Introduction to MORAG
1. WHAT IS MORAG?
MORAG is the APVMA’s Manual of Requirements and Guidelines. With regard to agricultural and veterinary (agvet) chemicals to be manufactured or used in Australia , it sets out the Australian Government’s requirements for:
- approval of an active constituent
- registration of a product
- approval of a label
- variation to an active constituent, product or label.
MORAG is published in two versions:
- Ag MORAG
- Vet MORAG.
Each version contains information directly relevant to either agricultural or veterinary chemicals. However, the general principles of each version are identical and approximately 90 per cent of the text is identical in each version.
MORAG replaces the Ag and Vet Requirements Series which have become redundant subsequent to amendments to Schedules 6 and 7 of the Agvet Code Regulations, which came into force on 1 July 2005.
Each version of MORAG is divided into five volumes as shown in Table 1.
MORAG aims to clearly show what is a requirement and what is a guideline when making an application to the APVMA for approval of an active constituent, registration of a product, approval of a label, or a variation to an active constituent, product or label.
2. HOW IS MORAG USED?
An applicant can work through the five volumes of MORAG to find the answer to the questions:
- why does my product require registration?
- how do I make an application for registration?
- under which application category should the application be made?
- what data are required?
- what will be the cost and timeframe for evaluation?
- what instructions and warnings should appear on the label?
Volumes 2 and 3 are closely linked: Volume 2 shows the category under which an application should be made, and Volumes 2 and 3 both give information on data requirements for an application.
Figure 1 is a map of MORAG which shows how all MORAG volumes work together.
MORAG is located on the APVMA website, from where it can be printed and placed into binders. It will be continuously under review. When a chapter is changed, the APVMA will publish a notification on the APVMA website and notify subscribers to the APVMA’s email list.
The APVMA welcomes comment and suggestions for revision of MORAG. Comments and suggestions should be sent to the APVMA at MORAG_feedback@apvma.gov.au
| Volume title | Contents | Replaces… |
|---|---|---|
| Volume 1 Legislation and applications |
Introduction to MORAG Legal background to the National Registration Scheme Procedures for making applications Legislative Instruments |
Module A of the Ag and Vet Manuals |
| Volume 2 Category requirements and guidelines |
How to use Volume 2 1. Application for approval of a new active constituent 2. Application for approval of a new active constituent 3–10. Application for registration of a product containing 11–14. Application to vary a product or label 15–17. Application for approval of an active constituent 18. Application for variation to an active constituent 19–23. Application for permit 24–25. Other applications |
Ag and Vet Manuals Permit guidelines |
| Volume 3 Data requirements and guidelines |
Module levels for modular categories Data requirements and guidelines Parts 1 to 10 |
Ag and Vet Requirements Parts 1 to 10 |
| Volume 4 Specific product guidelines |
Specific product guidelines on the APVMA website | |
| Volume 5 Labelling |
Ag and Vet Labelling Codes | Ag and Vet Labelling Codes |
Figure 1. MORAG map
Click the image below to view a larger version of the MORAG map
