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AgVetLink April 2005 

PAR trader approvals update 

The ACVM Group is completing the approvals of prescription animal remedy (PAR) traders. The recent series of workshops (see page 9) for veterinarians and stakeholders around the country indicated we have not communicated our process and time frames sufficiently well. This is a summary of progress so far.

The key guiding principle we have adopted in defining what constitutes trading under this programme is the activity of selling a PAR to an end-user. Although three distinct groups of traders have been identified, the requirements covering their activities are common to all groups.

Registered veterinary practices

Registered veterinary practices have been approved as traders, and we will send letters and a certificate to the approved practices as soon as possible. We are aware that in some cases practices have listed a number of veterinarians having overall responsibility for the PAR trading system and our certificate will reflect that situation. However, we are particularly interested in the person responsible for the retailing activity (i.e. the person who manages PAR stocks, specifies the lay staff who can dispense PAR products, trains those staff and carries out the internal audits to confirm compliance to the ACVM Standard for Prescription Animal Remedy Veterinary Medicines).

We consider that, in most administrative systems, overall responsibility will be placed with one or two people who may or may not be veterinarians. As discussed in previous AgVetLink articles, the requirements of the Veterinary Council of New Zealand for maintenance of the registration of a veterinarian obviate the need for a ‘fit and proper person’ assessment of veterinarians. If the responsible person is a non-veterinarian, fit and proper person assessment is required.

Spot checks for compliance with the ACVM Standard for PAR Veterinary Medicines by traders will be made under an inspection sample plan to be implemented during 2005. During these checks the actual arrangements in regard to the overall responsibility for the trading activity will be clarified.

Registrants of PAR products

Registrants of PAR products are traders under this programme if they sell products directly to end users under a veterinary prescription or authorisation. If registrant traders are also manufacturers subject to regular GMP inspection, they will be approved as traders automatically, and the GMP inspections will be modified to include stock management to review trading practices. Registrants who are traders of PARs and who are manufacturing will also receive a certificate and letter confirming approval in the near future.

Some registrants who are neither veterinarians nor manufacturers have applied for approval as traders of PARs for sale directly to end-users. These applicants will be required to assign a responsible person who will be assessed as fit and proper, and their sites and operating systems will be inspected for compliance with the trading requirements in the ACVM Standard for PAR Veterinary Medicines. The ACVM Group is in the process of contacting these applicants.

Veterinary wholesalers

Some veterinary wholesaler organisations and sites have been inspected for a number of years and approved by the ACVM Group for participation in the rigidly controlled hormonal growth promotant (HGP) distribution process. These organisations, which have been found to comply with the trading requirements in the ACVM Standard for PAR Veterinary Medicines and have been approved as PAR traders, will receive a certificate and letter confirming approval as soon as possible.

Some wholesales have applied for approval as new traders of PARs. These applicants have been contacted and their sites and operational systems are being inspected for compliance with the trading requirements in the ACVM Standard for PAR Veterinary Medicines. On completion of the inspection and fit and proper assessment of the responsible person, approval will be confirmed by letter and by ACVM certificate.

Once approved, traders will be placed on a public register, which will be posted on the ACVM website.