Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Category 1 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 1 application as:

Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring a full assessment of the active constituent and chemical product.

1.1.   Veterinary applications are not assessed under Category 1

Module 6.1 in Module levels for modular categories in Volume 3 states that applications for registration of a new veterinary active constituent and associated product will not require a full1 (comprehensive) assessment of OHS data.

For this reason, applications for approval of a new active constituent and registration of a new veterinary product containing the new active constituent will be assessed under Category 2.

FOOTNOTES

  1. A full product assessment for Category 1 is equivalent to the following modules in Schedule 7 to the Agvet Code Regulations: Modules 1, 2.1, 3.1, 4, 5.1, 6.1, 7.1, 8.1, 11.1 and 12.

REVISION HISTORY

Revision Date Description of Revision
1 July 2005 First edition
1 October 2005

Second edition

  • no changes.

1 April 2006

Third edition

  • no changes.

1 July 2007

Fourth edition

  • minor text changes.