Time required to register a product, avoiding delays

Registration may take up to 18 months (or more if there are major deficiencies in applications) to complete in the case of new products with new active constituents. This allows time for screening of an application, consultation (when necessary) and hands-on evaluation of the data submitted.

Registration of variations to products already on the market are completed more quickly because fewer data have to be submitted and evaluated.

There are two stages in the registration process:

1. Screening. Screening occurs before an application is formally accepted for evaluation to ensure that it is complete and correctly prepared. Any obvious deficiencies in the data submitted are identified and applicants are advised of them. Applicants are also advised of the number of copies of data to be submitted.

2. Evaluation. Evaluation begins when a complete application, all the necessary copies of data and the relevant fee are submitted. Legislated timeframes for evaluation range from 3 to 15 months.

The time taken to evaluate an application is clocked by a computerised tracking system which is 'turned on' when an application has been formally accepted for evaluation.

If it becomes apparent during an evaluation that further data are required to substantiate claims related to safety, efficacy or other requirements, the applicant is advised immediately. At this point, the evaluation is placed 'on hold' and the clock will be stopped. The clock is restarted when the required data are provided.

Avoiding delays in registration

At any time 50 per cent or more of all applications are back with the applicant to supply further required information.

The main causes of delay are:

• inadequate covering letters;

• insufficient data being supplied initially;

• labels not being prepared according to the relevant labelling code; and

• applications being submitted without necessary letters of support (for active constituents sources and repacks).

To avoid unnecessary delays, applicants should carefully read the appropriate APVMA manuals and guidelines before submitting an application. If, after reading these publications, the requirements are still not clear, they should contact the APVMA for assistance.