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AgVetLink: Number 54, February 2006

Agreement with Biosecurity NZ

The Approvals and ACVM Group has signed an operational agreement with Biosecurity New Zealand (BNZ) for compliance and enforcement activities regarding release of new organisms that are, or are contained in, veterinary medicines. This agreement clarifies the roles of the two agencies in confirming that the controls imposed under the Hazardous Substances and New Organisms (HSNO) Act 1996 on the approval of a new organism are complied with when that organism is being used as a veterinary medicine. For example, a new organism may be contained in an animal vaccine that is registered with conditions under the ACVM Act. These conditions are in addition to the controls imposed under the HSNO Act.

The Biosecurity Authority is the primary compliance body in this area and the one charged with investigating suspicions or allegations of non-compliance and, subsequently, taking enforcement action.

The Group has agreed that, when NZFSA carries out its investigations for compliance with ACVM conditions on the registration of a veterinary medicine containing a new organism, it will also investigate compliance with the HSNO controls at the same time, reporting any non-compliance to BNZ. The Group will maintain a list of registered veterinary medicines that are or contain new organisms. This list will form the basis for the cooperative activity.

At this stage there are no registered veterinary medicine products that are or contain new organisms.