7 March 2003
Changes to the Approvals Secretariat Sift and Administrative Fast Applications
The purpose of this letter is to inform all applicants of changes to the function of the Approvals Secretariat Branch sift, and modifications to the criteria for administrative fast stream applications.
Background
Many of you will be aware that the Approvals Secretariat Branch holds a weekly ‘sift’ of submitted applications. At this sift we determine the acceptability of an application, allocate each application to a particular stream and calculate the fee to be charged. The sift currently results in either acceptance (i.e. the information included in the application is sufficiently complete to allow evaluation) or rejection (where the application is judged incomplete, and the applicant informed via a ‘reject letter’ of the information required for acceptance). Both result in a fee of £125 to the applicant. This fee covers both the administrative actions (filing, invoicing etc.) and an initial technical examination (checking data access issues, completeness of application form and charging/streaming decisions).
Changes to the Sift
PSD will shortly be changing the role of the sift. Instead of a ‘completeness check’ we will instead conduct a simple ‘filter’, allowing for the streaming and charging of the application. All applications that pass through this initial filter, will be accepted, streamed and invoiced accordingly. Applications will no longer be rejected for incorrectly completed application forms, lack of labels, incorrect data access letters etc. A charge of £125 will be applied to the sift process to cover the elements that remain (filing, streaming, charging etc.)
The onus will remain with the applicant to ensure that an application is complete since failure to do so may require additional clarification during the evaluation. This may delay completion of the application and in some cases could result in refusal of approval.
To help you produce complete applications, PSD have produced a number of checklists to be used in addition to the current application guidelines.
Changes to Administrative Fast Applications
Administrative fast (admin fast) applications are those for which there is no technical assessment. Historically, we have tried to consider as many different types of applications as possible via this route. This often resulted in some element of technical assessment at the sift stage.
In order to allow full cost recovery within the administrative fast fee modules, we need to ensure that the work conducted is administrative rather than technical. This means that it will no longer be possible to assess such a wide variety of applications by this route.
New criteria for admin fast applications are given in the application handbook. You will note many of the key types of admin fast application remain, such as approval for identical (back to back) products, approval for changes to similar products and company name changes/mergers.
Applications for formulation changes (including changes of source), label changes (including the addition of tank mixes), reinstatement of approvals following previous revocation, and all but the simplest of packaging changes, require technical assessment and will now be considered via the fast stream.
Implementation Date
The first sift to incorporate these changes will be held on Tuesday 1 April 2003. From this point forward, there will be a reduced level of technical consideration at the sift, and the new criteria for ‘admin fasts’ will apply. PSD will no longer write sift reject letters and any outstanding information will be requested at the evaluation stage. We will review this initiative after six months to determine whether any amendments or improvements to the system are required.
Contact Information
Link to contact details for CRD
