I want to vary the pack size of my registered product

A registered chemical product can be varied via a number of different pathways. To vary the details for the net contents (a relevant particular: see regulation 16(db)) and the corresponding pack size, a variation can be made via the following application types:

  •  notifiable variation—NV
  •  non-technical fixed fee application—Item 12
  •  technical modular application—Item 14.

This information applies to both agricultural and veterinary chemical products unless otherwise stated.

Note: You can remove a pack size from your product range, and the e-label net contents statement, via any of the nominated pathways, as no technical data is required to remove a pack size.

The legislation

The Agvet Code sets out the requirements for varying the relevant particulars and conditions, of a registered chemical product (see Agvet Code, s 29). A variation to the pack size constitutes a change to the relevant particular—net content. A variation to the net contents will also involve a variation to the product label.

To determine any kind of variation the APVMA must be satisfied that the chemical product would still meet the safety criteria, the trade criteria and the efficacy criteria, if the relevant particulars were varied. For a variation to the net contents the APVMA must take into account any relevant particulars that would be entered in the register (see see s 5A(3)(a)(vi)). In considering a variation to the pack size the APVMA may have regard to the stability of the product (see see s 5A(3)(b)(iv)) and the specifications for the containers of the product (see sees s 5A(3)(b)(v)). The APVMA may also have regard to other 5A safety criteria where relevant such as where the exposure to human safety is impacted by the variation to the pack size.

The legislation allows some variations to be lodged as notifiable variations (see see s 26AA-AD). Notifiable variations are not an application, but you will be issued with a notification to confirm that the variation to the relevant particulars has been applied.

The Agvet code regulations (see regulation 19AE) sets out the types of changes that are permissible for notifiable variations. Note that the information in the regulations should be read in conjunction with the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016.

Selecting the appropriate pathway

When and how each of these pathways apply is detailed below. Please choose from the list for tailored guidance on the type of variation you wish to make.

Note: due to the differences in the generation for the e-label template, the pathways although often the same, are split between agricultural and veterinary chemical products.

Information on each pathway will appear at the bottom of this page, once you have made a selection. You can change your selection at any time.

Agricultural products

I want to vary the pack size for my agricultural product where the new pack size is:

Veterinary products

I want to vary the pack size for my veterinary product where the new pack size is:
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