Shortage notification: notice of a supply interruption under Article 23a

Article 23a of Directive 2001/83/EC requires a marketing authorisation holder to tell the competent authority when a product is actually placed on the market, and to notify that authority if the product ceases to be placed on the market, temporarily or permanently. The notification must be made no less than two months before the interruption, other than in exceptional circumstances. Most Member States have built on this with national forms, portals and longer notice periods, and the HMA and EMA guidance on detection and notification of shortages gives a common EU definition of a shortage: supply does not meet demand at national level.

Since Regulation (EU) 2022/123 extended EMA's mandate, holders of centrally authorised products also report shortages that could lead to a crisis or affect critical medicines during a major event or public health emergency, through a single point of contact. EMA's European Shortages Monitoring Platform, launched in 2025, is becoming the channel for these reports. Shortage notifications link to several other obligations: the public service obligation in Article 81, the sunset clause if a product leaves the market for three years, and the marketing status data holders maintain in EMA systems.

A good notification names the product and presentation, the expected start and end of the interruption, the reason, stock remaining in the supply chain, alternatives, and mitigation measures such as rationing or imports. Authorities use it to decide whether to allow a temporary exemption, authorise an import or warn prescribers, which is why the two months are a minimum rather than a target.

What goes wrong: supply decisions taken in manufacturing or commercial teams reach regulatory affairs after the notice period has already run out; notifications in one Member State but not in the others where the product is marketed; and withdrawal requests filed without the cessation notice that national law requires alongside them. Repeated late notices are increasingly met with enforcement, and some Member States publish the names of holders that fail to notify.

Under the new pharma package (not yet in force), notice periods lengthen: at least twelve months before a permanent cessation or an MA withdrawal request, and at least six months before a temporary suspension or an expected disruption of more than two weeks, with a shortage prevention plan for every prescription medicine that must be handed over within two days of a request. These rules apply six months after entry into force; see shortages changes.