13 July, 2018
The Health Sciences Authority ("HSA") has introduced a new self-guided algorithm for post-approval variation applications ("MIV"), as part of ongoing efforts to enhance clarity and transparency in the healthcare regulatory process.
The new self-guided algorithm, which enables applicants to determine the application type, variation category and the documentary requirements for MIVs, has been implemented into the revised MIV Filing and Submission Enquiry Form (the "Enquiry Form"). There are no technical changes made to the application types, variation categories or documentary requirements.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow
andy.leck@bakermckenzie.com
