The EU package's shortage rules: twelve months' notice before a withdrawal, six before a suspension, and a Union list of critical medicines

Where it stands

The Council adopted its first-reading position on the pharmaceutical package on 28 September 2026. Parliament’s health committee was due to vote its second-reading recommendation on 10 November 2026 with a plenary vote in the same month, and publication in the Official Journal is expected before the end of 2026. Most of the package applies two years after entry into force, so from late 2028. The shortage provisions do not wait that long.

What changes

Notice before a product goes. Today a marketing authorisation holder must tell the authorities two months before a product is withdrawn or supply is interrupted. Under the package the holder must notify the national authority at least twelve months before permanently withdrawing a marketing authorisation or ceasing supply in a Member State, and at least six months before a temporary suspension or any supply disruption it expects to last more than two weeks. A shorter disruption must still be reported without delay. The notices go to the national authority and, through it, to the European Medicines Agency’s shortages steering group.

A prevention plan for every prescription medicine. Holders must keep a shortage-prevention plan for every prescription-only medicine, and for any product the Commission designates as critical, and be able to produce it within two days of a request. There is no transition period for products already authorised.

Union lists. The Commission will consolidate the national critical-medicines lists into a Union “long list” and adopt a Union list of critical medicinal products, with a first revision within a year of entry into force. The Agency’s steering group will run vulnerability assessments of the supply chains behind those products. The Commission’s power to impose contingency stocks by implementing act, which was in the original proposal, was cut back in the compromise.

When. On the timetable reported in October 2026, the critical-medicines provisions apply on entry into force and the notification and prevention-plan duties six months later, which puts both in 2027.

What it means if you are…

A parallel trader or wholesaler. A twelve-month notice before a product leaves a market, and six months before a suspension, is a formal early signal of the supply changes that create and close arbitrage. Notices are made to authorities, not published as such, but the Agency’s shortage lists and the national registers will reflect them earlier and more consistently than today. The same rules will make a sudden withdrawal in a low-price source country less likely to strand stock.

A generics or launch planner. The burden lands on every marketing authorisation holder, which for a generics company means a plan per product across the whole portfolio from 2027, with no grace period for existing products. Portfolio pruning will need a year’s notice per country, which changes how quickly an unprofitable national authorisation can be dropped. Being on the Union critical list will also bring the tender and stockholding attention of the Critical Medicines Act, covered separately.

A buyer. The Union critical list is the anchor for contingency stocks and tender design; expect hospital procurement to reference it. The notice periods give purchasers a year’s warning of permanent withdrawals, if the authorities pass the information on.

What to watch

The Official Journal text and the confirmed application dates; the Commission’s first Union list and the Agency’s vulnerability assessments; and the national decisions on how, and whether, notices are made public.