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. Analysts

• Request to become or to change details for an APVMA Approved Analyst

4. 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

5. Auditors

• GMP audit report (FM_MQL05)
• Notification of completed audit form (FM_MQL06)
• Confirmation of audit booking form (FM_MQL23)
• Corrective action review—audit close-out form (FM_MQL24)
• Annex 1 Sterile products (FM_MQL27)
• Annex 2 Immunobiological and other products of biological origin (FM_MQL28)
• Annex 3 Non-sterile therapeutic products (FM_MQL29)
• Annex 4 Herbal products (FM_MQL30)
• Annex 5 Ectoparasiticides (FM_MQL31)
• Annex 6 Premixes supplements and biological feed additives(FM_MQL32)

6. Compliance

• Report suspected non-compliance

7. 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 (FM_CMAU43)
• Application for consent to import unregistered veterinary chemical products to be supplied and/or used under veterinary prescription (FM_CMAU44)
• Application for consent to import unapproved active constituents or unregistered agricultural or veterinary chemical products under miscellaneous circumstances (FM_CMAU45)

8. Fraud

• Fraud referral form

9. 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

10. Manufacturers declaration

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

11. Manufacturing licensing scheme

• Pre-audit notification and information form (FM_MQL04)
• Response to GMP audit report (FM_MQL26) – (audits conducted on, or after, 1 March 2016)
• Suspension of licence request (FM_MQL34)
• Request for a certificate of GMP compliance issued under the MRA (FM_MQL39)
• Cancellation of a licence request form (FM_MQL40)
• Manufacturers response to report of unannounced GMP audit (FM_MQL42)
• Pre-audit notification and information overseas (FM_MQL45)
• Regulation 62 notice – Changes to key personnel and GMP contacts 

12. Pre-application assistance

• Pre-application assistance (PAA) feedback form

13. Public consultation submissions

• Public submission coversheet

14. Recalls

• Notification to APVMA of voluntary recall

15. 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