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TL;DRDistribution status (Vertriebsstatus) is the per-pack status of a pharmaceutical article in the German IFA article master data, recording whether the exact PZN is im Vertrieb (in distribution), außer Vertrieb (withdrawn from distribution), zurückgezogen or nicht verkehrsfähig. It answers a commercial question: is this pack being sold?
That question is separate from whether the product is legally allowed on the market. A medicine can hold a valid marketing authorisation and still be flagged "außer Vertrieb" because the company has stopped delivering that pack. Conversely a pack can be fully "im Vertrieb" and still be caught in a Lieferengpass, a temporary bottleneck. Keeping the distribution status, the regulatory status and a shortage apart is the whole point of the field, because each one implies a different next step for a dispensing, substitution or procurement decision.
The status is managed by the IFA (Informationsstelle für Arzneispezialitäten), the body that assigns the PZN and maintains status data for the German pharmacy market. Its published rules define five article states, and the boundaries between them are precise. For an overview of the body itself see IFA.
"Außer Vertrieb" (AV) means the supplier has taken that pack out of distribution and no longer delivers it. The supplier reports this to the IFA as an AV-Meldung. Per the IFA rules the withdrawal should be final, with no later resumption intended, and the flag refers to exactly one article, one PZN. Stock already in the trade (Lagerware) may still be sold off, provided the article is still verkehrsfähig, so dispensing and substitution from remaining stock can continue for a while after the AV date.
Two properties matter operationally. An AV article cannot be reactivated: it cannot be set back to "im Vertrieb", and a relaunch requires a new PZN. And a temporary supply difficulty is explicitly not a reason for an AV-Meldung; that is a Lieferengpass, a different concept with a different data source.
These three are routinely conflated, yet they answer different questions. Distribution status is commercial (is it being sold), Verkehrsfähigkeit and the Zulassung are regulatory (is it allowed on the market), and a Lieferengpass is a temporary availability problem for a product that is still marketed. The table sets them apart.
| Concept | Question it answers | Typical trigger | Where it lives |
|---|---|---|---|
| Distribution status (außer Vertrieb) | Is this pack still being distributed? | The company stops delivering the pack (final) | Article master data, per PZN, reported to the IFA |
| Verkehrsfähigkeit / Zulassung | Is this product legally allowed on the market? | Withdrawal of the Zulassung, an ordered recall, a court decision | Regulatory (BfArM/EMA); mirrored as status "nicht verkehrsfähig" (NV) |
| Lieferengpass | Is it temporarily hard to deliver right now? | Production issue or demand spike; the product stays on the market | BfArM shortage report, not a distribution status |
The practical reading: "außer Vertrieb" tells you this specific pack is gone for good and you should look at a successor PZN, "nicht verkehrsfähig" tells you the product may not be sold at all (remaining stock must not be dispensed), and a Lieferengpass tells you the pack is authorised and marketed but temporarily constrained, so a substitution or a wait may be the answer.
The IFA rules define five states an article can be in. Each carries its own consequence for whether stock may be sold and whether a successor can be referenced.
| Code | Status | Meaning | Sell-off of stock |
|---|---|---|---|
| IV | im Vertrieb | Actually available and distributed by the supplier; the default for a newly listed article. | Yes |
| AV | außer Vertrieb | Taken out of distribution, final, no reactivation; refers to one PZN. | Yes, while still verkehrsfähig |
| ZG | zurückgezogen | Withdrawn from the German market under the AMNOG framework (§130b SGB V); permanently unavailable. | No |
| NV | nicht verkehrsfähig | Has lost its marketability, for example after withdrawal of the Zulassung or an ordered recall. | No |
| LÖ | gelöscht | Removed from the IFA data; the PZN is retired and not re-published. | n/a |
The distinction between AV and ZG is easy to miss. Both remove a product, but AV is a plain commercial withdrawal where remaining stock may still be dispensed, while ZG is a formal market withdrawal tied to the AMNOG price-negotiation framework under §130b SGB V, after which stock is no longer for dispensing and no successor can be referenced. See also Rabattvertrag for the wider reimbursement context.
Setting a pack to "außer Vertrieb" starts a defined sequence in the article data. The steps below follow the IFA rules on status changes and deletion.
The 24-month window for pharmacy-only medicines is deliberate: it keeps the withdrawn article visible long enough to cover the usual legal sell-off periods, so a professional can still identify a pack encountered in the field and trace it to its successor.
pharmazie.com aggregates the ABDA article master data (via ABDATA), so the Vertriebsstatus and the Außer-Vertrieb-Datum are carried per PZN and refreshed daily with a data stamp. The value of having it inside the platform is the link: an "außer Vertrieb" pack sits next to its successor PZN and, where the product is caught in a shortage rather than withdrawn, next to the daily Lieferengpass feed and its substitute PZNs. That lets a user tell apart the three cases, withdrawn, unmarketable, or temporarily short, on one screen rather than guessing from a single flag.
One honest limitation: the distribution status is a supplier self-declaration mirrored from the article master data, not a live warehouse feed. It records what the company has reported about distribution, and pharmazie.com is an aggregator of that licensed data rather than the legal register. The authoritative status and the exact dates are held by the IFA and the responsible pharmaceutical company.
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