I want to vary the sites of product manufacture

A registered chemical product can be varied via a number of different pathways. To vary the details for the sites of product manufacture a variation can be made by:

  • notifiable variation (agricultural products only) – NV
  • prescribed variation (veterinary chemical products only) – Item 13A
  • non-technical fixed fee application – Item 12
  • technical modular application – Item 14.

This information applies to both agricultural and veterinary chemical products (agvet) unless otherwise stated. This guidance does not contain information about varying the sites of manufacture for active constituents.

The legislation

The Agvet Code sets out the requirements for varying the relevant particulars and conditions, of a registered chemical product (Agvet Code, s 29). A variation to the site of product manufacture (such as the addition of a site, the change of the name of a site, or removal of a site) constitutes a change to the relevant particulars. Where the change to the site involves an overseas site of manufacture for a veterinary product there may also be a variation to the conditions.

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 site of manufacture the APVMA must take into account how the product is formulated (see s 5A(3)(a)(iii)), and the conditions to which the registration is subject to (see s 5A(3)(a)(v)) in relation to manufacturing.

The legislation allows some variations to be lodged as either notifiable variations (see s 26AA-AD) or as prescribed variations (see s 26A-D).

Agvet Code Regulations sets out the types of changes that are permissible for notifiable (see regulation 19AE) and prescribed variations (see regulation 19AF). 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 following for tailored guidance on the type of variation you wish to make.

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.

OR

I want to vary the site of manufacture for my veterinary product and the variation involves:

Note:

Some veterinary chemical products, such as immunobiological veterinary chemical products and antibiotics which are pure active constituent products, have special Good Manufacturing Practice (GMP) requirements and may require a more tailored assessment approach. You should use the decision tree to determine the pathway for these application types. You may also wish to consult the veterinary data guidelines for more specific information, prior to submitting your application.

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