This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/130
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Powers to manage risk or enforce compliance
The ability to recall defective or noncompliant (including unregistered) products is fundamental to risk management. The term ‘recall’ does not refer just to the retrieval or return of products from the marketplace or consumers. Recalls can also include formal requirements or notices not to supply or to stop supply.
The full suite of powers available to the APVMA for recalls is detailed in section 101 (Recall of unregistered products), section 102 (Recall of registered products) and section 103 (Recall of products with unapproved labels) of the Code Act.
Recalls and similar powers address product risk and are generally used by the APVMA solely as a precautionary protective measure. Although the issue of a recall may impose a burden on a product holder or supplier, recalls are not intended to be punitive.
The APVMA has developed a regulatory guideline (Compliance and enforcement—stop supply or recalls) to assist people and companies to determine whether a recall is required and how to recall products effectively.
The costs of any aspect of a recall (voluntary or compulsory) are the responsibility of the person or company. This includes costs for any advertising needed to mitigate risk as part of a compulsory recall.
When deciding whether advertising a product recall is required, we consider the ability of the responsible company to contact all affected parties. For example, when a recall relates to an agvet chemical product with an identified lack of efficacy, and the product is distributed by mail order directly to end users, we are likely to require direct correspondence from the supplier to each customer, rather than advertisements in national media. If the product is distributed through retail outlets to the general public, we are likely to require notices at the point of sale and advertisements in print media to ensure an effective recall.
A compulsory recall of a product involves oversight by the APVMA. Compulsory recalls are undertaken to ensure the safety of people, animals, the environment and international trade.
Compulsory recalls are issued by the APVMA when:
- a risk to the public or environmental health exists
- the product in question is unregistered
- voluntary action is insufficient to mitigate risk and therefore an unacceptable risk presents.
A recall notice lists the actions a person or company must take, including:
- the level of recall (wholesale, retail or end user)
- the future fate of the material (disposal, export etc.)
- the advertising or dissemination of the recall notice (local or national advertising, including in newspapers or trade publications)
- the form and wording of any correspondence or advertisement informing affected parties
- the timeframe for recall actions.
However, where needed, we may use powers from the agvet legislation which includes powers to issue notices to produce, attend or substantiate claims and representations, and the execution of monitoring and investigation warrants.
Seizures of evidence
An APVMA inspector can seize any item that they believe on reasonable grounds to be evidence of an offence or contravention. The inspector does not need to return the seized item if possession of the item would be an offence. We can also organise the disposal of seized items if that is appropriate; however, we will take steps to return an item for subsequent disposal by the owner if necessary. Further information about APVMA seizure powers is available in the Seizures factsheet.
Other compliance related programs
Manufacturing quality and licensing
The manufacturing quality and licensing (MQL) section of the APVMA conducts specialist compliance activities for veterinary chemical products. The MQL section oversees two schemes that regulate veterinary chemical product manufacturing:
- the Manufacturer’s Licensing Scheme (MLS) for veterinary chemical products manufactured in Australia
- the Overseas GMP Scheme for veterinary chemical products manufactured overseas.
Ultimate responsibility for meeting these quality objectives lies with the manufacturing company’s senior management, but the participation and commitment of all staff at all levels within the manufacturing organisation is vital. To achieve quality objectives, the manufacturer must have in place a comprehensive, adequately resourced and correctly implemented system of quality assurance that incorporates the principles of GMP.
The MQL section also monitors the GMP compliance status of Australian and overseas agvet chemical manufacturers. Manufacturer compliance with GMP is a necessary prerequisite to gain and maintain veterinary chemical product registration and to gain relevant export certificates. The MQL section may choose when to intervene if noncompliance is identified or refer the matter to our Compliance section for further consideration.
The APVMA authorises third-party GMP auditors, who conduct periodic audits of manufacturers of veterinary chemical products in Australia and overseas. Manufacturers usually select an auditor from the list of APVMA-authorised GMP auditors. However, we reserve the right to nominate an auditor when we deem it necessary. Auditors are expected to adhere to the terms of the authorisation deed and conduct themselves professionally and impartially.
Further information about licensing and GMP is available on the APVMA website.
Adverse Experience Reporting Program
The APVMA operates the Adverse Experience Reporting Program. While this program has no formal compliance and enforcement function, it provides market intelligence that may focus our compliance and enforcement resources on areas of emerging concern.