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AgVetLink July 2003 - Special Issue for Registrants

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Draft operational policy for PAR products – impact on registrants

The ACVM Group is required to identify the risks and benefits for each application, and apply conditions to manage the risks in a cost effective manner. In an effort to be consistent and transparent, we have written down the ‘rules’ that are applied when considering if a product should have a PAR status, and the standard conditions that will be applied to manage a range of risks.

There has been extensive consultation and several revisions of this draft operational policy for PAR products. The draft policy does not negate the need for the ACVM Group to consider each product application on its merits, but it is intended to provide a framework for decisions in the future.

Many concerns expressed over earlier drafts of the policy (see the Summary of Submissions document at http://www.nzfsa.govt.nz/acvm/archive/draft/policies/index.htm) are addressed in later versions. Some of these were concerns over risks that might exist if there were a proliferation of traders and over ‘any person’ being able to trade in PAR products.

The ACVM Group has addressed this by developing a draft standard for traders (currently on the website for public discussion) that will be used as the basis for approval of people and organisations operating in this area. We have also included the requirement for persons operating as traders to have confirmation that they are ‘fit and proper’ persons in the same way that operates for VPC licence holders at present.

This means that registrants must be aware that all New Zealand manufacturers and importers of PAR products, as well as any person or organisation in the PAR supply chain, including wholesalers and dispensing veterinarians, will need to be approved as traders in the future. It is proposed that the policy will be implemented in a cost-effective way by recognising (at no cost) all organisations currently trading PAR products.

Over the next 18 to 24 months the ACVM Group will request a number of audits (initially at no cost) to determine the level of verification that will be required in this area. This information will be used to allow an audit programme to be established. In that time it is expected that the companies trading will develop codes of practice (either individually or collectively), which will be approved under the ACVM Act, to assist them in meeting the requirements in the ACVM trading standard.

One of the other concerns raised has been the lack of a competency standard for traders, especially those at the dispensing end of the supply chain. The ACVM Group notes that many of the products attracting PAR status will also require ‘approved handler’ status under the HSNO Act.

This will mean that people working with the products must be trained to cover HSNO risks (public health and the environment) and maintain their status in order to work with the products. We will discuss this further with ERMA NZ staff to investigate opportunities for co-operation.

Revised fees associated with the Data Assessment Service and regulatory process

With the recent separation of the Data Assessment Service (DAS) from the regulatory process, the ACVM Group has established new fees associated with the regulatory process.

The DAS involves the assessment of data to support an application for registration. The fees associated with this service are based on an estimate of time ($108.00 + GST per hour) that is likely to be taken to complete the assessment. A screening fee of $243.00 must accompany the request to assess the data, unless the applicant is an approved creditor (see page 7). The ACVM Group will then inform the applicant of the estimated number of hours, costs and likely time to complete the DAS.

The regulatory process consists of reviewing data assessment reports and evaluating the risks that must be managed under the ACVM Act 1997. is estimated that this part of the process will be quicker, and therefore attract a lower fee. Fees associated with this process are also based on an estimate of time to review the data assessment reports ($108.00 + GST per hour), plus operational charges and any disbursements associated with the application.

For further information on fees associated with the Data Assessment Service and regulatory process, refer to the website ( http://www.nzfsa.govt.nz/acvm/publications/fees/index.htm ).