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Veterinary Product Registration Guide

Below is a summary of the process for registering veterinary products with the APVMA.

  1. Does your veterinary product need to be registered with the APVMA?
    1. See the legal definitions and exemptions of veterinary products that the APVMA registers
    2. See 'Does your veterinary product require registration?' (PDF, 76kb) | (RTF 198kb) and Substances not permitted for use on food-producing animals in Australia
  2. Considerations before lodging your application
    1. See general requirements for lodging an application and an overview of the registration process
    2. Understand how to send confidential information to the APVMA via email (user guide) (PDF, 621kb)
  3. Understand the requirements for registering your product, including which category it fits into
    1. See the operational notices for veterinary products
    2. Work through the appropriate registration category of Vet MORAG
      1. Determine the data that you will need (if any) to submit to the APVMA to support your registration
      2. Review the guidelines for veterinary products to see if there are any special requirements for the type of product that you are registering
    3. Decide if you are submitting your application electronically (using EARS) (categories 7, 8, 10, 12, 13 and 14) or using MS Word forms (all categories - veterinary forms)
  4. Understand the labeling requirements for your product
    1. The role of a label, including the labeling code for veterinary products
    2. Label approval process for veterinary products
    3. Changes to existing labels
  5. Submitting your application
    1. If you completed your application using the MS Word forms, submit it to:
      The Screening Officer
      Australian Pesticides & Veterinary Medicines Authority
      PO Box 6182
      KINGSTON ACT 2604
    2. If you completed your application electronically via EARS, follow the instructions in EARS Manual to submit it.

Contact the veterinary product coordinator

Veterinary Products, Active Constituents and Permits

  • Applications for new products and variations to existing registered products
  • Application fees, registration requirements and guidelines
  • Approval of active constituents and chemistry requirements
  • Permits for off-label minor uses, research purposes or emergency situations

Phone: +61 2 6210 4789

Fax: +61 2 6210 4741

Email: vetmedicines@apvma.gov.au