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AgVetLink February 2004: Page 2

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Have You Updated Yet?

In our special December registrants’ edition of AgVetLink we urged companies to update their registered products to the ACVM Act as soon as possible, and advised that this must be undertaken before 1 July 2004.

To date, 739 products out of approximately 2500 have been updated. There is a steady flow of updates from some larger companies, but we are concerned that those who have very few products registered may not be aware of the urgency or they are going to submit updates at the last moment.

Again, we advise that if products are not updated by 1 July 2004, it will be illegal to import, manufacture, sell or use products that have not undergone this process. They must be updated to be legally existing.

The ACVM Group has put in place a compliance strategy to manage those registrants whose products are not updated. See the December 2003 special issue of AgVetLink (www.nzfsa.govt.nz/acvm).

SO DON’T PROCRASTINATE – CHIP AWAY and/or GET ON TO IT!

Products that now require registration under the ACVM Act

Some products that are covered by the ACVM Act were not covered under the previous legislation. The products now covered include groups such as plant compound adjuvents (including wetting and sticking agents), pH buffers, drift retardants, and water conditioners.

Most of these products are already covered by the exemption Regulations but, if they are not, proprietors need to be aware that the transitional provisions of the ACVM Act expire on 2 July 2004. The transitional provisions allowed for any substance that was legally existing to continue to be imported, manufactured, sold or used for a period of three years following the implementation of the ACVM Act.

The ACVM Group is using this opportunity to encourage registrants to check any non-registered products to ensure that they do not require registration under the ACVM Act. Registrations must be approved by 2 July 2004 to enable the products to continue to be imported, manufactured, sold or used (see above article).

Any registrants affected are encouraged to discuss concerns with the ACVM Group. Some of these products will also be affected by the HSNO Act and there is room for providing flexibility on labelling for an initial two year period where needed. Registration will require the usual application for registration of a new product, but there may be limited information required where the ACVM Act risks are low.

The ACVM Group has written to all parties who have undertaken class determinations for products in this category to remind them of their obligations under the ACVM Act.

Document update

Completed documents:
The ACVM Standard for Oral Nutritional Compounds has been finalised and is available on the ACVM part of the website.
Updated material also available on the website includes:

• ACVM Registration Information Requirements for Veterinary Medicines in New Zealand
• ACVM New Zealand Labelling Guide for Veterinary Medicines Requiring Registration
• ACVM Registration Standard and Guideline for Target Animal Safety
• ACVM Research Standard
• The definition of oral nutritional compounds
• Information sheet on class determination of veterinary medicines
• Information sheet on class determination of plant compounds
• GRAS process timeline & application form
• ACVM policy on compliance and operating principles Draft standards out for discussion:
• ACVM Standard for Vertebrate Toxic Agents and
• ACVM Standard for Own Use of Agricultural Compounds.