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Compliance

4 Scope of compliance

Compliance is about checking on an ongoing basis that the purpose of the ACVM Act is being achieved as effectively as possible. It covers the whole supply chain for agricultural compounds and veterinary medicines from importation or manufacture, distribution, sale and use.

4.1 Authorisations

The main activity under the ACVM Act is the provision of authorisations (approvals). We provide authorisations for people, places, organisations or premises, processes and for product(s).

• People and/or organisations authorisations cover:

- ‘users’ of certain groups of products, eg hormone growth promotants (HGPs), vertebrate toxic agents (VTAs)

- suppliers of certain groups of products, such as the approval of traders in restricted sale products

- ACVM Officers and recognised persons who can be appointed or authorised under the ACVM Act to undertake a range of functions from regulatory compliance activities to data assessment as a commercial service for applicants.

• Places or premises authorisations under the ACVM Act includes sites approved for levels of GMP and responsible manufacture, and certain research facilities to carry out trials.

• Process authorisations include the recognition of Operating Plans. For example:

- GMP

- restricted sale products.

• Product authorisations include:

- exemption by regulation (from the requirement to be registered) of groups of trade name products

- registration of products

- import clearances

- approval under special circumstances

- listing as generally recognised as safe (GRAS).

4.2 Prohibitions

The ACVM Act provides the power to prohibit the use of certain products or substances as agricultural compounds. This is done by regulation but it is not commonly used as most concerns can be managed by varying the conditions on an authorisation.

4.3 Suspensions

The ACVM Act provides the power to suspend an approval of products or substances as agricultural compounds or approvals/recognitions of people and/or organisations, places or premises.

4.4 Pre-approval checks

In some cases a ‘pre-approval’ step is required before approval. This usually consists of the provision of information rather than a physical check, but physical checks are undertaken where needed. GMP provides examples of this -- where a product is being added to the list of products of a similar type to be manufactured at an already approved facility, approval is usually given on the basis of previous knowledge of the site and its systems. If it were a brand new manufacturing facility, there would be a series of physical and/or verification checks prior to approval.

4.5 Post-approval checks

This is the area most commonly referred to as ‘compliance’. It consists of information collection and collation as well as a range of physical checks. It covers the activities already outlined under approvals and prohibitions. Checks can be of specific products across the whole supply chain or of specific parts of the supply chain for a range of products. The components (monitoring, surveillance and reality checks) are more fully explained below.

The following figure is a model of the interrelationship of the traditional compliance activities.

4.6 Application of Sanctions

The ACVM Act provides a range of sanctions and powers that can be applied at the various stages in the process.

• Reassessment of approvals: The Act provides criteria for the reassessment of registered products and the actions that can be taken. As groups of products are exempted by regulation, changes to exemptions are also by regulation.

• Suspension of approvals: Trade name products registered under section 21 of the Act can be suspended for a period of up to 3 months on the basis that any conditions imposed on the registration are not being complied with. The Act also provides the power to suspend/revoke an appointment/recognition of persons or places.

• Requirements to provide information: ACVM Officers can request samples and information where there are concerns about compliance. They can also issue ‘hold’ notices on products for up to five days.

• Inspection: ACVM Officers have the power to undertake inspections when there are reasonable grounds to believe there is non-compliance with the ACVM Act.

• Prohibition notices: ACVM Officers have the power to prohibit the manufacture, sale, import and/or use of a product by any party where there are reasonable grounds to believe that there is non-compliance with the ACVM Act. Prohibition notices need to include the actions that are to be taken to remedy the non-compliance to the satisfaction of the ACVM Officer. Prohibition notices will be issued following an inspection.

• Search warrants: Inspectors may be issued search warrants that provide further powers of entry and the power to seize and detain products of concern.

• Import clearance: Where there are concerns about non-compliance of products at the point of importation, clearance will not be granted and regulatory action will be taken in the biosecurity transitional facilities

4.7 Investigation

All complaints or allegations of non-compliance will be investigated by the ACVM Group. Should there be a breach of the ACVM Act and/or ACVM Regulations 2001, the ACVM Group’s immediate goal is to return the breach to compliance as soon as possible. The ACVM Group will not shy away from prosecution where it is required. A range of sanctions are available under the ACVM Act--declining clearance at the border, suspension and withdrawal of registration approval and the use of prohibition notices which detail requirements that must be complied with before normal business can resume.

As a result of the investigation, the ACVM Group has the power under section 35G to direct an agricultural compound to be recalled for rectification, disposal or destruction if the compound does not comply with the requirements of the Act and/or Regulations or the non-compliance would result in serious or significant breaches to the ACVM risk areas.

4.8 Prosecution

Cases are investigated, documented and prepared by CIG. The decision to prosecute and the process of taking prosecutions are conducted in accordance with NZFSA prosecution policies. The ACVM Group and CIG will work to the following principles in considering prosecutions under the ACVM Act:

• The prime purpose of prosecution is to act as a deterrent for the parties concerned and for others in related industries. It is therefore important that successful prosecutions are given the maximum possible exposure in relevant media, and that agreements providing protections or confidentiality are not entered into without due consideration.

• New or revised legislation will need to be ’tested’ in the courts. An initial prosecution will set the legal precedent for penalties in the future in the specific legislation and in any related legislation.

• NZFSA will cooperate with other regulatory agencies in New Zealand to the maximum extent possible to ensure the most effective use of Crown monies and of NZFSA people resources. Wherever possible NZFSA will work on complementary investigations from the outset.

• NZFSA will have an open dialogue with overseas regulators where there is a likely impact from a breach of New Zealand legislation.

• Prosecutions will be considered against the NZFSA CIG Prosecution Policy.

4.9 External review

External review relates to government or overseas competent authority review of the New Zealand competent authority’s activities. Such reviews are not usually targeted at ACVM Act activities specifically but they do usually cover the approval and controls of agricultural compounds and veterinary medicines in the scope of the overseas competent authority’s review as a risk area to be managed.