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AgVetLink Special issue for Veterinarians May 2006

PAR Traders:

A look at their understanding of and compliance with the ACVM Standard for Prescription Animal Remedy Veterinary Medicines

A review of prescription animal remedy (PAR) traders will be carried out this year to ascertain the level of understanding of and compliance with the ACVM Standard for Prescription Animal Remedy Veterinary Medicines and ACVM Expectations for Approved Traders of PAR Products.

Review

The review will examine the following areas:

Quality system

Is there a person responsible for the operation of the quality system? Is the system documented? Is there training for staff operating under the system? Are internal reviews of the quality system carried out at regular intervals?

Transportation

An assessment will be made on transportation arrangements for all PAR products. Are they transported in an appropriate manner for their PAR classification? Are they protected from the weather with appropriate temperature maintained? Are Class II and Class III products transported securely locked? Is the procedure documented?

Receipt and storage

An assessment will be made on the documented receipt of PAR products and the arrangements in place for their storage.

Dispensing

If dispensing is carried out, is there an appropriate designated area set aside? Is documentation and record keeping appropriate?

Training

Where the trader is neither a registered veterinarian nor pharmacist, the trader must be able to demonstrate (through training records) competence to operate within the quality system and carry out specific dispensing activities.

Documentation

Documentation includes electronic and hard copy versions of current regulatory standards and guidelines, standard operating procedures, and records of activities including transactions.

Sample

The Approvals and ACVM Group has consulted with the New Zealand Veterinary Association (NZVA) and the Veterinary Council of New Zealand (VCNZ) to decide how the sample of PAR traders will be chosen this year. It has been agreed to focus on veterinary practices because non-veterinary traders are audited upon entry to the list of approved traders of PARs, and registrants and manufacturers wishing to sell PARs to end users will be audited as part of their Good Manufacturing Practice (GMP) audits.

The veterinary practices to be reviewed will be selected to give a range of the various practice types in New Zealand but will be weighted to emphasise the areas with the greatest volume of PAR trading, where issues relating to food safety and risk to trade will occur. Therefore, this year five dairy practices, three sheep and beef practices, two equine and two small animal practices will be randomly selected. Upon selection the practice will be contacted to confirm it fits into the appropriate category and to arrange a time for the inspection to take place. In the case of mixed practices, only the area in the selection category will be inspected.

Analysis

Following the visits an analysis will be made and reviewed with VCNZ and NZVA. A public report will then be made available.

It is anticipated that such reviews will be conducted annually because they play an important part of giving assurance to international trading partners that we are managing risks associated with trading in PARs.

A similar procedure for practice selection will be used in subsequent years unless the findings indicate there is a poor understanding or non-compliance with the ACVM standard.

The ACVM Standard for Unregistered Veterinary Medicines Requiring Veterinary Overview will be available on the website this month.

Thanks to:

• veterinarians and VCNZ for your input into this document

• the working party on specifications for compounding.

(www.nzfsa.govt.nz/acvm)