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AgVetLink: Number 51, August 2005

Compliance process

We are often asked about the process used to ensure compliance with ACVM legislation. This is a summary of the 2005 ACVM Group programme.

The ACVM Group compliance monitoring programme has been revised and extended to include regulatory controls implemented since the start up of the ACVM Act. The compliance monitoring programme includes audits, reviews and investigations.

Audits

Audits are the regular, planned and targeted assessments of compliance with regulatory standards (some of which are internationally agreed) and usually include site inspections.

About one hundred inspections are carried out annually for regular reassessment of manufacturers of veterinary medicines, distributors of hormonal growth promotants, and traders in prescription animal remedy (PAR) and/or vertebrate toxic agent (VTA) products. New applicants in these categories are also audited. There is a well-established and generally very knowledgeable stakeholder base with a good level of compliance.

Reviews

Reviews are undertaken to provide the ACVM Group with better knowledge of the sectors it must regulate and to determine the effects of its regulatory actions. Reviews are a relatively new concept introduced two years ago, and the ACVM Group is developing this aspect of compliance monitoring to improve its own competence and contribution as the regulator in the veterinary medicine and agricultural compound sectors.

Reviews may be either targeted to a specific product or have a broad scope to provide a general understanding of an industry segment. They are usually carried out by specialists within the Compliance and Investigation Group (CIG) of NZFSA.

Proposed reviews include the following topics:

•         Import clearance processes at the border

•         Levels of compliance with conditions placed on approvals for research

•         Levels of compliance with conditions placed on products exempt from registration under the Act

•         Levels of compliance with conditions placed on provisional registrations

•         Levels of compliance of oral nutritional compounds and fertilisers in Schedules 4 and 5 respectively of Regulations under the ACVM Act

•         Levels of compliance of homeopathic and herbal products with the Regulations

•         Levels of compliance of activities or procedures carried out under codes of practice approved under the ACVM Act.

The ACVM Group will need to use a priority ranking for conducting reviews because of  the time required and complexity of the task. With current resources, two reviews can be carried out in a year.

Investigations

Investigations concern allegations or suspicions that non compliance or illegal activities under the Act are occurring. Such allegations or suspicions are always followed up by the Group. While most investigations are able to be resolved through the provision of guidance and/or warnings by the ACVM Group, some require further action.  In the last year six such cases have been referred to the CIG who lead any prosecutions taken (see page 5).