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ACVM Amendment Bill

The NZFSA is working through the submissions received on the discussion paper Proposed Amendments to the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, which was released in April (by MAF). We will use the submissions received to help us develop the policy for the Amendment Bill.

As with the submissions received on previous discussion papers on the ACVM Act, the summary of submissions will be accompanied by our response to those sub-missions. The NZFSA is hoping to send out this document to submitters before the end of the year. It will also be available on the NZFSA website.

The proposals that require the most policy development are:

• the purpose of the Act (the proposal to add risks to food safety),
• provisions within the Act for data protection,
• cost recovery and penalties, and
• efficacy.

Staff may need to contact submitters on an individual basis to discuss points made in their submissions.

Once the NZFSA has finalised its policy on the required ACVM amendments, it will need to get policy approval from Cabinet to proceed with the proposed amendments. If the necessary approvals are gained, the Bill will then be drafted and introduced into Parliament.

At this stage, the NZFSA is hopeful that the Bill will be introduced by the middle of next year. After the Bill has had its first reading it will be sent to a Select Committee. The Select Committee will call for submissions on the Bill and will be required to report back to Parliament within six months.

AMENDMENT TO ACVM REGULATIONS

The amendment to the ACVM Regulations (additions to the list of exemptions and to the GRAS list) was delayed because of the general election. Now that the new Government has been formed and the Cabinet is meeting, the amendment can be progressed. Allowing for departmental consultation and drafting, we expect the amendment to the Regulations to be passed in November.

In the June 2002 issue of AgVetLink, a draft policy on publishing label content on the ACVM Group's website was advised, and registrants were invited to provide any comments or concerns. As none were received, the policy is now effective.

When a product is approved for registration under the ACVM Act, applicants will be requested to forward an electronic copy of the label content to the ACVM Group. Our preference for the format of the label is either as an MSWord or a .pdf version. (We believe that one of these versions should be available from your printer.)

When the product is registered, the label content will be published on our website (the public register). This will be done in much the same way as the National Registration Authority in Australia publishes labels on their website.

Should applicants wish to defer publishing, e.g. for marketing reasons, they must notify their intentions when they receive the approval notification and advise a timeframe. NB: Six months from the date of registration will be the maximum period of deferral.

Information waivers

The ACVM Group has finalised the information waiver process. Information waivers are required where applicants believe that they can meet the requirements of the standards and guidelines by alternative means, and should be done in advance of the application. In most cases a reasonable technical argument or data are required in support of an information waiver request. Information waivers are charged on the ACVM Group hourly rate.

Details of the process can be found on our website at http://www.nzfsa.govt.nz/acvm/subject/registration/information-waivers.htm

Please inform Gill Wilson of any change to your contact details. E-mail: gill.wilson@nzfsa.govt.nz