Forms

1. APVMA Online Services Portal

• APVMA online system new user access form
• Changes to company details
• Changes to company contact details

2. Adverse Experience Reporting Program

• Periodic Summary Updates Report (PSUR) template – to be used by holders to provide the APVMA with an annual summary of adverse experiences.

Information on how to report an adverse experience is available on our website.

3. Applications

• Application for a licence to manufacture veterinary chemical products
• Application for a permit where the use of the chemical product or active constituent is proposed to be an emergency use
• Application to vary a licence to manufacture a veterinary chemical product

4. Auditors

• GMP audit report
• Notification of completed audit form
• Confirmation of audit booking form
• Corrective action review – audit close-out form
• Annex 1 Sterile products
• Annex 2 Immunobiological and other products of biological origin
• Annex 3 Non-sterile therapeutic products
• Annex 4 Herbal products
• Annex 5 Ectoparasiticides
• Annex 6 Premixes supplements and biological feed additives

5. Compliance

• Report suspected non-compliance

6. Consent to import

• Consent to import unapproved active constituents or unregistered agriculture and veterinary chemical products to be supplied and/or used in accordance with an APVMA permit
• Application for consent to import unregistered veterinary chemical products to be supplied and/or used under veterinary prescription
• Application for consent to import unapproved active constituents or unregistered agricultural or veterinary chemical products under miscellaneous circumstances

7. Fraud

• Fraud referral form

8. Hormonal growth promotants

• Change of contact details for a supplier of hormonal growth promotants
• HGP purchaser declaration form
• HGP monthly return form (electronic)
• Notification of intention to supply HGPs

9. Manufacturers declaration

• Manufacturers declaration template – from manufacturer
• Manufacturers declaration template – from reference product holder
• Manufacturers declaration template – pesticide and veterinary examples

10. Manufacturing licensing scheme

• Pre-audit notification and information form
• Response to GMP audit report
• Suspension of licence request
• Request for a certificate of GMP compliance issued under the MRA
• Cancellation of a licence request form
• Manufacturers response to report of unannounced GMP audit
• Pre-audit notification and information overseas
• Regulation 62 notice – Changes to key personnel and GMP contacts
• Steps of Manufacture

11. Pre-application assistance

• Pre-application assistance (PAA) feedback form

12. Public consultation submissions

• Public submission coversheet

13. Recalls

• Notification to APVMA of voluntary recall

14. Suspension or cancellation of approval or registration at the request of holder

• Cancellation of approval or registration at the request of holder
• Suspension of approval or registration at the request of holder