基本上是基於2001/83/E指令
Aricle 23 a
obliges the marketing authorisation holder to notify the authority if a product ceases to be placed on the market even temporarily.
在斷藥前(即便是暫時性)都有責任要通知CA
另外在article 81提到
The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
MAH以及藥品盤商有供應藥物的責任
但也並非哩哩砸砸阿里布達的藥都要執行，通常是該國家基礎必須用藥(essential medicine)，部分國家跟台灣一樣是採用WHO公告之必須用藥，在這範疇下就必須進該義務職責。
某些國家對於斷藥會有懲處，特別是有簽健保及供應合約的，這部分就需要去詳讀該國法規。
