- Print Friendly - Help

AgVetLink April 2003

Previous page  | Contents |  Next page

---

Identification of specific regulatory statements on labels

The ACVM Group has had discussions with a number of parties about identifying regulatory statements on labels. Under the Animal Remedies and Pesticides Acts the ACVM Group approved final labels and did not explicitly provide for off-label use. However, under the ACVM Act, only the label content relevant to the ACVM Act is approved rather than the whole final label. In addition, there is now a specific condition that allows for off-label use, if such use is acceptable.

There will be occasions when a registrant may want to make statements on a label that have nothing to do with the conditions of registration of the product. If the ACVM Group considers that inclusion of such statements on the label does not jeopardise regulatory control, then it will allow the statements.

To a user of products, such statements on labels may look like regulatory statements imposed under the ACVM Act. Concern has been expressed to the ACVM Group that allowing registrants to make use statements in addition to those approved makes it difficult for a user to distinguish between a direction from a registrant, an ACVM-approved statement and a regulatory statement.

To clarify the distinction between regulatory statements and statements made by the registrant, the ACVM Group has developed a set of labelling principles:

• The current registration approval must expressly state all the conditions that have been imposed.
• Any condition that has a regulatory impact on the users of products must be stated as a regulatory statement in the label content.
• Each regulatory statement must be recognisable for what it is by its wording at least.
• The ACVM Group will allow registrants to make statements on the label only if the statements do not jeopardise regulatory control.
• Regulatory statements must be made explicit by requiring any one of the following:
  1. it is a condition on the registration that…;
  2. it is an offence under the ACVM Act (or ACVM Regulations) to…;
  3. failure to… may be an offence under the ACVM Act (or ACVM Regulations);
  4. by law….

These are only examples. There may be other phrases acceptable to the ACVM Group that make the regulatory statements equally explicit.

From now on the ACVM Group will be specific about the regulatory statements that must be included on the labels of products. For new registrations the Group will discuss with registrants the statements that must be included on the labels. For existing registrations the label changes will be discussed as part of the registration updating process. For products that have already been updated the changes will be introduced in a timeframe agreed to with the affected registrants.

The inclusion of all the regulatory statements into a 'regulatory box' was suggested as a possible option to identify such statements clearly. It appears that, over time, a regulatory box may become the preferred way for registrants to meet the ACVM labelling requirements. However, initially at least, the position and form of the statements will not be prescriptive but the specific wording will be part of the label content approval.

Label content on website

In February 2003 the ACVM Group commenced publishing the label content of products on the public register.

It should be noted that label content is published only for products that have been registered under the ACVM Act or have had new (updated) registrations issued under that Act. Not all products have label content available as yet.

To view the label content of a product, go to the ACVM website and click on the 'Registers and Lists' link. Search for and select the required product, then click on the 'Label Content' link. There could be more than one link available depending on the related components.

There may be only one pack size for a product label appearing on the register; however, other sizes may have also been approved for that product.

If you have any comments or concerns with this new facility, please contact an Advisor (Operations).