To the attention of the holders of Mas for medicinal products for human use : update of the document ‘New definition of the approval date in SmPC and leaflet’
The document ‘New definition of the approval date in SmPC and leaflet’ was recently subject to adjustments concerning the following topics:
- a clarification concerning type IA variations
- an addition to the concerned variations: when a change leads to an additional MA, the date of the MA determines the date for implementation of the variation.
- a clarification regarding the conditions for the implementation of type II MRP variations was added.