Denmark ends foreign-pack stopgap for Paracetamol AL suppositories as Danish packs return

What happened

On 9 November the Danish Medicines Agency (DKMA) announced it will end its section 29(2) permission for German-authorised Paracetamol AL "Aliud" suppositories. The 500 mg and 1000 mg strengths each have their own notice, and both take effect on 12 November. DKMA's stated reason is that marketed Danish packs are available again.

The permission had allowed foreign-language packs of the German-authorised product to be prescribed and dispensed in Denmark. Once it is deactivated, that route closes for these two strengths. The records do not say how long the permission was in place, what caused the original shortage, or how much foreign-pack product was dispensed. We do not speculate on those points.

Why it matters for market access

Shortage exemptions of this kind are usually temporary. They are tied to a specific supply gap and are withdrawn once the gap closes. The DKMA decision shows the mechanism working in both directions: the agency opens a route when supply fails and closes it when a marketed national pack returns.

For market access teams the practical point is that pack-level availability determines which product a pharmacy can supply. In a shortage, a foreign-pack alternative may be dispensed. When national supply returns, the national pack becomes the expected product again. Pricing, reimbursement and tender assumptions built on the workaround product should not be carried forward after the cut-off date.

The notice is also a reminder that a supplier whose national packs are back on the market has a short window to restore normal supply chains. This applies to wholesalers, hospital pharmacies and community pharmacies that stocked the imported packs.

Regulatory context

Under national medicines legislation, agencies can allow medicines that lack a national marketing authorisation, or a national pack, to be supplied when the authorised product cannot be obtained. Denmark's section 29(2) is one such tool. These permissions are product-specific and are published on the agency's shortage pages. They are typically reviewed as supply changes, which is what DKMA has done here.

The two notices are procedurally identical, one per strength. Teams tracking the product should check both. A portfolio view that treats the 500 mg and 1000 mg strengths as a single item could miss a change in one.

The wider supply picture

The same day brought other supply-related signals from European regulators, though none is connected to the Danish decision on the evidence we have. Greece's EOF published a notice that Merck Sharp & Dohme plans to permanently stop marketing EMEND (aprepitant) capsules across the EU/EEA, with Greece named among the affected countries. The records give no withdrawal date and no information on alternatives. EOF also issued a corrected repeat of its 31 October list of medicinal products with limited availability on the Greek market.

These items point in different directions. In Denmark, supply is recovering and a workaround is ending. In Greece, a permanent withdrawal and a revised limited-availability list show that supply constraints can be structural as well as temporary. Teams that manage multi-country portfolios should treat them as distinct categories: a temporary gap, which exemption tools can bridge, and a permanent exit, which cannot.

Medical device supply was also in the news. The Dutch inspectorate IGJ published field safety notices from Abiomed (Impella controller and purge cassette detection), Intersurgical (spirometry sets and anaesthetic breathing systems), Fisher Diagnostics (Infinity Ammonia Reagent on Beckman Coulter AU analysers) and Hitachi (cobas c 303 vacuum tubing). Health Canada separately flagged an Intersurgical Smoothbore breathing system recall. These are quality and safety actions rather than medicine shortages, but hospital procurement teams may need to manage substitution and continuity for them in similar ways.

What to watch

First, watch whether DKMA's page shows any further changes after 12 November, including whether other foreign-pack permissions are deactivated as national supply returns. Second, watch whether Danish supply of the two strengths stays stable once the imported packs leave the system. The records give no information on stock levels, so any view on resilience would be conjecture.

Third, for EMEND, the open questions are the withdrawal timing in each member state and the national responses. None of that is in the records yet.