New Zealand - English - Ministry for Primary Industries
Ref No A011700-01
Public Record of Delegate Decision
For granting an application for registration under section 21 of the Agricultural Compounds and Veterinary
Medicines Act 1997
Famers Industries (NZ) Limited
Date of Delegate
27 October 2020
This registration will expire 2 years from the date of this Delegate’s Decision.
Protected CI - New Registration - Innovative Trade Name Product
Summary of reasons for the Decision to grant the Application
Chemistry/Manufacturing: Chemistry and manufacturing information conformed to MPI requirements and was
sufficient to confirm the identity and quality of the product.
The product data sheet is complete, accurate and current.
The manufacturer has the appropriate approval. Manufacturing specifications conformed to MPI requirements and
were sufficient to show that the product could be consistently manufactured to those specifications.
Stability trials and data conformed to MPI requirements and were sufficient to assess.
Efficacy: Efficacy trials and data conformed to MPI requirements and were sufficient to assess.
Safety: Safety trials and data conformed to MPI requirements and were sufficient to assess.
Residues: Residue trials and data conformed to MPI requirements and were sufficient to assess.
Trade: The product has been assessed in regard to the impact its use may have on trade in primary produce.
Public health: Due to the nature of the product and how it is intended to be used there were no additional public
health matters that needed to be addressed over and above those covered under the Hazardous Substances and
New Organisms Act 1996.
Recommendation to Register
On the basis
of the above information, the product as approved, and when imported, manufactured, sold or used
in accordance with the conditions listed below, is not likely to cause unacceptable risks to:
trade in primary produce
animal welfare or
Ref No A011700-01
In balance, there are sufficient benefits to warrant this product to be registered.
When used in accordance with this approval, the product is not likely to cause residues in primary produce, food
or food-related products that would breach domestic food residue standards.
The assessed label content is adequate to provide sufficient consumer information to allow the product to be used
appropriately and safely and meets labelling requirements.
Being satisfied of the matters above, and under delegated authority pursuant to the Agricultural Compounds and
Veterinary Medicines Act 1997, this application for registration is granted, under section 21(1)(d) under the
conditions as listed on the Register.