Glossary

ABDATA (Pharma-Daten-Service) is the German producer of drug and article databases, a division of Avoxa owned by ABDA. What it makes, and how it differs from ABDA, IFA and an aggregator.

An active substance dossier (Wirkstoffdossier) is a clinical-pharmacological reference organised per active substance. Its sub-documents, how it differs from the SmPC, and the ATC and salt-form link.

AMNOG is the German law linking a new medicine's price to its proven additional benefit. The two stages, the month by month timeline, the six Zusatznutzen categories, and the retroactive Erstattungsbetrag from month 7.

API in pharma means Active Pharmaceutical Ingredient, not a software interface. ICH Q7 definition, API vs excipient, and the rules in the EU, Germany, the US.

The Apothekenverkaufspreis (AVP) is the fixed pharmacy retail price of a prescription medicine, the top of the German price cascade from ApU to AEP to AVP under the AMPreisV and §78 AMG.

Appropriate comparator therapy (zVT, zweckmäßige Vergleichstherapie): the G-BA-set yardstick against which the Zusatznutzen of a new medicine is measured in AMNOG.

The WHO ATC code classifies active substances across five levels. What each level means, the ibuprofen example, the DDD and the yearly update.

Aut idem means 'or the same': the rule under §129 Abs. 1 SGB V by which a pharmacy substitutes a wirkstoffgleiches product unless the prescriber crosses the aut-idem box. Criteria, Substitutionsausschlussliste, and aut simile.

A batch recall (Chargenrückruf) is the withdrawal of specific affected batches of a medicine from the market for a quality or safety defect. Who orders it, the recall classes I to III, and how it differs from a Lieferengpass or withdrawal.

A biosimilar is a biological medicine highly similar to an authorised reference, not a generic. The EMA definition, the 2022 interchangeability statement, and German pharmacy substitution under §40c.

C.A.V.E. is from Latin cave, beware. In pharmacy it is the ABDA patient risk-check for contraindications, allergies, age and kidney function.

A contraindication (Kontraindikation, Gegenanzeige) is a documented reason a medicine must not be used. Absolute vs relative, SmPC section 4.3, the difference from a warning, and the link to C.A.V.E.

Controlled substances (BTM, Betäubungsmittel) are any substances listed in Anlage I, II or III of the BtMG. The Anlagen compared in a table, the BtM-Rezept fields, and why Höchstmengen no longer exist.

The DDD (Defined Daily Dose) is the WHO's assumed average maintenance dose per day for drug utilisation statistics. How it works, how it differs from the prescribed dose, and its ATC link.

A declared supply shortage (Versorgungsmangel) is an officially determined shortage under §79 Abs. 5 AMG. How the Bundesministerium für Gesundheit declares it, how it differs from a Lieferengpass, and which exemptions it unlocks.

Distribution status (Vertriebsstatus) is the per-PZN status of a medicine (im Vertrieb, außer Vertrieb, zurückgezogen, nicht verkehrsfähig). What "außer Vertrieb" means and how it differs from a Lieferengpass and from Zulassung.

The dosage form (Darreichungsform) is the physical form in which a medicine is administered. EDQM Standard Terms, ISO 11239 and its role in aut-idem substitution.

A drug interaction (Wechselwirkung) is when one substance changes another's effect. Types, the ABDA severity grades, SmPC section 4.5, and how the interaction check differs from C.A.V.E.

Drug supply shortage (Lieferengpass): the BfArM two-week definition, the reporting duty under Paragraph 52b AMG, the difference from a Versorgungsmangel, and how to find substitute PZNs.

The early benefit assessment (frühe Nutzenbewertung) evaluates a new active substance under §35a SGB V, run by the G-BA with the IQWiG. The six Zusatznutzen categories, the month by month timeline, and how it differs from the Erstattungsbetrag.

EDI is the computer to computer exchange of standardised business documents such as orders and invoices. What EDI and EDIFACT are, how they differ from MSV3 and a REST API, and how pharmaceutical data fits an EDI workflow.

The Eisbergsuche® searches 25+ pharmaceutical databases at once from a single query. How it works, the per-database hit buckets and the facet filters.

The E-Rezept (electronic prescription) is the digital Rx form for GKV patients in Germany, issued into the gematik telematics infrastructure. The mandate, the three redemption routes, and how it differs from the BtM-Rezept and T-Rezept.

The EU marketing authorisation number is a medicine's regulatory licence identifier. The EU/1/YY/NNN/NNN format for centrally authorised products, how it differs from a national number and from the PZN, and where it appears in the SmPC.

The fixed reference price (Festbetrag) is the maximum amount the GKV pays for a medicine under §35 SGB V. The two-stage process, the three grouping levels, the lower-third calculation, and Zuzahlung versus Aufzahlung.

The four cheapest rule (Vier-günstigste-Regel, G4) directs pharmacies to dispense one of the four cheapest substitutable generics when no rebate contract applies. Where it comes from, why G, G4 and G-Alert mean the same thing, and why leaving the group costs volume.

A generic medicine (Generikum) has the same active substance, strength and form as the originator, approved on bioequivalence via the abridged Article 10 route. How it differs from a biosimilar, and why it drives price competition.

GTIN is the GS1 Global Trade Item Number that identifies a medicine pack in the FMD Data Matrix. How the GTIN, NTIN, PPN and the German PZN relate.

The Hilfstaxe is the DAV and GKV-Spitzenverband agreement setting how pharmacy-compounded preparations, substances and parenteral cytostatics are priced under the AMPreisV and §129 SGB V.

IDMP is the ISO set of standards that identifies a medicine unambiguously across borders. The five ISO norms, the EMA SPOR services, and MPID, PCID and PhPID explained.

IFA stands for Informationsstelle für Arzneispezialitäten, the clearing house that assigns the PZN. What IFA does, who owns it, and how its identifiers reach your systems.

Importquote and Importförderung under §129 SGB V: the tiered 15 percent / 15 euro / 5 percent price test, the 2 percent savings target, exclusions and rebate-contract priority.

The manufacturer rebate (Herstellerabschlag) is the statutory rebate to the GKV under §130a SGB V. The 7% general rebate, the 10% Generikaabschlag, the Preismoratorium to 2026, and how it differs from a Rabattvertrag.

A marketing authorisation (Zulassung) is the approval a medicine needs before market entry, granted after quality, safety and efficacy assessment. The four routes (national, MRP, DCP, centralised), who grants it in Germany, and how §21 AMG applies.

The marketing authorisation holder (Zulassungsinhaber, pharmazeutischer Unternehmer) is the legal entity that holds a medicine's authorisation. How the MAH differs from the manufacturer, and what changes on a transfer.

What is a medicinal product (Arzneimittel) in the legal sense? The two limbs of §2 AMG, the borderline against devices, supplements, cosmetics and food, and the doubt rule.

MSV3 is the German standard interface for real time availability queries and electronic ordering between pharmacies and wholesalers. Client vs server, what it does, and how both sides work on pharmazie.com.

A Nachfolge-PZN (successor PZN, Ersatz-PZN) is the new Pharmazentralnummer for a changed pack, linked in the IFA data from the Vorgängerartikel to its successor. When a PZN changes and why.

The negotiated reimbursement amount (Erstattungsbetrag) is the reimbursement price set under § 130b SGB V after the AMNOG benefit assessment. Who negotiates it, when it applies from month 7, the Leitplanken, and how it differs from Festbetrag and Rabattvertrag.

An open house contract (Open-House-Vertrag) admits every supplier accepting fixed terms, with no selection decision. Why the ECJ ruled it is not a public contract, and how §130a Abs. 8 SGB V rebate contracts work in the pharmacy.

An originator medicine (Originalpräparat) is the reference medicine, first authorised on a full clinical dossier under Article 8(3). Patents versus 8+2(+1) data and market exclusivity, what happens at patent expiry, and its role for generics and biosimilars.

What N1, N2 and N3 (Normgröße) mean on a German medicine pack: the package-size code set by the Packungsgrößenverordnung under §31 SGB V, how the N-ranges are determined, and why the code decides aut-idem substitution.

Parallel import (Parallelimport) means a medicine bought in one EU or EEA market and imported into Germany by an independent trader. How it differs from Reimport, the EU legal basis, the simplified BfArM authorisation, and the import rule in Paragraph 129 SGB V.

The patient co-payment (Zuzahlung) is the statutory amount (§61 SGB V) an insured adult pays for a prescription medicine: 10 percent, 5 to 10 euro. Exemption, Aufzahlung and Mehrkosten explained.

Pharmaceutical wholesale is the distribution stage between manufacturer and pharmacy: §52a licensing, the §52b Versorgungspflicht, full-line versus short-line, and the regulated margin.

Pharmacy compounding explained: the difference between individual (Rezeptur) and stock (Defektur) compounding, the 100-pack limit in §21 AMG, ApBetrO quality duties and Hilfstaxe pricing.

The PIL, or package leaflet (Packungsbeilage), is the patient document derived from the SmPC. Legal basis, standard sections and readability testing explained.

Prescription-only status (verschreibungspflichtig) means a medicine may be dispensed only against a valid prescription, governed by §48 AMG and the AMVV. The Rx, apothekenpflichtig and freiverkäuflich scale, and how a substance's status is set and switched.

PZN stands for Pharmazentralnummer, the eight-digit German medicine identifier from IFA. Format, modulo 11 check digit, legal basis, PPN vs NTIN vs GTIN.

A raw data licence (Rohdatenlizenz) is the licence to receive pharmaceutical master and price data in bulk, as a feed or via API, rather than only reading it on screen. What it is, why it exists, and how it differs from a subscription and a source licence.

A rebate contract (Rabattvertrag) is an agreement between a sickness fund and a manufacturer under §130a Abs. 8 SGB V. The two-year term, substitution under §129, and how it differs from a tender and an open house model.

A reference price group (Festbetragsgruppe) is the group of comparable medicines the G-BA forms under §35 SGB V so one Festbetrag applies to all of them. The three Gruppenstufen, formation, patent carve-out.

A re-imported medicine (Reimport) is a medicine made for Germany, exported and brought back. How it differs from Parallelimport and Einzelimport, the import rule in Paragraph 129 SGB V, and its own PZN.

A REST API / Webservice lets a pharmacy, wholesaler or manufacturer system pull article master data, prices and distribution status over HTTP. What it is, how it differs from SOAP, MSV3, EDI and file feeds, and how it fits a pharmaceutical workflow.

securPharm is Germany's FMD verification system. How the two-database architecture works, who verifies and decommissions, and what an alert really means.

SmPC stands for Summary of Product Characteristics, the Fachinformation approved for healthcare professionals. The 10 sections per Article 11 of Directive 2001/83/EC, how it differs from the package leaflet, and how updates reach you.

The strength (Wirkstärke) is the quantity of active ingredient per defined unit of a medicine, for example 500 mg per tablet. Salt vs active moiety, IDMP and aut-idem substitution.

A T-Rezept is the special numbered form for thalidomide, lenalidomide and pomalidomide under §3a AMVV. The substances, the six-day validity, the four- and twelve-week supply limits, the T-Register, and why it is not a BtM-Rezept.

UDI (Unique Device Identification) identifies medical devices under EU MDR 2017/745. How UDI-DI, UDI-PI and Basic UDI-DI work, issuing entities and EUDAMED.