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TL;DRA declared supply shortage (Versorgungsmangel) is an officially determined pharmaceutical shortage: under §79 Abs. 5 AMG the Bundesministerium für Gesundheit declares that a shortage of medicines needed to prevent or treat life-threatening illnesses exists, which unlocks temporary legal exemptions to secure supply.
The word is easy to blur into the everyday term for a shortage, but in German pharmaceutical law it is a specific, formal act with legal consequences. A declared supply shortage is not a manufacturer's report and not a status in the article master data. It is a determination by the federal health ministry, published in the Bundesanzeiger, that a supply gap has reached a point where the normal rules of the Arzneimittelgesetz can be temporarily loosened.
That distinction is the whole point. A single active ingredient can be in short supply for months while the market absorbs it quietly. A declared supply shortage is issued only when the shortage threatens the treatment of serious illness and the ordinary supply channels are no longer enough. Once it is declared, competent authorities gain powers they do not otherwise have.
A Lieferengpass is a manufacturer's self-reported delivery bottleneck; a declared supply shortage is a higher, formal ministerial determination that unlocks legal exemptions. The two sit at different levels of the same escalation, and not every Lieferengpass becomes a Versorgungsmangel. Most do not. The table sets the two apart, with the distribution status Vertriebsstatus shown alongside for orientation.
| Concept | What it is | Who sets it | Legal basis / channel |
|---|---|---|---|
| Lieferengpass | A supply interruption expected to last more than two weeks, or an unmet spike in demand. The product is still on the market, just not deliverable in the usual volume. | The pharmaceutical company, by self-report to the BfArM | Reporting duty under §52b AMG, published on the BfArM shortage list |
| Versorgungsmangel | A formally determined shortage of medicines for life-threatening illnesses that threatens supply and triggers regulatory exemptions. | The Bundesministerium für Gesundheit, on the basis of BfArM findings | §79 Abs. 5 AMG, by Bekanntmachung in the Bundesanzeiger |
| Außer Vertrieb | A distribution status in the article master data: the company has withdrawn this specific pack. A lasting state for that PZN, not a temporary bottleneck. | The pharmaceutical company, via the article data | Vertriebsstatus field, not a shortage act |
The practical reading: a Lieferengpass is a warning that a substitution may be needed, while a declared supply shortage is the state in which the rules for that substitution actually loosen. A shortage register tells you a product is constrained. The ministerial determination tells you what pharmacies and authorities are now permitted to do about it.
The Bundesministerium für Gesundheit declares it, acting on findings from the BfArM and with the involvement of the responsible authorities, and publishes the determination in the Bundesanzeiger. The statute is precise about the trigger: §79 Abs. 5 AMG opens with the case of a Versorgungsmangel affecting medicines "die zur Vorbeugung oder Behandlung lebensbedrohlicher Erkrankungen benötigt werden", that is, medicines needed to prevent or treat life-threatening illnesses. The path runs in fixed steps.
Recent published examples make the mechanism concrete: a Bekanntmachung of 25 July 2025 determined a Versorgungsmangel for acetylsalicylic acid in intravenous form, and an earlier determination covered antibiotic juices for children. Each names specific products and specific permitted measures rather than loosening the law in general.
It lets the competent authorities permit, on a case-by-case and time-limited basis, deviations from rules that would normally block a product from reaching patients. Under §79 Abs. 5 AMG the authorities may allow medicines that are not authorised in Germany to be placed on the market temporarily and to be imported by way of derogation from the standard route in §73 Abs. 1 AMG, and may permit temporary departures from permit, approval or other prohibitions under the Act.
In operational terms, as set out in the BfArM measures, a determination typically permits the sale of packs carrying foreign-language labelling and package leaflets, the distribution of medicines that are lawfully marketed in the country of import but not authorised in Germany, and batch release even where the pack does not carry the latest approved Packungsbeilage. Such packs overlap in practice with the logic of a Reimport, though the legal basis here is the shortage determination, not a parallel-trade licence. §79 Abs. 6 AMG adds that any such measure must be limited to what is necessary and appropriate to the danger the shortage creates.
The ALBVVG, the Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz of 2023, strengthened the whole shortage framework around §79 rather than replacing it. It broadened the BfArM's monitoring and information powers, tied measures to lists of supply-critical medicines, and reinforced the pathway by which a reported shortage can escalate to a determined Versorgungsmangel with enabling exemptions. For a manufacturer or wholesaler, the ALBVVG is the reason the data flowing to the BfArM is now denser, and the reason a Versorgungsmangel determination rests on a fuller evidence base than it once did.
pharmazie.com surfaces the daily BfArM Lieferengpass feed with concrete substitute PZNs, which is the layer that turns a shortage into a next action; the Versorgungsmangel determination itself remains the authority's legal act, published in the Bundesanzeiger. The two roles should not be confused. The platform is an aggregator of licensed article and shortage data, not the body that declares a shortage, and it does not carry the competing standard price service data.
Where the platform earns its place is the substitution decision that a determination makes urgent. When a declared supply shortage loosens the rules on foreign-labelled or foreign-authorised packs, a supply team still has to find a specific, orderable alternative. On pharmazie.com each shortage entry is shown next to substitute products, each identified by an available PZN, and where relevant the search extends to EU and international alternatives, which is exactly the kind of foreign product a determination may permit.
One honest limitation: pharmazie.com surfaces the underlying Lieferengpass and article data, but it is not the source of truth for whether a Versorgungsmangel has been declared. That status is set by the Bundesministerium für Gesundheit in the Bundesanzeiger and by the BfArM measures pages, and the binding wording of any exemption lives there, so a determination and its exact conditions should always be checked against the official Bekanntmachung.
