Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Volume 4 - Guidelines

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

Pharmaceuticals

Chemistry (Part 2)

Human Safety (Toxicology - Part 3)

Residues (Part 5)

The APVMA has temporarily removed the Veterinary Residues Guidelines from the Veterinary Manual of Requirements and Guidelines (Vet MORAG) to allow them to be updated to reflect the current requirements of the APVMA.

The guidelines were written before July 2006 when the APVMA adopted the JECFA approach to setting Maximum Residue Limits (MRLs), and required the setting of Export Slaughter Intervals (ESIs) for new products and extensions of use.

The APVMA has described the data requirements for these areas in Vet MORAG Parts 5A (Residues) and 5B (Trade). Applicants are invited to consult these parts of Vet MORAG for information or consult the APVMA at:

APVMAResidues@apvma.gov.au or
Phone +61 2 6210 4837 or
Fax +61 2 6210 4840.

Environmental Safety (Part 7)

Target Animal Efficacy and Safety (Part 8)

Anthelmintics

Coccidiostats

Ectoparasiticides

Antibiotics - Intramammaries

Teat Dips and Sprays

Generic Products

  • Demonstrating Bioequivalence and Bioavailability APVMA GL13

Immunobiologicals

Complementary Animal Health Products

Registration Models for Products with Reduced Data Requirements

  • Oral electrolytes for horses in exercise APVMA GL71

Miscellaneous

Further information