- PDF Version (609K) - Print Friendly - Help

AgVetLink: Number 58, October 2006

Veterinary Wholesalers (PAR Approved Traders) Audit

Background

Approval of trading entities is the tool the Approvals and ACVM Group uses to ensure that prescription animal remedy (PAR) products are being managed according to the ACVM Standard for Prescription Animal Remedy Veterinary Medicines and the conditions of registration for such products.

PARs are registered subject to conditions under section 21 of the ACVM Act. A condition applied to PAR class 1 trade name products restricts their sale subject to a prescription or authorisation from a veterinarian. This condition manages the major risk, which was identified to be at the point of sale to the general public, i.e. to the person who will use the products to treat animals.

PAR products may be sold by veterinarians directly or by ‘trading entities’, which fill veterinary prescriptions and subsequently sell these to the end user. Trading includes a number of activities – general sale and sale to specified/approved persons, wholesale and retail sales transactions as well as distribution, transport and storage, and gifting or offering as samples.

All veterinarians have been deemed as approved traders by the Approvals and ACVM Group. Veterinarians are subject to annual renewal of their registrations by the Veterinary Council of New Zealand and are subject to the Veterinarians Act 2005. Veterinarians are considered, through their training and experience in current practice, to meet the requirements of the ACVM standard and registration as traders.

Veterinary wholesalers distribute PAR products to veterinary practices and may sell directly to end users under the prescription or authorisation of a veterinarian.

Audit

From mid 2005 through mid 2006, entry audits of veterinary wholesale traders were performed by a third party agency, AgriQuality. Using a checklist agreed with the ACVM Programme Manager, eight trading entities were inspected against the ACVM Standard for Traders of Prescription Animal Remedies (PARs) as part of the implementation of this standard.

To date four companies have been approved, one company has an interim approval due to previous experience with controlled drugs under the auspices of the New Zealand Ministry of Health, one company still has to be audited and the balance are addressing deficiencies noted during their audit. Those traders not approved have been advised not to trade PAR products until their approval has been granted.