Singapore - HSA Makes Amendments To Categorisation Of Post-Approval Variations (MAV-1 And MIV).
Legal News & Analysis - Asia Pacific - Singapore - Regulatory & Compliance
19 February, 2019
The HSA has re-categorised the inclusion of clinical information on concomitant administration of vaccines in the product label from MAV-1 to MIV-1. MAV-1 refers to any variation to the indications, dosing regimens, patient population and/or inclusion of clinical information for extending the use of a registered product, while MIV-1 refers to a minor variation to the quality aspects and/or labelling of a therapeutic product.
These changes take into consideration the fact that updates relating to the potential interference between co-administered vaccines do not entail extension of the use of the product.
The HSA has also announced that certain MIV-1s will be re-categorised to MIV- 2s. MIV-2 refers to a minor variation or an administrative change. The relevant MIV-1s that will be re-categorised are as follows:
- Alignment of the Package Insert/Patient Information Leaflet of generic drugs with the corresponding current labels of the Singapore Reference Product;
- Addition or amendment of information on “Instructions for Use” for products with special delivery system/device (e.g. transdermal patches, inhalers, prefilled syringes, etc.); and
- Addition or amendment to the Drug interactions and overdose sections that result in strengthening of safety information or restriction of use.
The HSA elaborates these re-categorisation changes seek to refine their regulatory approach and to simplify the regulatory filing process for safety and administrative changes.
More information about the approach can be found here.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow