Stroški v zvezi z drugimi spremembami, ki niso navedene v 5., 6. in 7. členu tega pravilnika so naslednji:
+--------------------------------------------------------------------+------+ |1. stroški priglasitve spremembe tipa IA in IB pri: | | +--------------------------------------------------------------------+------+ |– NP | 50| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 40| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 660| | | točk| +--------------------------------------------------------------------+------+ | | | +--------------------------------------------------------------------+------+ |2. stroški priglasitve spremembe tipa IA in IB za dodatno | | |farmacevtsko obliko in/ali jakost v skupnem predlogu za odobritev | | |spremembe pri: | | +--------------------------------------------------------------------+------+ |– NP | 20| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 20| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 250| | | točk| +--------------------------------------------------------------------+------+ | | | +--------------------------------------------------------------------+------+ |3. stroški odobritve spremembe tipa II pri: | | +--------------------------------------------------------------------+------+ |– NP | 70| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 60| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 930| | | točk| +--------------------------------------------------------------------+------+ | | | +--------------------------------------------------------------------+------+ | | | |4. stroški odobritve spremembe tipa II za dodatno farmacevtsko | | |obliko in/ali jakost v skupnem predlogu za odobritev spremembe pri: | | +--------------------------------------------------------------------+------+ |– NP | 30| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 30| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 400| | | točk| +--------------------------------------------------------------------+------+ | | | | | | +--------------------------------------------------------------------+------+ |5. stroški priglasitve spremembe tipa IA, IB in II, ki se obravnava | | |na podlagi inšpekcijskega pregleda ali mnenja izvedenca pri: | | | | | +--------------------------------------------------------------------+------+ |– NP | 100| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 80| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 1750| | | točk| +--------------------------------------------------------------------+------+ | | | +--------------------------------------------------------------------+------+ |6. maksimalni stroški priglasitev oziroma odobritev sprememb tipa | | |IA, IB in II iste farmacevtske oblike za različne jakosti in | | |pakiranja v skupnem predlogu za spremembo dovoljenja za promet z | | |zdravilom pri: | | | | | +--------------------------------------------------------------------+------+ |– NP | 300| | | točk| +--------------------------------------------------------------------+------+ |– MRP-CMS | 250| | | točk| +--------------------------------------------------------------------+------+ |– MRP-RMS | 5000| | | točk| +--------------------------------------------------------------------+------+