19 February, 2019
The Health Sciences Authority ("HSA") has introduced a new "Do-and-Tell" option for a list of specified post-approval minor variations ("MIV-2") to enable timely implementation of changes by companies and enhance regulatory efficiency.
Under this option, companies can implement certain minor administrative changes without needing to obtain prior approval from the HSA. There are two ways in which this may be done:
Companies may consolidate all of their "Do-and-Tell" changes and submit them during the scheduled submission periods of January or July, as long as the changes were effected within a 6 month timeframe of the submission period.
Alternatively, companies may submit a "Do-and-Tell" change at any point in time as a MIV-2 submission, or together with other standard MIV-2 changes, as long as the "Do-and-Tell" change was implemented within the preceding 6 months.
If a scenario arises where the same "Do-and-Tell" change was further amended and thereafter effected once more during the 6 months timeframe, only the latest version of the change should be submitted. Should the need arise, companies can also submit their "Do-and-Tell" MIV-2 changes in an MIV-1 application (for minor variations relating to quality aspects), if the "Do-and-Tell" changes are consequential to the proposed MIV-1 changes.
More information about the approach can be found here and a quick guide can be found here. The full list of specified MIV-2 applicable for the "Do-and-Tell" variations can be found at Appendices 13C and 14C of the Guidance on Therapeutic Product Registration of Singapore, found here and here respectively.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow
andy.leck@bakermckenzie.com
