person has notified the Board in writing of the 
transfer. 
"35n. Protection· of infonnation about agricultural 
chetnicals-Where the Board has inforrnation-
"(a) That related to an application to register a substance as 
an agricultural chemical under section 14 of the 
Agricultural Chemicals Act 1959; and 
"(b) That would have been confidential supporting 
inforIllation in respect of which the Board would 
have had obligations under section 35B of this Act 
had it been given in relation to an application,-
this Part of this Act shall apply, with such Illodifications as mar, 
be necessary, as if it were confidential supporting information. ' 
8. Regulations-Section 76 of the principal Act is hereby 
amended by inserting, after paragraph (d), the following 
paragraph: 
"(da) Approving persons or organisations, or classes of 
persons or organisations, for the purposes of section 
35c (1 ) (c) (iv) of this Act:". 
This Act is administered in the Ministry of Agriculture and Fisheries. 
WELLINGTON, NEW ZEALAND: Published under the authority of the 
New Zealand Government-1994 
59517H-94/NS IP/N/1/NZL/U/1 
Page 12 
1994 M edicines Amendment No. 128 
ANALYSIS 
23B. Protection of confidential sup· 
porting infonnation about 
innovative medicines 
Title 23c. Circumstances where protec· 
tion under section 23B does 
not apply 1. Short Title and commencement 
2. New sections inserted 
23A. Interpretation 3. Regulations 
1994, No. 128 
An Act to alllend the Medicines Act 1981 
[9 December 1 994 
BE IT ENACTED by the Parliament of New Zealand as follows: 
1. Short Title and cOllllllencelllent-( 1) This Act may be 
cited as the Medicines Amendment Act 1 994, and shall be read 
together with and deemed part of the Medicines Act 1981 
(hereinafter referred to as the principal Act). 
(2) This Act shall come into force on a date to be appointed 
by the Governor-General by Order in Council; and one or more 
orders may be made bringing different provisions into force on 
different dates. 
2. New sections inserted-The principal Act is hereby 
amended by inserting, after section 23, the following sections: 
"23A. Interpretation-In this section, and in sections 23B 
and 23c of this Act, unless the context otherwise requires,­
" 'Applicant' means-
"(a) A person who makes or has made, as the case 
may be, an application; and 
"(b) A person on whose behalf an application is, or 
has been, made, as the case may be: . 
" 'Application' means an application for the consent of the 
Minister under section 20 of this Act, or for the 
provisional consent of the Minister under section 23 
of this Act, in relation to a medicine: 
Public-128 Price Code: 5-BY 2 M edicines Amendment IP/N/1/NZL/U/1 
Page 13 
1994, No. 128 
" 'Commencement date' means the date this section, and 
sections 23B, and 23c of this Act come into force: 
" 'Confidential information' includes-
"(a) Trade secrets; and 
"(b) Information that has commercial value that 
would be, or would be likely to be, diminished by 
disclosure: 
" 'Confidential supporting information' means confidential 
information given-
"(a) In, or in relation to, an innovative medicine 
application; and 
"(b) About the medicine that is or was, as the case 
may be, the subject of that application: 
" 'Ingredient' includes a chemical or biological entity: 
" 'Innovative Illedicine application' means,-
"(a) In relation to an application Illade after the 
COIllmencement date, an application that refers to an 
active ingredient-
"(i) That is an active ingredient of the Illedicine 
to which the application relates; and 
"(ii) That has not, before that application is 
received by the Minister, been referred to 
in any other application (except in an 
application by the applicant for provisional 
consent for that Illedicine) as an active 
ingredient of a Illedicine; and 
"(b) In relation to an application Illade before the 
commenceIllent date, an application that referred to 
an active ingredient-
"(i) That is or was, as the case Illay be, an active 
ingredient of the medicine to which the 
application related; and 
"(ii) That had not, before that application was 
received by the Minister, been referred to 
in any other application (except in an 
application by the applicant for provisional 
consent for that Illedicine) as an active 
ingredient of a Illedicine: 
" 'Protected period' means-
"(a) In relation to confidential supporting 
information, relating to an innovative medicine 
application, received by the Minister after the 
COIllmenceIllent date, a period cOIllIllencing on the 
date that information is received by the Minister and 
ending,-IP/N/1/NZL/U/1 
Page 14 
1994, No. 128 Medicines Amendment 3 
"(i) Where-
"(A) The Minister has either notified 
consent, not being provisional consent, in 
the Gazette under section 20 of this Act, or 
refused to grant such consent, in relation 
to the medicine that is the subject of the 
innovative medicine application; and 
"(B) The date of that notification or 
refusal is not more than 5 years after the 
Minister received an application in relation 
to that medicine,-
on the date 5 years after the date of that 
notification or refusal; or 
"(ii) In any other case, on the date 5 years after 
the innovative medicine application to 
which that information relates is or was, as 
the case may be, received by the Minister: 
"(b) In relation to confidential supporting 
information, relating to an innovative medicine 
application, received by the Minister not more than 
5 years before the cornmencernent date, a period 
cornrnencing on the commencement date and 
ending,-
"(i) Where-
"(A) The Minister has notified or notifies 
consent, not being provisional consent, in 
the Gazette under section 20 of this Act, or 
refused or refuses to grant such consent, in 
relation to the medicine that was the 
subject of the innovative medicine 
application; and 
"(B) The date of that notification or 
refusal is or was, as the case rnay be, not 
more than 5 years after the Minister 
received an application in relation to that 
medicine,-
on the date 5 years after the date of that 
notification or refusal; or 
"(ii) In any other case, on the date 5 years after 
the innovative medicine application to 
which that information related was 
received by the Minister: 
" 'WTO Country' means a country that is a party to the 
Agreement establishing the World Trade 4 M edicines Amendment IP/N/I INZL/UI 1 
Page 15 
1994, No. 128 
Organization adopted at Marrakesh on the 15th day 
of April 1994. 
"23B. Protection of confidential supporting 
infonnation about innovative tnedicines-Where the 
Minister receives, or received not more than 5 years before the 
commencement date, an innovative medicine application and 
confidential supporting information, the Minister, during the 
protected period in relation to that confidential supporting 
information, -
"(a) Shall take reasonable steps to ensure that that 
confidential supporting information IS kept 
confidential to the Minister; and 
"(b) Shall not use that confidential supporting information 
for the purposes of determining whether to grant 
any other application. 
"23c. Circutnstances where protection under 
section 23B does not apply-(l) Notwithstanding section 23B 
of this Act, the Minister may, during the protected period in 
relation to confidential supporting information,-
"(a) Disclose that confidential supporting information, or use 
that confidential supporting information for the 
purposes of determining whether to grant any 
application other than the application to which it 
relates or related, as the case may be,-
"(i) With the consent of the applicant who made 
the application to which the confidential supporting 
information relates or related; or 
"(ii) If that disclosure or use is, in the opinion of 
the Minister, necessary to protect the health or 
safety of members of the public; or 
"(b) If, in the opmlon of the Minister, the relevant 
committee, adviser, GoveITlment department, 
statutory body, or person will take reasonable steps to 
ensure the confidential supporting information is kept 
confidential, disclose that confidential supporting 
information to-
"(i) An advisory or technical committee appointed 
under section 8 of this Act; or 
"(ii) The Medicines Classifications Committee 
appointed under section 9 of this Act; or 
"(iii) The Medicines Review Committee established 
under section 1 0 of this Act; or IP/N/1/NZL/U/1 
Page 16 
1994, No. 128 Medicines Amendment 5 
"(iv) Any adviser for the purpose of obtaining 
advice about the medicine to which the confidential 
supporting information relates; or 
'''(v) A Government department or statutory body 
for the purposes of the Government department or 
statutory body; or 
"(c) Disclose that confidential supporting information to any 
one or more of the following-
"(i) The World Health Organisation: 
"(ii) The Food and Agriculture Organisation: 
"(iii) Any regulatory agency of a WTO Country: 
"(iv) Any person or organisation, or a person or 
organisation within a class or classes of persons or 
organisations, approved by regulations made under 
this Act. 
"(2) The power to grant consent under subsection (1) (a) (i) of 
this section may be exercised by a person other than the 
aPBlicant referred to in that subsection if-
'(a) That applicant-
"(i) Has notified the Minister in writing that that 
other person may grant that consent; and 
"(ii) Has not notified the Minister in writing that 
that person's authority to grant that consent has been 
withdrawn; or 
"(b) That applicant's rights in respect of the relevant 
confidential supporting information have been 
transferred to that person and the applicant or that 
other person has notified the Minister in writing of 
the transfer." 
3. Regulations-Section 1 05 of the principal Act is hereby 
amended by inserting, after paragraph (a), the following 
paragraph: 
"(aa) Approving persons or organisations, or classes of 
persons or organisations, for the purposes of section 
23c (1) (c) (iv) of this Act:". 
This Act is administered in the Ministry of Health. 
WELLINGTON, NEW ZEALAND: Published under the authority of the 
New Zealand Government-1994 
59518C-94 INS 