This content is current only at the time of printing. This document was printed on 19 June 2018. A current copy is located at https://apvma.gov.au/node/65
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After you apply
After receiving an application for a licence to manufacture veterinary chemical products in Australia, the APVMA notifies the applicant within ten days.
Assessing an application
Applications for licences are assessed in accordance with the Agvet Code.
Before an application will be accepted, it must be:
- in writing on the approved form
- accompanied by the relevant fee
- accompanied by any information that is specified in the legislative instrument.
Providing further information
If the APVMA requires further clarification of the information submitted for a manufacturing licence, it will issue a notice under section 122(2) of the Agvet Code.
Applicants must provide the information requested within the timeframe stated in the notice.
Refusing a licence application
Circumstances that may lead to the APVMA refusing an application may include:
- an applicant failing to meet the application requirements
- failure by the applicant to respond to our requests for further information
- failure by the applicant to provide the report of the audit to the APVMA
- failure by the applicant to demonstrate to APVMA satisfaction:
- failure by the applicant to pay the prescribed fee
- the APVMA finding that the applicant is not a ‘fit and proper person’.
Appealing a decision
Section 167 of the Agvet Code lists a range of decisions we make relating to applications for manufacturing licences that can be reviewed by the Administrative Appeal Tribunal (AAT). You can also seek internal review of any decision listed at section 167. Manufacturing licensing decisions eligible for AAT review—or internal review—include:
- refusal of an application to issue a licence because an applicant has not met certain application requirements (see below)
- issuance of a licence subject to certain conditions
- imposition of new conditions on a licence or variation of existing conditions
- suspension and cancellation of a licence.
Where an application for review is made, we will reconsider our original decision. A person other than the person who made the original decision will confirm it, vary it or set it aside and make a new decision.
AAT review is not available for decisions made by us to refuse your application for a manufacturing licence, where our decision was based only on the application requirements not being met under section 122(1) of the Agvet Code.
Application requirements set out under section 122(1) of the Agvet Code must:
- be in writing in the approved form
- be signed by you
- be accompanied by so much of the prescribed fee as is required to be paid when your application is made
- be lodged with the APVMA
- contain or be accompanied by any information specified for the application in the legislative instrument created by us under section 8B of the Agvet Code.
Internal review is still available for these decisions.
Withdrawal of an application
Applicants may withdraw their application should they decide to not proceed.
Requests to withdraw can be submitted to the APVMA in writing via email or post. This may occur before or after an audit has taken place.
Issuing a licence
The APVMA must issue a licence in the circumstances specified in section 123 of the Agvet Code.
To issue a licence, the APVMA must be satisfied:
- the applicant passes the fit and proper person test and has not been convicted of a relevant offense
- the applicant will be able to comply with the conditions to be imposed on the licence if the licence is issued
- the site is satisfactory for the manufacture of the nominatedproducts
- the applicant can comply with the Manufacturing Principles and GMP Code.
Annual fees are payable for licences.
Those issued with a licence have certain ongoing responsibilities under the Agvet Code. This includes maintaining compliance with the Manufacturing Principles and GMP Code, undergoing regular GMP audits, paying the appropriate annual licence fee and complying with any conditions specified on their licence.
Suspension and cancellation of licences
Manufacturing licence holders need to comply with the conditions of their licences. Non-compliance can lead to the suspension or cancellation of licences. A licence can be suspended or cancelled if the holder:
- fails to comply with the Manufacturing Principles
- contravenes the licence conditions
- is or has been convicted of an offence against an agvet law, another law relating to criminal products, or certain criminal laws (is declared to not be a ‘fit and proper person’ to hold a licence)
- fails to pay a prescribed fee
- ceases to carry out the manufacture to which the licence relates
- requests that the licence be suspended or cancelled.
The APVMA can suspend or cancel a licence without notice if failure to do so would immediately result in imminent risk:
- of death, serious injury or serious illness to people
- of unintended harm to animals, plants or things or to the environment or
- of impact on trade or commerce between Australia and places outside Australia.
We can also add to or vary the conditions of a licence to prevent such risks occurring.