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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…
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- 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…
- 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
- 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
- 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…
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…
- 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…