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AgVetLink December 2003

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Recent events

• ACVM workshops were held in Wellington recently to work through industry concerns on updating products to the ACVM and HSNO Acts and come up with possible solutions. A special edition AgVetLink covering the outcomes of the meeting is being prepared for registrants. ERMA New Zealand staff were an important part of the workshops.
• An AVMAC meeting was held in Wellington on 20 November 2003. The revision of the ACVM Group Operational Policy on Compliance and the new ACVM Standard for Oral Nutritional Compounds were endorsed by AVMAC at the meeting. Both documents will be available on the website shortly.
  
  AVMAC also discussed the first draft of the ACVM Standard for Vertebrate Toxic Agents (known as vertebrate pest control products under the Pesticides Act). This standard is based on the PAR standard and introduces the concept of ‘classes’ for VTA products (see article on page 3). The draft is now on the website for initial consultation.
• Maree Zinzley and Debbie Morris from the ACVM Group met with the Executive Committee of ARPPA and also attended the ARPPA AGM to give a presentation on items of interest regarding the ACVM Act implementation.
• Australia/New Zealand VICH Management Committee meeting was held in Wellington on 4 December. The agenda included a review of the 13 th Steering Committee meeting (Washington, October 2003), agreement on the ANZ position for VICH activities post-2005, initial arrangements for the VICH 3 conference to be held in Washington prior to Easter 2005, and discussion on issues for the next meeting of the Steering Committee in Tokyo, May 2004.
  
  Ross Henderson, VMDA (Australia); Peter Holdsworth, Avcare (Australia); Jack Richardson, Agcarm; Gabrielle Deuss, ARPPA; Tim Dyke, APVMA (Australia); Sue Thomas, ERMA New Zealand; and Debbie Morris, ACVM Group, attended the meeting.
• Australia/New Zealand Registration Management Committee met in Wellington on 4 December to progress discussions on the harmonisation of registration requirements between the two countries. Items for discussion on the agenda included:
  • Trans Tasman Mutual Recognition Agreement recommendations – discussion on opportunities for cooperation
  • mutual recognition of risk assessments for companion animal products
  • mutual recognition of GMP for veterinary medicines
  • development of a memorandum of understanding for compliance issues.

Register of nutrients with pharmacological or therapeutic applications

In October 2002 the ACVM Group determined that any veterinary medicine containing green-lipped mussel, deer velvet, shark cartilage, chondroitin sulphate, glucosamine or glycosaminoglycans would be considered therapeutic substances and require registration to be legally imported or sold in New Zealand. The determination was in response to overwhelming numbers of compliance incidents relating to anti-inflammatory and joint therapy claims made in association with the products.

At the time of the determination, the Group indicated it was willing to consider the substances as appropriate for inclusion as additives on the Generally Recognised as Safe (GRAS) register that forms Schedule 7 of the ACVM Regulations 2001. Inclusion on the list would mean that such substances could be included in exempt oral nutritional compounds up to the specified maximum level.

The Group now recognises that these substances are not appropriate to be considered for inclusion on the GRAS register because they do not meet the definition of ‘feed additive’. Instead, the Group has developed a Register of Allowable Nutrients with Known Therapeutic Uses in Exempt Oral Nutritional Compounds. The register lists the substances that previously required registration when included in any veterinary medicine but now qualify for exemption.

It also specifies the circumstances under which exemption will be considered, e.g. target species and level of inclusion.

The register only applies when substances are included in complete foods and not in supplements, which will continue to require registration.

The register is available for viewing on the ACVM website (www.nzfsa.govt.nz/acvm) and is located with the ‘class determination‘ information.

Registrants should note that the ACVM Group is in the process of developing a Specified Requirements Product Standard specific to oral nutritional compounds containing levels of glucosamine etc. in excess of those permitted. The standard will set out exactly what data and information are required to secure registration of these products and will allow rapid registration at reduced expense over the current system.