Introduction

The pre-approval codes in the new SCH system will now come with an expiration date. The agency has defined the time limits as follows:

1. Time Limit for Approval Request Validity: The approval request validity with anticipation of the approval code is set for up to 120 days. For some manufacturers, particularly those whose testing duration exceeds 120 days, it is essential to establish a submission schedule that aligns with the 120-day limit and the duration of the tests.

2. Validity of Codes from the SGCH System: Codes generated in advance by the SGCH (the old system) are valid until 03/31/2017. However, exceptional cases may be evaluated until 04/30/2017, due to the requirement for using IT resources that are shared across the Agency.