Caltrop Controlla Case
Response to written assessment task:
1.Do you think the application for Caltrop Controlla would comply with the APVMA Labelling Codes? Please explain why it would or would not.
According to the best practice guide of the APVMA Labelling Codes, a product name should be distinctive. It must not be misleading or confusing with other registered product names. Where the product name is not distinctive, the company name could be incorporated into the product name to distinguish it from other products having similar names. However, the name of the new product Caltrop Controlla that has applied for APVMA registration is very similar to an already registered product called Caltrop Controller. Because of this name, the new product could lead to unfair …show more content…
In addition, under Section 162 of the Agvet Code, clear restrictions were placed on the direct and the indirect disclosure of confidential commercial information by the APVMA. Hence, in this case, there is no evidence for APVMA to assess the risks associated with the efficacy and safety posed by Caltrop Controlla. Furthermore, based on the information provided, it is also not possible to assess that the label instructions of the reference product would be suitable to manage the risks posed by Caltrop …show more content…
Most of the users of those products are unlikely to have experience dealing with hazardous chemicals and personal protective equipment. Therefore, the home garden product should not require any precaution or personal protective equipment for preparation and use or disposal of the product and its container. The product Caltrop Controlla Plus, as determined by the toxicology and work health and safety evaluations, requires the users to wear a full faced respirator and therefore, it will not be suitable for home garden products.
b. Caltrop Controlla Plus is also proposed for use on grass pastures for the control of caltrop at the same equivalent application rate of active constituent. This is the first use outside home gardens for a product containing herbicidium. How has the risk profile of this product changed compared to home garden products containing herbicidium? Please provide your response based on the statutory criteria of the Schedule to the Agricultural and Veterinary Chemicals Code Act
1.Do you think the application for Caltrop Controlla would comply with the APVMA Labelling Codes? Please explain why it would or would not.
According to the best practice guide of the APVMA Labelling Codes, a product name should be distinctive. It must not be misleading or confusing with other registered product names. Where the product name is not distinctive, the company name could be incorporated into the product name to distinguish it from other products having similar names. However, the name of the new product Caltrop Controlla that has applied for APVMA registration is very similar to an already registered product called Caltrop Controller. Because of this name, the new product could lead to unfair …show more content…
In addition, under Section 162 of the Agvet Code, clear restrictions were placed on the direct and the indirect disclosure of confidential commercial information by the APVMA. Hence, in this case, there is no evidence for APVMA to assess the risks associated with the efficacy and safety posed by Caltrop Controlla. Furthermore, based on the information provided, it is also not possible to assess that the label instructions of the reference product would be suitable to manage the risks posed by Caltrop …show more content…
Most of the users of those products are unlikely to have experience dealing with hazardous chemicals and personal protective equipment. Therefore, the home garden product should not require any precaution or personal protective equipment for preparation and use or disposal of the product and its container. The product Caltrop Controlla Plus, as determined by the toxicology and work health and safety evaluations, requires the users to wear a full faced respirator and therefore, it will not be suitable for home garden products.
b. Caltrop Controlla Plus is also proposed for use on grass pastures for the control of caltrop at the same equivalent application rate of active constituent. This is the first use outside home gardens for a product containing herbicidium. How has the risk profile of this product changed compared to home garden products containing herbicidium? Please provide your response based on the statutory criteria of the Schedule to the Agricultural and Veterinary Chemicals Code Act