This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register an anticoccidial in
poultry, or to vary the conditions on a registered anticoccidial in poultry. It also
incorporates guidelines, which are intended to provide more detailed information and
guidance to applicants to assist them in complying with the standard.
Guidance resources
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This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register an antihistamine
product, or to vary the conditions on a registered antihistamine product. It also
incorporates guidelines, which are intended to provide more detailed information and
guidance to applicants to assist them in complying with the standard.
This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register an antispasmodic
product, or to vary the conditions on a registered antispasmodic product. It also
incorporates guidelines, which are intended to provide more detailed information and
guidance to applicants to assist them in complying with the standard.
This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register a corticosteroid or
to vary the conditions on a registered corticosteroid. It also incorporates guidelines,
which are intended to provide more detailed information and guidance to applicants to
assist them in complying with the standard.
This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register an emetic, or to
vary the conditions on a registered emetic. It also incorporates guidelines, which are
intended to provide more detailed information and guidance to applicants to assist them
in complying with the standard.
Efficacy of a veterinary medicine is understood to be the degree to which the medicinal
claims made by the applicant have been justified and are likely to be attained under
practical field conditions within New Zealand. The need for an efficacy standard arises
from section 4 of the Agricultural Compounds and Veterinay Medicines (ACVM) Act
1997, which provides for prevention or management of risks associated with the use of
agricultural compounds:
• risks to trade in primary produce; and
• risks to animal welfare; and
• risks to agricultural security.
This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register a vaccine, or to
vary the conditions on a registered vaccine. It also incorporates guidelines, which are
intended to provide more detailed information and guidance to applicants to assist them
in complying with the standard.
This document specifies the minimum study and reporting requirements, i.e. the standard,
for efficacy studies submitted in support of an application to register a zinc prophylactic
product for facial eczema, or to vary the conditions on a registered zinc prophylactic
product for facial eczema. It also incorporates guidelines, which are intended to provide
more detailed information and guidance to applicants to assist them in complying with
the standard.
While some pain or distress to the animal is inevitable at times from administration of
a product, the intensity and duration must be no more than is necessary to prevent or
treat the condition concerned. Some recognition is therefore required of the extent of
suffering that may arise from the use of alternative products and the suffering that may
arise from not administering the product.
The adverse event reporting programme is part of the quality assurance programme developed by the Ministry for Primary Industries (MPI). It aims to ensure that all agricultural chemicals in the marketplace are efficacious, of acceptable quality, used appropriately, and that product labels provide sufficient consumer information for correct use.
Explains the Adverse Event Reporting Programme and actions to take if an adverse event with an agricultural chemical occurs.
This is a quality assurance programme developed by the Ministry for Primary Industries (MPI). It aims to ensure that all veterinary medicines in the marketplace are safe, efficacious, of acceptable quality, used appropriately, and that product labels provide sufficient consumer information for correct use.