Pack sizes and primary packaging
Do pharmaceutical entrepreneurs always have to market all pack sizes licensed?
No.
Is the reference "Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht." ["Possibly not all pack sizes will be marketed."] in Package Leaflet and the German "Fachinformation" permissible?
Yes.
Is the distribution and/or the nondistribution of licensed pack sizes subject to the notification requirement?
What must be considered both when submitting notifications of variations of the pack sizes as well as notifications of variations of primary packaging?
When changing the pack size (addition or deletion), the type of immediate packaging material to which this change refers always has to be stated concurrently. Vice versa, if the type of immediate packaging material is altered (removal of previous immediate packaging material or addition of new immediate packaging material) it is to be stated which pack sizes are affected.