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AgVetLink April 2003

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AVMAC meeting - 27 February 2003

This was the 21 st meeting of AVMAC and, as usual, the agenda was a full one.

• Chris Boland presented an update on the management of antibiotic resistance project. This is now posted on the ACVM Group website ( http://www.nzfsa.govt.nz/acvm/topics/antibiotic-resistance/index.htm ).
• The meeting was advised of two new codes of practice approved under the ACVM Act - one covering the writing of prescriptions for PAR products (New Zealand Veterinary Association and the Veterinary Council of New Zealand) and the other covering the use of PAR products by grooms travelling with horses. A full list of the ACVM Act approved codes of practice can be viewed on the website ( http://www.nzfsa.govt.nz/acvm/registers-lists/cop.htm ).
• Meriel Watts, consumer representative on the group, was invited to present a paper for discussion. This proved to be a useful addition to the meeting.
• There was considerable discussion on submissions to date on the proposed operational policy for the control of PAR products and the related issue of the development of a standard covering 'operating instructions'.
• Bruce Burdon provided an update on the likely timing of the ACVM Act Amendment Bill and changes to the exemptions/GRAS regulations.

Review of AVMAC membership

The meeting was asked to consider the membership of AVMAC given that the ACVM Act is now in force and that the group has been operating for a number of years. We want to know if there are organisations or individuals who consider that they should be represented on AVMAC either in addition to the current membership or as a replacement. If you have any suggestions or comments please forward them to Gill Wilson (email: gill.wilson@nzfsa.govt.nz).

Adoption of VICH guidelines

The following are final guidelines that were endorsed by AVMAC members at the meeting on 27 February 2003.

GL28 Safety studies for veterinary drug residues in human food: Carcinogenicity studies. (October 2003)* 

GL 31 Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat dose (90 days). (October 2003)* 

GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing. (October 2003)* 

GL33 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing. (October 2003)* 

The NZFSA proposes to apply these Step 4 guidelines (as appropriate) in its standards and guidelines for the registration of veterinary medicines under the ACVM Act and Regulations, and in any related legislation. Details of the VICH process and the finalised guidelines can be found on the website (http://www.nzfsa.govt.nz/policy-law/vich/guidelines).

Communicating with registrants and consultants on applications

It is common practice for applicants to engage the services of a regulatory consultant to prepare applications and to act as the primary point of contact with the ACVM Group during this time.

It is ACVM Group policy that where the nature of any correspondence is such that the Group deems it necessary for the registrant to be informed directly, such as where an application is deficient and is likely to be declined, it will be addressed to the registrant in addition to the consultant.

This is to ensure that communication is timely and to avoid any opportunity for misin-terpretation.

Applicants should ensure that the ACVM Group is informed if a consultant is to be the primary point of contact for any particular ap-plication.

Where there is any uncertainty, the ACVM Group will communicate directly with the registrant.