HSA Singapore has launched on 20 August 2021 a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders to get quick answers on the application type, variation category and documentary requirements for such variations. The tool also serves as an interactive guide to equip industry stakeholders with the regulatory information for good quality submissions, thereby enabling applicants to make the correct application type and submit the required supporting documents.
This is part of HSA’s ongoing efforts to enhance clarity in their regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry. Industry stakeholders can now use this self-guided tool in lieu of sending email enquiries to HSA, which is faster and more convenient.
There are no technical changes made to the application types, variation categories or documentary requirements.
The tool may be accessed on the HSA website at this link: https://www.hsa.gov.sg/therapeutic-products/variation-application/miv-tool