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General advice on products

Since the commencement of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 and the Hazardous Substances and New Organisms (HSNO) Act 1996, the ACVM Group has received a number of enquiries in regard to a wide range of registration issues.

Responding to those enquiries has been difficult because of ongoing discussions with the Environmental Risk Management Authority (ERMA NZ) about the interface between the two Acts. At this stage the following is the most definitive basic advice that can be given from an ACVM perspective.

Aspects of the advice will not be appropriate in all cases because of the range of products, the variable risks they pose and the variations in the requests being made. To be certain of advice, contact the customer services officers of the ACVM Group. Any enquiries about the relevance of the HSNO Act in a particular case should be directed to ERMA NZ.

MINOR variations to existing licences and registrations

Variations to existing licences and registrations can be made, but the application must be lodged by the licensee or registrant. The variation must not materially change the specifications of the product or the risks posed by the product. If a variation is processed under the transitional provisions of the ACVM Act, the outcome will still be an animal remedy licence or pesticide registration that will have to be converted to an ACVM registration before the end of the transition period (2 July 2004). Hazardous substance approvals from ERMA NZ are irrelevant for variations to existing licences or registrations that remain as animal remedy licences or pesticide registrations.

MAJOR variations to existing licences or registrations

If the change to the licence or registration significantly alters the specifications of the product or the risks it poses, a new registration may be required. The application must be processed in accordance with the ACVM Act and the outcome will be a new ACVM registration.

If a new registration is required, the ACVM Group must have confirmation from the applicant that the product is not a hazardous substance. This can be confirmed via a declaration from the applicant to that effect.

If the hazardous substance status of  the product is uncertain, the ACVM Group will be able to process the application from its perspective, but it will not be able to issue the new registration until the applicant confirms that it is not hazardous or that the appropriate ERMA NZ approvals have been issued.

New registrations

Applications for new registrations must be processed under the ACVM Act. This includes applications for registration of products that are mirror images of licensed or registered products where the applicant is not the licensee or registrant.

To issue a registration the ACVM Group must have confirmation from the applicant that the product is not a hazardous substance. As above, this can be done via a declaration from the applicant.

If the hazardous substance status of the product is uncertain, the ACVM Group will be able to process the application from its perspective but it will not be able to issue the new registration until the applicant confirms that it is not hazardous or that the appropriate ERMA NZ approvals have been issued.

Transfer of existing licences and registrations to ACVM registrations

At this stage existing licences and registrations can be transferred to ACVM registrations if the product is exactly the same as the one that is licensed or registered. The ACVM Group is aware that for some products there has been, over time, a drift in the product specifications so that the product currently being marketed is not quite the same as the one that is licensed or registered.

The ACVM Group has previously advised that, if the drift is not significant from a product identity and risk management perspective, then the product data sheet provided by the licensee or registrant will be used as the definitive description of the product that is being transferred. However, if the drift has been significant, then a new registration may be necessary. It is recommended that you contact the ACVM Group if you suspect any discrepancy.

Licences or registrations will be transferred by two mechanisms: [ continued>> ]