Veterinary Manual of Requirements and Guidelines - Vet MORAG

Vet MORAG provides information on data requirements and guidelines for applications to register or
approve veterinary chemical products, labels, active constituents and issue permits

Summary of changes
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Volume 1
Background

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Volume 1 sets out the legal background to the to the National Registration Scheme. Volume 1 also gives information on how to make an application to the APVMA and the how the APVMA manages the registration process.

General

  • Introduction to MORAG MORAG is the APVMA's Manual of Requirements and Guidelines.
  • Application procedures Under the Agricultural and Veterinary Chemicals Code Act 1994 (available here) the Australian Government, through the APVMA, regulates the manufacture, supply and sale of agricultural and veterinary (agvet) chemical products in Australia.

Legal

  • Legal background The majority of primary producers rely on the supply of pesticides and veterinary medicines to protect their crops and livestock from pests and disease.
  • Legislative instrument 1 This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005.
  • Legislative instrument 2 This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005.

Volume 2
Application categories

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Volume 2 describes the 25 different application categories so that applicants can select the correct application category for their application.

General

Product registration

  • Category 1 Approval of a new active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label.
  • Category 2 Approval of a new active constituent and registration of an associated chemical product: Modular assessment.
  • Category 3 Registration of a new chemical product with an approved active constituent where no registered chemical product contains the active constituent.
  • Category 4 Registration of a new chemical product with an approved active constituent, for use on a major food crop.
  • Category 5 Registration of a new chemical product which is similar to a registered chemical product.
  • Category 6 Registration of a new chemical product that is closely similar to a registered chemical product: Chemistry and manufacture data required.
  • Category 7 Registration of a new chemical product that is closely similar to a registered chemical product: Chemistry and manufacture data not required.
  • Category 8 Repack of a registered chemical product.
  • Category 9 Listed registration of a chemical product.
  • Category 10 Registration of a new chemical product: Modular assessment.

Variation

  • Category 11 Extension of use to include a new major food crop.
  • Category 12 Minor, non-technical variation to label and/or product details.
  • Category 13 Minor, non-technical variation to label and/or product details, required by the APVMA.
  • Category 14 Variation to a registered chemical product or approved label: Modular assessment.

Active constituent

  • Category 15 Approval of a new active constituent: Comprehensive assessment.
  • Category 16 Approval of a new active constituent: Limited toxicology assessment.
  • Category 17 Approval of a new active constituent: Toxicology assessment not required.
  • Category 18 Variation to particulars or conditions of an approved active constituent.

Permit

  • Category 19 Application for a permit to possess or supply for export an unapproved active constituent or unregistered chemical product.
  • Category 20 Application for a permit where a previous assessment remains valid and no data of a technical nature are required.
  • Category 21 Application for a minor use permit.
  • Category 22 Application for an emergency use permit.
  • Category 23 Application for a research permit or application for other permit type.

Other applications

  • Category 24 Registration of a chemical product or approval of an active constituent requiring technical assessment and not covered by Categories 1-8, 10, or 15-17.
  • Category 25 Assessment of a trial protocol or application requiring technical assessment and not covered by any other category.

Volume 3
Data

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Volume 3 gives details of the requirements and guidelines for each of the 10 data parts which might apply to different types of applications.

Outline

Data parts

Volume 4
Guidelines

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Volume 4 sets out guidelines for applications to register specific types of products.

APVMA Information sheets outline key processes including registering agricultural and veterinary medicine products.

WAAVP guidelines have been developed by the World Association for the Advancement of Veterinary Parasitology (WAAVP). They are available by telephoning the Vet Contact Officer on (02) 6210 4726.

VICH guidelines listed are endorsed by the APVMA. They have been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - a cooperative programme between the European Union, USA, and Japan. Australia and New Zealand have observer status on the VICH Steering Committee.

Anthelmintics

Bioequivalence/Bioavailability

  • Demonstrating Bioequivalence and Bioavailability APVMA GL13

Chemistry

Ecotoxicity

Ectoparasiticides

  • Companion Animal: cats, dogs, ornamental caged birds APVMA GL16
  • Companion Animal: small animal APVMA GL17
  • Food Producing Animal: Buffalo fly APVMA GL19
  • Food Producing Animal: Cattle tick APVMA GL20
  • Food Producing Animal: Flystrike preventatives and treatments APVMA GL21
  • Food Producing Animal: Ovine footrot - non-benign APVMA GL18
  • Food Producing Animal: Ovine lousicides APVMA GL23
  • Food Producing Animal: Ovine miticides APVMA GL22

Feeds/Supplements

  • Direct Fed Microbial Products APVMA GL9
  • Enzyme Based Products APVMA GL10
  • Stock Foods and Stock Food Additives APVMA GL7
  • Stockfeed Supplement Products (Containing only ‘Nutritional Messages’) APVMA GL8
  • Therapeutic Pet Food APVMA GL11

Immunobiologicals

Impurities

Intramammaries

Safety

Stability

General

Residue

Volume 5
Labeling

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Volume 5 contains the vet Labelling Code which sets out requirements and best practice for product labels. Volume 5 also describes how the APVMA approves labels which will be attached to registered products.