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AgVetLink: Number 68, June 2008

AGCARM Meetings

Meetings of the AGCARM subcommittees were held 10 June 2008 to clarify and discuss the proposed ACVM regulatory changes (see consultation document on the website). It was noted that proposed regulations will apply to all ACVM products (exempt and registered). A brief summary of the discussions follows.

Crop Protection Subcommittee

Manufacturing

For the most part, it was going to be business as usual in regard to manufacturing because the changes were primarily transferring existing requirements in ACVM standards into regulations. However, there were proposals for some fundamental changes in the areas of information transfer and own use. In particular, the proposed obligations on third parties were discussed.

Clarification of the definition of 'responsible manufacturer'

The registrant stated in the manufacturing specification would be responsible for overall quality control and product release and, therefore, should be considered the responsible manufacturer. Only the responsible manufacturer would be put on the public register.

Overseas manufacturers

The New Zealand registrant or agent would be held responsible for complying with the proposed ACVM (Manufacturing of Agricultural Compounds) Regulations, so registrants should have systems in place to have confidence in any overseas manufacturers contracted.

Animal Health Subcommittee

Clarification of operating plans

The term ‘operating plan’ refers to approval under section 28 and would be used in a number of circumstances. Once the requirement for an operating plan is prescribed in the regulations, the ACVM Group will prepare guidance for each industry sector in regard to the terms they are already using.

Approval of active ingredient (AI) manufacturers

There was some confusion because the public discussion document was asking if AI manufacturers should be approved and the subcommittee was under the impression that AI manufacturers were already being approved as part of registration. The ACVM Group confirmed that it did not require official approval of AI manufacturers but had identified international trends and concerns that could lead to such a requirement.

Labelling

The reasons for labelling requirements being transferred from the guidelines on advertising and labelling into the regulations on manufacturing were discussed and accepted as reasonable and appropriate.

Information transfer

The subcommittee wanted clarification of the concept of primary message, and expressed concern that the requirement to include warnings in the primary message could cause considerable difficulty and uncertainty if there was no clear guidance as to the scope and detail of warning that should be included. The ACVM Group took note of this and agreed that it would have to develop adequate guidance in this area.

Promoting off-label uses

Both subcommittees noted that the most likely source of reliable information about the likely consequences of off-label use would be the registrant, who is currently prevented from promoting the product for off-label uses. They were advised that this was one of the reasons why information transfer regulations are being proposed. NZFSA would like to provide a safe and legal context in which any party, including the registrant, can disseminate information that would be helpful for users.

Timeframe

Both subcommittees asked about the timeframe for the regulations. they were advised that there was a window of opportunity to make regulations before the end of the year, but the elections could jeopardise this and the regulations might not be made until mid 2009.

Restricted access policy for veterinary medicines

After the proposals for regulations were discussed, the animal health subcommittee discussed the proposed restricted access regime for veterinary medicines. It was noted that the work on the restriction categories has progressed and resulted in the current proposal, ie unrestricted and restricted (in 3 groups). Developing the rules for grouping particular products was the next stage in the process. In the meantime, joint ACVM Group, Veterinary Council of New Zealand (VCNZ) and New Zealand Veterinary Association workshops would be held for veterinarians and registrants as soon as VCNZ developed guidance to veterinarians on product groups.