the registration process - How to prepare an application

• Submit your application electronically. Read the guidance for electronic registration.

Submitting and application

The Manual of Requirements and Guidelines sets out the process for registering agricultural and veterinary products. To learn how MORAG works and for guidance on submitting a registration application for chemical products, active constituents and product labels start by reading the Introduction to Ag MORAG and Introduction to Vet MORAG.

An application to register an agricultural or veterinary chemical product should be submitted, using the relevant application form, only after a complete data package has been assembled.

All applications should be accompanied by the relevant application fee. In addition, a draft label that adheres to the APVMA's current code of practice for labelling agricultural and veterinary chemical products must also be submitted for approval before a product can be registered.

For more information about applications contact Registration Enquiries.

Data requirements

Data requirements for registering products are described in Volume 3 of Ag MORAG and Vet MORAG. You can read more about data requirements and data protection on this site.

Active constituents

The approval process for active constituents is described in Volume 2 of Ag MORAG and Vet MORAG. You can read more about active constituents and standards on this site.

Labels

The label approval process is described in Volume 5 of Ag MORAG and Vet MORAG. Electronic submission for final label approval is now available. Read about e-label submission and other changes to the label approval process.

Assessment

Assessment of applications is described in 'Module levels for modular categories' in Volume 3 of Ag MORAG and Vet MORAG. Many efficacy and safety assessments are outsourced to State department and external reviewers. The APVMA relies on these reviewers to provide it with a scientific assessment of the data presented with an application, and to make informed recommendations regarding the efficacy and safety of a product. Reviewers rely on the Manual for Efficacy and Safety Reviewers to assist them in making their assessments and recommendations. Whenever a new chemical or new active constituent is being considered for registration, or registration is being amended to allow a major change of use, the APVMA places a notice in the APVMA Gazette.

Public consultation

Before a chemical product based on a new active constituent is registered, the APVMA publishes a Public Release Summary of an evaluation and makes it available for public comment where relevant.  This includes a discussion on possible effects on trade.  Where an existing, currently registered product's use is to be extended to a new food crop or animal, the APVMA publishes a trade advice note that specifically addresses possible effects on trade.Trade Advice Notices are advertised in the APVMA gazette. Overseas trade aspects of residues in food commodities and other trade issues are detailed in Ag MORAG and Vet MORAG. A period of public consultation follows each type of notice, during which time members of the public and relevant industry bodies have an opportunity to raise matters of concern about human, animal and environmental safety; efficacy; and trade. These comments are considered before a final decision is made to register a product.

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