A timeshift application provides for the staged submission of supporting data packages allowing the commencement of longer assessments (such as health, poisons scheduling and environment) while other supporting data packages (such as efficacy and crop safety) are being completed.
Timeshift applications can be used for applications involving multiple assessment modules including:
- approval of a new active constituent
- registration of a product that contains a new active constituent
- registration of a product that contains an approved active constituent or variation of a registered product where two or more technical assessment modules (modules 2 to 10 of the module types) apply
- where there is a previously approved active constituent not in any currently registered products
- global joint reviews (GJRs)
- to facilitate the use of overseas assessments.
The application is assessed according to a project plan which is developed and agreed between the applicant and the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3. A timeshift application cannot be submitted without an agreed project plan.
The agreed project plan sets out the sequence for the submission of each data package (chemistry and manufacture, health, residues, environment, efficacy, crop safety, trade – including non-food and any special data if required) and the timeframe for conducting the necessary modular assessments.