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AgVetLink: Number 51, August 2005

Antibiotic products review

The ACVM Group is instigating reassessments of all antibiotic products that are prescription animal remedy (PAR) veterinary medicines. After considerable dialogue between the Group, the Ministry of Health, Medsafe, the veterinary pharmaceutical industry, the veterinary profession and other technical experts it has been grudgingly accepted that the risk management role of veterinarians is made more difficult by advertising PAR antibiotic products directly to end users.

The ACVM Group has publicly announced its intention to impose a prohibition on such advertising via a new condition of registration (see page 8). However, limitations in the ACVM Act cause logistical difficulties in doing this.

The only mechanism provided in the ACVM Act is a reassessment under section 29. This requires a process that is focused on individual products (or at best on products that are very much alike). Each registrant must be individually contacted and advised that a reassessment is being considered. The reassessment itself must be conducted like a registration, requiring gazette notices and consultation.

The ACVM Group has combined products according to antibiotic active ingredients and formulation type and sent letters to registrants notifying them of the reassessments. Because there are 67 groups, there will have to be 67 reassessments. The expected outcome is exactly the same for all the groups, so the ACVM Group is trying to rationalise the time and process to facilitate the application of the new condition. In the meantime, the registrants are well aware of what is going to happen and are being advised to adjust their advertising programmes accordingly.