• I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a primary step/s of manufacture

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  • Guideline for the transfer of a manufacturing site for immunobiological products

    The guideline supplements the tailored guidance material for manufacturing site transfer.

    This guideline aims to provide clarity and consistency on data requirements for manufacturing site transfers of primary and secondary manufacturing steps…

  • I want to vary the sites of product manufacture

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  • Guidance on veterinary drug joint reviews

    Joint review is the evaluation of a veterinary drug submission shared by two or more countries. Each regulator is assigned a technical section of the submission, and each review report is peer-reviewed by the other countries’ regulators. The aggregation…

  • Reconsidering approvals and registrations

    What is this guideline about? This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). The purpose of this

  • Limits on use of information

    What is this guideline about? This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). The purpose of this

  • Recategorising applications

    What is this guideline about? This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code). The…

  • Occupational health and safety (Part 6)

    This document sets out the recommendations and guidelines for submitting data in addition to the toxicological data recommended in Part 3 to enable the characterisation of the human health risks associated with the use of agricultural…

  • Pesticides: Overseas trade (Part 5B)

    Definition

    This guideline outlines the Australian Pesticides and Veterinary Medicines Authority's (APVMA) requirements for the submission of information and data relating to the impact on overseas trade of residues of agricultural and…

  • Occupational health and safety (Part 6)

    This document sets out recommendations and guidelines for submitting data in addition to the toxicological data recommended in Part 3 to enable the characterisation of the human health risks associated with the use of veterinary chemical…