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CLNR

The Ministry of Health informed that a draft order amending the rules on medicine supply through the special needs procedure (ANS) was published in consultation.

The proposal would allow ANMDMR to start authorizing a new quantity when previously authorized stocks fall to 30%, compared with the current 10% threshold, remove intermediate administrative steps by allowing ANMDMR to contact the Ministry’s specialty commissions directly, and introduce an explicit obligation for ANMDMR to continuously monitor stocks of medicines authorized for special needs and intervene when supply can no longer be ensured through regular distribution channels.