Conditions of registration

Every veterinary medicine, agricultural chemical, or vertebrate toxic agent included in this register will have specific conditions from this list.
Retired conditions are not included in this list.
Condition 2:

The product must be manufactured in accordance with the Ministry for Primary Industries Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications provided by the registrant and approved as part of the registration.

Condition 3:

Plant Compound: In addition to any labelling, advertising or promotion requirements specified in the current registration, labelling, advertising or promotion of the product must comply with the current Ministry for Primary Industries - New Zealand Labelling and Advertising Guide for Plant Compounds Requiring Registration.

Condition 4:

The product must only be sold or imported according to the current registration.

Condition 5:

The product may be sold or used by any person.

Condition 6:

The product must not be used on any plant or in any manner specifically prohibited in the current registration.

Condition 8:

If the product is used on any food producing plant or on or around any plant not used to produce food:
· other than those specified on the current registration; or
· in a manner not specified in the current registration,
the user must ensure that residues of any substance in the product that may occur in plant material produced from the plants treated, or in animal material produced from grazing or direct feeding of the plants treated to food producing animals, do not exceed the lesser of either:
· the specified residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments; or
· the default maximum residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments, when a maximum residue limit for that substance has not been specified.

Condition 11:

Veterinary Medicine: In addition to any labelling, advertising or promotion requirements specified in the current registration, labelling, advertising or promotion of the product must comply with the current Ministry for Primary Industries - New Zealand Labelling and Advertising Guide for Veterinary Medicines Requiring Registration.

Condition 14:

Class II Prescription Animal Remedy
The product must be sold only by an approved trader.

The product must be sold only to an approved trader, or to any person with a veterinary prescription or authorisation.

The product must be administered to an animal only by, in the presence of or under the control of a veterinarian, unless specified otherwise in the current approval.

Condition 16:

Over-the-counter Veterinary Medicine
The product may be sold or used by any person without a veterinary prescription.

The product must not be used by any person on animals or in a manner specifically prohibited in the current registration.

Use of the product by any person other than a veterinarian in any other animal or in any other manner other than those specified in the current registration must be done only after seeking veterinary advice.

Condition 17:

The product formulation and quantity must comply with and is limited to that specified in the application and Product Specific Approval.

Condition 18:

The trial conditions, including the Study Director and trial sites must comply with the measures approved by the Ministry for Primary Industries as specified in the application and Product Specific Approval.

Condition 19:

The conditions attached to the product must be given in writing and followed by any person involved in any aspect of the activities covered in the application.

Condition 20:

The product must only be used on the plants or animals specified and in the manner specified in the application and Product Specific Approval.

Condition 21:

Treated crops, animals, produce or commodities must be destroyed and must not enter the food chain, unless specifically provided for in the Product Specific Approval.

Condition 22:

The product must not be advertised or sold.

Condition 23:

Security of this product must comply with the measures approved by the Ministry for Primary Industries as specified in the application.

Condition 25:

The location of any trial sites not identified in the site and systems in the application must be notified to the Ministry for Primary Industries as soon as they are known.

Condition 27:

This product must only be sold to and used by the individuals/organisations specified in the label content.

Condition 31:

This product must only be used as specified in the label content.

Condition 34:

An annual report of sales by month must be supplied by the registrant to the Ministry for Primary Industries.

Condition 36:

This product must only be imported by the registrant or the New Zealand agent specified in the current approval.

Condition 37:

Ongoing obligations:
The registrant must provide an annual summary of adverse events to the Ministry for Primary Industries. Adverse events which have serious implications for the continued use of the product must be notified immediately.
The registrant must also advise the Ministry for Primary Industries of any new studies or data that contradict information previously supplied.

Condition 38:

Every person must comply with the requirements specified in the Product Specific Approval part of the current registration.

Condition 40:

The registrant must ensure this product is fit for purpose as an oral nutritional compound as required under Schedule 4 of the Agricultural Compounds and Veterinary Medicines Regulations 2001.

Condition 41:

No change in formulation can be made that results in the inclusion of additional non-GRAS ingredients or increase in the quantity or feeding rate of the currently approved non-GRAS ingredients without prior approval by the Ministry for Primary Industries.

Condition 42:

Tuberculin Specific Condition
The product must be sold only by an approved trader.
The product must be sold only to an approved trader, or to any person with a veterinary prescription or authorisation, or to persons approved under Section 103 of the Biosecurity Act 1993.
The product must be administered to an animal only by a veterinarian,
or under and in accordance with the authority or prescription of a veterinarian,
or by persons approved under Section 103 of the Biosecurity Act 1993 when applying cattle and deer tuberculin tests.

Condition 43:

The product must be sold only by a person who has been approved by the Ministry for Primary Industries.

Condition 44:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

This product must be sold only to a person holding a controlled substances licence issued by a test certifier who has been approved by the Ministry for Primary Industries.

Condition 45:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

Any advertisement or promotion for this product must clearly state that it can only be sold to a person who holds a controlled substances licence.

Condition 46:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

The product must not be displayed for the general public to see. It must be kept secure from unauthorised persons and individual containers marked for trace back purposes. A register of sales must be kept (minimum of 3 years), recording who the product was sold to (controlled substances licence reference) and the container(s) serial identity.

Condition 47:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

The product must be used only by a person either holding a controlled substances licence issued by a test certifier who has been approved by the Ministry for Primary Industries, or by a person under the direct supervision of a person holding a controlled substances licence.

Condition 48:

If the product is to be aerially applied, then the public must be given sufficient notice prior to application informing them of:
a) what is being used;
b) when it is to be used;
c) where it is going to be used;
d) the responsible person; and
e) appropriate warnings in regard potential harm (dogs should be kept out of the area).
The application must not be earlier than the date of application stated in the public notification and, if the product has not been applied within 2 months, the notification is invalid.

Condition 49:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

Signs must be posted in prominent places around the perimeter of the treated area. The signs must remain in place until monitoring confirms that the product is no longer present. Signs must state:
a) that it is an offence for any person to remove the sign(s) prior to clearance of the area;
b) that it is an offence for any person (other than the applicator) to remove/move baits from the area;
c) Warning of potential harm to dogs.

Condition 50:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:

Security, identity and application of the product must be under the control of a specified person who also holds a controlled substances licence from a test certifier approved by the Ministry for Primary Industries.

Condition 51:

Vertebrate Toxic Agents: In addition to any labelling, advertising or promotion requirements specified in the current registration, labelling, advertising or promotion of the product must comply with the current Ministry for Primary Industries - New Zealand Labelling and Advertising Guide for Vertebrate Toxic Agents Requiring Registration.

Condition 52:

Any person (other than a person authorised by the Department of Conservation) must only use this product in accordance with the Operating Plan entitled Aerial and Hand Broadcast Application of Pestoff® Rodent Bait 20R for the intended Eradication of Rodents from Specific Areas of New Zealand (approved by the Director-General of the Ministry for Primary Industries).

A person authorised by the Department of Conservation must only use this product a) on offshore islands that do not have livestock present at any time or b) in accordance with the Operating Plan referred to above

Condition 53:

A register of sales must be kept (minimum of 3 years), recording who the product was sold to and the quantity sold.

Condition 54:

Signage must remain in place for a minimum of 9 months after baiting has ceased.

Condition 55:

For pack sizes greater than 3kg, the product must be sold only by a person who has been approved by the Ministry for Primary Industries.

Condition 56:

For pack sizes greater than 3kg, a register of sales must be kept (minimum of 3 years), recording who the product was sold to and the quantity sold.

Condition 57:

If the product is applied where public may have access to the treatment area, signs must be posted in prominent places around the perimeter of the treated area. The signs must remain in place until monitoring confirms that the product is no longer present. Signs must state:
a) that it is an offence for any person to remove the sign(s) prior to clearance of the area;
b) that it is an offence for any person (other than the applicator) to remove/move baits from the area;
c) a warning of potential harm to dogs
d) a warning that feral animals may contain residues of the toxin and should not be taken for food.

Condition 58:

Advertising and promotion must only be directed to registered veterinarians or persons with an ACVM approval to trade in this product.

Condition 60:

The manufacture of the product must, at all times, conform to the product and manufacturing specifications approved as part of this registration.

Condition 61:

The product must be labelled in accordance with the product and manufacturing specifications approved as part of this registration.

Condition 62:

The product must be manufactured by a person specified to manufacture it and acting in accordance with an operating plan approved under section 28.

Condition 63:

Persons responsible for the product at each stage throughout its distribution must maintain the product in a manner that ensures it conforms to the approved product and manufacturing specifications through to the product's retail sale.

Condition 64:

The registrant must investigate the significance of every adverse event associated with the use of the product; and report to Ministry for Primary Industries within 20 working days the outcome of this investigation.

The registrant must notify Ministry for Primary Industries immediately upon becoming aware of an adverse event that seems to have seriously jeopardised the health and welfare of the treated/exposed animal(s); and may require the use of the product to be stopped or restricted to prevent similar adverse events.

Condition 65:

The registrant must, as soon as practicable after becoming aware of new information, advise Ministry for Primary Industries of any new information that relates to the relevance, reliability or correctness of information provided at the time of registration and upon which the decision to register the product was made.

Condition 66:

No advertisement for the product may:

(a) include content or be presented in a manner that does not conform to the approved product and manufacturing specifications (this includes approved uses);

(b) contain false or misleading claims, statements or information in relation to the product; or

(c) without limitation to the generality of (b), directly or by implication make false or misleading claims or statements about the regulatory status of the product under the ACVM Act.

Condition 67:

Any person using the product on any animal from which animal material as defined in the Animal Products Act 1999 is likely to be used for human consumption (whether that use is in accordance with the approved product label or not) must ensure that residues of any substance in the product that may occur in animal material produced from the treated animals, do not exceed the lower of either:

(a) the specified residue level in the current Food Notice: Maximum Residue Levels of Agricultural Compounds; or

(b) where a maximum residue level for that substance has not been specified, the default maximum residue level in the current Food Notice: Maximum Residue Levels of Agricultural Compounds.

Condition 68:

Any person using the product on any animal or in any manner other than as specified in the approved product and manufacturing specifications must, before using the product, seek advice from an appropriately qualified source and confirm that the intended use is not likely to cause unnecessary or unreasonable pain or distress in the animal treated.

Condition 69:

The product must be sold only by either:
(a) A veterinarian recognised under section 44G to authorise its purchase and use for animals under that veterinarian’s care; or
(b) A person specified to sell the product or similar products in and acting in accordance with a relevant operating plan approved under section 28.

Condition 70:

For the purposes of the condition, ‘veterinary authorisation’ means that a veterinarian recognised under section 44G has issued a valid authorisation for its purchase and use.

Any advertisement of this product must contain a statement that the product is available for purchase and use only under and in compliance with a veterinary authorisation.

Condition 71:

The product must be sold only to:
a) A person specified in an approved operating plan; or
b) Any person in possession of a valid authorisation issued either,
(i) by a veterinarian recognised under section 44G to issue an authorisation for its purchase and use, or
(ii) under and in accordance with an approved operating plan.

Condition 72:

The product must be used under the authority of and in accordance with a valid authorisation issued either:
(a) by a veterinarian recognised under section 44G to issue a valid authorisation for its purchase and use; or
(b) under and in accordance with an approved operating plan.

Condition 73:

All veterinarians recognised under section 44G to issue an authorisation to purchase and use a restricted veterinary medicine must comply with ‘ACVM Notice Requirements for Authorising Veterinarians’ issued by the Director General, and for the time being in place, under section 44ZN of the Act, for authorising this type of product.

Condition 82:

For the purposes of this condition, an adverse event is any event that brings into question the relevance or reliability of information provided at the time of registration and upon which the decision to register the product was made.

The registrant must notify Ministry for Primary Industries of an adverse event in relation to the product, immediately upon becoming aware of the event, where the event has or may have significant implications for the continued use of the product.

Condition 83:

Any person using the product must ensure that residues of any substance in the product that may occur in:

(a) Plant material intended for human consumption produced from plants or plant material treated with the product, or

(b) Animal material as defined in the Animal Products Act 1999 intended for human consumption produced from grazing or direct feeding plants or plant material treated with the product to food producing animals does not exceed the lower of either:
(i) the specified residue level in the current Food Notice: Maximum Residue Levels for Agricultural Compounds; or
(ii) the default maximum residue level in the current Food Notice: Maximum Residue Levels for Agricultural Compounds, when a maximum residue level for that substance has not been specified"

Condition 84:

The product must not be used on animals unless the use is approved as part of this registration.

Condition 86:

The registrant must provide a batch analysis, which confirms that the product meets the approved release specifications, from the first production batch at the new manufacturing site to Ministry for Primary Industries for approval prior to sale of product from this new site.

Condition 87:

This product must only be used according to the label except where permission for an off-label use has been granted by the Ministry for Primary Industries. Where permission has been granted, use of the product must comply with any additional controls stated in the documentation confirming permission.

Condition 88:

Random samples must be taken from each batch/lot imported into the country and tested for compliance with the provided Certificate of Analysis. This sampling must occur before the product is released for sale. This testing must be performed in a GMP or ISO 17025 accredited laboratory according to pharmacopeia or test methods quoted on the Certificate of Analysis. Completed assay results must be retained for Ministry for Primary Industries audit purposes.

Material must be inspected on arrival to ensure it is labelled correctly and has traceability back to the Certificates of Analysis received.

Condition 89:

The product must be imported, distributed, sold or used only in accordance with the relevant operating plan approved under section 28.

Condition 90:

This product must not be used on any animal producing, or intended to produce food for human consumption.

Condition 96:

If the product is applied where public may have access to the treatment area, signs must be posted in prominent places around the perimeter of the treated area. The signs must remain in place until monitoring confirms that the product is no longer present. Signs must state:
a) that it is an offence for any person to remove the sign(s) prior to clearance of the area;
b) that it is an offence for any person (other than the applicator) to remove/move baits from the area;
c) a warning of potential harm to dogs and the appropriate antidote.

Condition 97:

This product must only be used in the species identified on the label.

Condition 98:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:
This product must be sold only to a person holding a controlled substances licence.

Condition 99:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:
The product must be used only either by a person holding a controlled substances licence or by a person under the direct supervision of a person holding a controlled substances licence.

Condition 100:

If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then:
Security, identity and application of the product must be under the control of a specified person who also holds a controlled substances licence.

Condition 101:

The registrant must provide additional information specified by the Ministry for Primary Industries at or before the expiry of the current product registration period.

Condition 102:

The product must be sold only by an approved trader.

The product must be sold only to an approved trader.

The product must be administered to an animal only by a registered veterinarian holding a current practising certificate issued under the Veterinarians Act 2005 or under the direct supervision of a veterinarian.

Any advertisement of this product must contain a statement that the product is available for purchase and use only by a veterinarian.

Condition 106:

This product must only be used as specified in the label content or in accordance with an operating plan approved under Section 28 of the Agricultural Compounds and Veterinary Medicines Act 1997.

Condition 108:

The registrant must provide sufficient consumer advice about the on-going stability of the product for use if requested by any purchaser of the product.

The registrant must withdraw the product from the market place where evidence shows it is no longer capable of meeting its expiry specifications prior to its use, when stored in line with the manufacturers recommendations.

Condition 109:

The registrant must provide to MPI every quarter, a summary of all adverse events made known to them during the registration period.

Condition 111:

The product must only be applied at sites registered with Kiwifruit Vine Health for use in an approved region.

Condition 112:

A site inspection must be conducted by the person responsible for the management of the orchard prior to application. The inspection must confirm that:
1. no livestock access is possible,
2. no non-target crops are within the spray block (or outside of the block if drift cannot be managed).
3. vines to be treated will not be in flower
4. no other flowers will be present in the orchard at time of application .
5. spray drift can be appropriately managed.
6. the intended site matches that registered with KVH

Condition 113:

The person applying the product must have a current Growsafe certificate and suitable experience in relation to the use of agricultural chemicals.

Condition 114:

Neighbours and beekeepers with hives on the property being treated or neighbouring properties must be notified at least 12 hours (but preferably 48 hours) prior to application.

Condition 115:

The registrant on becoming aware of any significant breach of the controls is required to notify the Ministry for Primary Industries as soon as practicable.

Condition 116:

The person responsible for the orchard is required to maintain records of use detailing the following information:
(a) the name of the product
(b) the batch number for the product to be applied and place of purchase
(c) the date and time of each application
(d) the amount of the product applied and the associated water rates
(e) the location where the product was applied
(f) a description of the application equipment
(g) the name of the user of the product and the user's address
(h) details of the spray drift mitigation measures
(i) details of any non-conformance with the controls imposed on use of the product

The record of use must be kept for not less than 4 years after the date on which the substance that the record relates to is applied.

Condition 117:

A person applying the product must take all practicable steps to prevent spray drift outside of the area intended for treatment.

Condition 118:

The registrant is responsible for ensuring that sufficient records are kept throughout the distribution chain to ensure that product can be traced.

Condition 119:

The product must not be sold unless identification has been provided by the purchaser and the following information recorded:
1. The amount of product sold.
2. The full name and contact details for the person purchasing the product.
3. The intended use.

Condition 120:

If the product is applied where public may have access to the treatment area, signs must be posted in prominent places around the perimeter of the treated area. The signs must remain in place for at least 2 months after retrieval and 4 months after the last application. Signs must state:
a) that it is an offence for any person to remove the sign(s) prior to clearance of the area;
b) that it is an offence for any person (other than the applicator) to remove/move baits from the area;
c) a warning of potential harm to dogs and the appropriate antidote.

Condition 121:

The person responsible for the orchard or nursery the product is being used in is required to maintain records of use detailing the following information: (a) the name of the product (b) the batch number for the product to be applied and place of purchase (c) the date and time of each application (d) the amount of the product applied and the associated water rates (e) the location where the product was applied (f) a description of the application equipment (g) the name of the user of the product and the user's address (h) details of the spray drift mitigation measures (i) details of any non-conformance with the controls imposed on use of the product. All non-conformances must be notified to the registrant.

Condition 123:

Any beehives in the area to be treated must be covered to prevent exposure to product during application or removed from the area. Hives can only be reintroduced or uncovered once spray deposits have dried.

Condition 124:

To reduce the risk of residues in bee products, measures must be taken to ensure that flowers on non-target plants that may be foraged by bees are kept to the absolute minimum practically possible in the area being treated (e.g. by mowing or use of a suitable herbicide before treatment). If significant numbers of flowers are present on non-target plants present in the orchard being treated, this product must not be used.

Condition 125:

When the product is to be used on kiwifruit the following requirements must be met: 1. The site where the product is to be used must be within a Kiwifruit Vine Health approved region. 2. A site inspection must be conducted by the person responsible for the management of the orchard prior to application. The inspection must confirm that: - no livestock access is possible - no non-target crops are within the spray block - vines present at the site to be treated will not be in flower at the time of application. - spray drift can be appropriately managed at the site - condition 123 (prevention of hive exposure) and condition 124 (minimisation of non-target flowers) will be complied with. 3. A record of the site inspection must be kept confirming the above points have been addressed. The record must be retained for a period of four years.

Condition 126:

The following requirements will apply to use on pipfruit, stonefruit and seedling tomatoes from July 2014. 1. A site inspection must be conducted by the person responsible for the management of the site of application prior to use of the product. The inspection must confirm that: - no livestock access is possible - no non-target crops are within the area being sprayed - spray drift can be appropriately managed at the site - timing of application will be consistent with the label - condition 123 (prevention of hive exposure) and condition 124 (minimisation of non-target flowers) will be complied with. 2. A record of the site inspection must be retained confirming the above points have been addressed. The record must be retained for a period of four years.

Condition 127:

The registrant or any other party selling the product must provide a copy of the conditions of registration applicable to the user to each person purchasing the product.

Condition 129:

The product must not be used for growth promotion in ruminants intended for human consumption.

Condition 130:

Persons responsible for the product at each stage throughout its distribution must maintain the product in a manner that ensures it conforms to the approved product and manufacturing specifications through to the time of use.

Condition 132:

This product must only be used as specified in the label content. This condition comes into force on 1 July 2016.

Condition 135:

The product must only be packaged in new HDPE containers or 200lt steel drums of food or pharmaceutical grade.

Condition 137:

This product must not be used on any crop that is not specified in the Directions for Use on the label.