This content is current only at the time of printing. This document was printed on 18 September 2020. A current copy is located at http://www.xlg888.com/node/1112
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Who can apply
An APVMA manufacturers' licence is required by anyone engaged in any step of manufacture of a veterinary chemical product in Australia, unless specifically exempt.
Only Australian manufacturing sites can apply for a veterinary chemical product manufacturing licence.
Individuals or body corporates can apply for a licence to manufacture veterinary chemical products in Australia, as can an authorised agent representing them. However, anyone applying for a licence needs to pass the fit and proper person test and have not been convicted of a relevant offence.
The APVMA issues licences only to sites that have demonstrated compliance with the APVMA’s Manufacturing Principles and the Australian Code of GMP for Veterinary Chemical Products. Sites are audited to confirm that they comply with these requirements before a licence is issued and at regular intervals while the licence is in force.
1. Manufacturers in Australia
Steps of manufacture can include:
- quality assurance (QA) of raw materials and/or packaging materials
- formulation and blending
- storage associated with the manufacturing process
- sterilising and microbiological reduction
- analysis and testing
- release from manufacture and/or release for supply or sale.
Section 121(4) of the Agvet Code provides more details on who needs to apply.
2. Authorised agents
Applicants may appoint an authorised agent, such as a registration consultant, to act on their behalf during the licence application process. This means the agent is the person completing the application and liaising directly with the APVMA.
Authorised agents have certain responsibilities in their interactions with the APVMA. For example, the responsibility under the Agvet Code to not provide false or misleading information. However, an authorised agent does not have the same obligations as a nominated agent would.
An authorised agent may be appointed for a specific period or a specific task for holders who reside in Australia or are registered to conduct business in Australia. The appointment ceases on completion of the timeframe or task or if the appointment is terminated. In other cases the appointment ceases when the application is finalised or if it is withdrawn prior to finalisation.
3. Fit and proper persons
The Agvet Code includes a ‘fit and proper person’ test which must be met before the APVMA can issue a manufacturing licence. This means only those considered ‘fit and proper persons’ should apply for a licence.
Under these arrangements, the APVMA must refuse an application if the proposed applicant or persons with a specified relationship with the proposed?applicant has:
- been convicted of an offence against an agvet law
- been convicted of an offence against a law of this or another jurisdiction relating to chemical products
- been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty
- been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision
- been ordered to pay a pecuniary penalty for the contravention of another law of this or another jurisdiction relating to chemical products
- been ordered to pay a pecuniary penalty for the contravention of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty
- been a manager, or a major interest holder, of a body corporate who was convicted of an offence or been ordered to pay a pecuniary penalty of the type listed above while that person was a manger or majority interest holder of the body corporate
- for a permit application, held a permit that was cancelled under subsection 119(2) or section 119B of the code or under a corresponding provision of the Agvet Code of another jurisdiction
- for a licence application, held a licence that was cancelled under subsection 127(1)(d) or (e) of the code or under a corresponding provision of the Agvet Code of another jurisdiction
- been a manager, or a major interest holder, of a body corporate that held a permit/licence that was cancelled in the circumstances set out above, while that person was a manager or majority interest holder of the body corporate
- for a licence application, has within the 5 years immediately before the application failed to comply with a manufacturing principle in connection with the manufacture of chemical products.
3.1. Relevant offences
A person convicted of a relevant offence cannot be issued with a manufacturing licence.
This can include persons who have been convicted of an offence or been ordered to pay a pecuniary penalty for contravention of:
- an agvet law
- a law of this or another jurisdiction relating to chemical products
- a law of the Commonwealth or of a state or territory involving fraud or dishonesty.
An applicant may have been convicted of an offence for present purposes even if:
- a court has decided not to record a conviction
- the relevant person was a manager or major interest holder of a body corporate which was convicted of a relevant offence.
Despite this prohibition, the APVMA may issue a licence if, in its opinion, special circumstances make it appropriate to do so. The APVMA will determine the criteria for what constitutes a special circumstance on a case-by-case basis.
The criteria will depend on the specific facts relating to the offence or contravention, as well as any remedial actions undertaken. For example, the APVMA may consider exercising the special circumstance provision in a situation where an employee of the applicant has committed the relevant offence without the applicant’s knowledge or in situations where the applicant provides suitable evidence of how that employee’s conduct has been managed to prevent similar contraventions occurring in the future.