This content is current only at the time of printing. This document was printed on 12 September 2020. A current copy is located at http://www.xlg888.com/node/43
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Getting assistance from the APVMA
The APVMA offers a range of assistance and guidance:
- general assistance
- technical advice
- technical assessment.
This is the first level of support we provide and includes clarification of general administrative requirements, how to find information on our website and about our online application system.
For more information and to contact the APVMA for general assistance.
Technical advice—pre-application assistance
The APVMA offers technical advice to applicants on a fee-for service basis, known as pre-application assistance.
Pre-application assistance gives applicants the opportunity to reduce the uncertainty associated with a specific prospective application. It is offered on a fee-for-service basis and can take the form of a written response, a face-to-face meeting or a teleconference.
Pre-application assistance can be used for any type of application and can include advice about:
- administrative requirements
- types of information required to address statutory criteria
- the relevance of the efficacy or trade criteria
- timeframes and fees
- the use of overseas data and/or assessments
- suitability of a trial protocol
- project plans for time shift applications and agreements for global joint review applications.
Pre-application assistance has been divided into three tiers so the fees we charge directly relate to the complexity and effort required.
- is designed to support the early stages of preparing an application such as guidance and clarification on the types of assessments necessary for the proposed application.
- can be used for technical advice to support a particular application and is designed to give applicants greater confidence that their proposed submission will contain relevant information to address the safety, efficacy or trade criteria.
- advice can include appraisal of specific study design and finalisation of project plans for Global Joint Reviews.
Technical Assessment (Item 25)
Technical assessment?is reserved for determining that a data package addresses the safety, efficacy or trade criteria. An outcome of a technical assessment can be used by an applicant as part of a future application.
The fees and timeframes for a technical assessment are modular—which means the modules selected are based on the type and level of assessment. Under an Item 25 application the APVMA will conduct a full technical assessment of a data submission. This may include assessments of data that are intended to be relied on to support a future application, including overseas data to determine its relevance to the safety, efficacy or trade criteria.?In addition to the modules required for the type and level of assessment, a finalisation module 11.3 is required for all item 25 applications.