This content is current only at the time of printing. This document was printed on 10 September 2020. A current copy is located at http://www.xlg888.com/node/1079
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How we monitor compliance
The APVMA monitors the Australian market to confirm the compliance of authorised agvet chemical products and active constituents.
Maintaining compliance with the Agvet Code is the holders responsibility?
APVMA monitoring work can include remotely assessing and visiting holders, manufacturers, wholesalers and retailers of agvet chemicals. Monitoring compliance helps the APVMA identify emerging issues so corrective actions can be undertaken promptly, which helps protect the health and safety of people, animals, plants and the environment—as well as Australia’s trade interests.
Marketed product labels (MPLs)
Holders are responsible for ensuring their labels comply with the appropriate labelling code. The APVMA monitors marketed product labels by reviewing copies of labels and inspecting labels at the point of retail sale.
Products may be specifically targeted where changes to labels have been required by the APVMA as a result of?chemical review, or if a specific concern has been raised.
Low-risk issues are addressed cooperatively with holders using education and negotiation. Higher-risk issues where labels have significant errors that could lead to harm are prioritised by the APVMA for compliance or recall action.
A compliance campaign may be undertaken if the APVMA identifies that label non-?compliance appears widespread within a particular industry or with a particular product type.
A compliance campaign aims to raise compliance awareness and may include a range of activities including onsite monitoring visits, direct mail-outs, production and distribution of educational material, face to face presentations and targeted education seminars.
The need for campaign activity is based on:
- consideration of potential or actual risk
- frequency of allegations received about a manufacturer, holder or product type
- pro-active monitoring of the market.
The aim of any compliance campaign is to efficiently assist entities in returning to compliance and remaining compliant.
Audits are planned events and may include a combination of desk-based auditing and field-based auditing activities. Companies selected for audit will receive sufficient notice of the audit to allow for preparation.
The purpose of compliance audits is to:
- check compliance with conditions attached to an active constituent approval, product registration, permit approval or manufacturing licence
- evaluate those conditions for enforceability, comprehension, and ease of assessment for business-improvement purposes
- evaluate whether compliance with the conditions attached to an authorisation are assisting to protect human and animal health, agriculture, the environment and trade.
Preliminary audit findings will be communicated to the auditee and there will be opportunity for comment and discussion. All audits will conclude with a final written audit report. A copy of the final audit report will be provided to the auditee for their records.
If the audit identifies matters of non-compliance, the APVMA will consider what action is necessary ensure compliance.
Products in the market
Sampling and testing agvet chemicals
In some circumstances, the APVMA may obtain samples from the market for analytical testing.
Sampling and testing provides the APVMA with information about a product’s constituents and quality. Information resulting from sampling and testing may be used to guide future compliance activities—or be part of a broader sampling and testing program.
For example, while undertaking a compliance campaign the APVMA may obtain chemicals to check their quality and the active constituent’s concentrations.
The APVMA monitors agvet product advertising and other promotional material in Australia to ensure it complies with the Agvet Code—this includes investigating reports of alleged non-compliant advertising.
This means holders, retailers and other suppliers need to ensure all promotional materials and product advertising complies with Agvet law. Promotional materials and advertising include print, online, radio, television or other mediums.
In general, the APVMA and its employees are not authorised to—and will not—provide advice about whether or not a particular current or future advertising or promotional claim would give rise to breaches of any of provisions of the Agvet Code. Persons responsible for the advertisement or promotional materials should seek their own legal advice.
Drop shipping is a retail fulfilment method where a store or an online retailer does not keep the products it sells in stock. When an online retailer sells a product, it purchases the product from a third party and then has it shipped directly to the customer from the third party. In some cases customers are not aware that they are purchasing from an online drop shipper.
If you purchase agvet chemical products online, remember to check that the products are APVMA registered and approved prior to purchasing. APVMA registered products have a registration number on the product label.
The APVMA recommends you should enquire with the online seller directly and ask for the APVMA registration number for the product you are considering purchasing. If the seller is not able to provide the APVMA registration number for the product, we advise you to exercise caution and consider purchasing the product elsewhere.
If you purchase agvet chemical products that are not registered or approved and the product is supplied from an overseas source, it may be seized at the Australian border and referred to the APVMA for compliance and enforcement action.
It is an offense to import agvet chemical products that are not APVMA registered. It is also an offense to import active constituents that are not approved.