- PDF Version ( 94K) - Print Friendly - Help

Compliance

7 Monitoring activity

Monitoring consists of programmes run for the purpose of the assessment of compliance with an ACVM performance standard, the ACVM Act, or its regulations. Compliance with ACVM requirements in most cases is implemented as a condition of an authorisation such as product registration. The condition is directed at the point where it is considered most appropriate and/or effective to manage identified risks and hazards down to an acceptable level. A specific regulated party (for example importers, manufacturers, sellers or users) is nominated in the condition.

7.1 Regular programmes

A number of regular programmes are already in place, such as the programme covering the ACVM Standard and Guidelines for GMP, which applies to manufacturers of registered veterinary medicines and vertebrate toxic agents.

Regular programmes will be added wherever:

• there is an international expectation or requirement (as in the case of GMP), or

• there is an agreed New Zealand expectation as in the manufacture of certain vertebrate toxic agents, or

• where information shows that there is a need for an ongoing oversight of the activity in order to effectively manage the risks or to provide regulatory assurances.

Where a regular programme is in place and there is a breach of the conditions of the legislation, it will be a standard response for the ACVM Group to require an increase in the frequency of the programme until the required level of confidence is restored.

7.2 Short-term programmes

While short-term compliance programmes may be used case by case for a variety of reasons, we expect them to be used mainly in two areas. The ACVM Group will institute short-term programmes for those areas where there are reasonably significant breaches that show a lack of awareness of roles and responsibilities under the ACVM Act. They will also be used where new conditions that rely on compliance to an operating plan are developed. This will ensure that the plan is understood and is adequate.

Short-term programmes are post-approval checks. They ensure that the conditions placed on an approval are understood and are having the desired effect. They act as confidence building checks to confirm that specific instructions are complied with over time.

In line with the regulatory model, the activity is likely to be outsourced to one of a number of TPAs⁴. In some cases, the staff will need to be specially trained (eg MAFBNZ staff at the border). They may also be given powers under the ACVM Act by way of being appointed as ACVM Officers⁵.

7.3 Other monitoring

Monitoring programmes run by other groups within NZFSA will provide information for ACVM Group compliance.

⁴ NZFSA has a number of service providers in this area including MAFBNZ, NZFSA Verification Agency, IANZ etc. It is expected that programmes will be tendered to one of the existing agencies on the basis of their ability to provide an effective service.

⁵ ACVM Officers appointed under the ACVM Act must be State Sector employees.