100+ Free Befähigungsprüfung Arzneimittelgroßhandel Practice Questions
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Key Facts: Befähigungsprüfung Arzneimittelgroßhandel Exam
GewO § 94 Z 32
Austrian Trade Code Paragraph Regulating Pharmaceutical Wholesale
Gewerbeordnung 1994 (GewO 1994)
2°C to 8°C
Strict Temperature Range Required for Cold Chain Medicinal Products
EU Good Distribution Practice (GDP) Guidelines
BASG / AGES
Austrian Competent Authority Issuing Wholesale Operating Licenses
Bundesamt für Sicherheit im Gesundheitswesen
Chemikaliengesetz 1996
Federal Statute Regulating Possession, Storage, and Trade in Poisons
BGBl. Nr. 530/1995
SecurMed Austria
National Medicines Verification Organization for Anti-Counterfeit Serialization
EU Falsified Medicines Directive 2011/62/EU
5 Years
Statutory Retention Period for GDP Wholesale Distribution Records
AMBO 2009 § 39
€0
Fee for 1st & 2nd Exam Attempt (Federally Funded Master/Trade Scheme)
WKO Meisterprüfungsstellen
AMBO 2009
Austrian Medicinal Products Operations Ordinance for Wholesalers
BGBl. II Nr. 148/2009
The Austrian Befähigungsprüfung Großhandel mit Arzneimitteln und Giften is the statutory trade competence qualification administered by the WKO across EU GDP regulations, cold chain management, poison law, and anti-counterfeiting serialization.
Sample Befähigungsprüfung Arzneimittelgroßhandel Practice Questions
Try these sample questions to test your Befähigungsprüfung Arzneimittelgroßhandel exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.
1Under the Austrian Arzneimittelbetriebsordnung 2009 (AMBO 2009), who is ultimately accountable for the Quality Management System at a pharmaceutical wholesaler?
2What is the primary EU guideline governing the distribution of medicinal products?
3Which authority in Austria issues the Großhandelsbetriebsbewilligung (wholesale distribution authorization)?
4Which law forms the fundamental legal basis for medicinal products in Austria?
5Must a pharmaceutical wholesaler appoint a Responsible Person (Verantwortliche Person)?
6How often should self-inspections be conducted under GDP guidelines?
7What does a Pharmaceutical Quality System (PQS) ensure?
8What is the standard temperature range for 'cold chain' medicinal products?
9What must be done before using a new storage area for temperature-sensitive products?
10How should returned medicinal products be handled initially?
About the Befähigungsprüfung Arzneimittelgroßhandel Exam
The Befähigungsprüfung Großhandel mit Arzneimitteln und Giften is the statutory trade competence examination in Austria required to operate a pharmaceutical and poisons wholesale business (reglementiertes Gewerbe under § 94 Z 32 GewO 1994) or act as a designated trade manager (gewerberechtlicher Geschäftsführer). Governed by the Austrian Trade Code, the Arzneimittelgesetz (AMG), AMBO 2009, EU GDP Guidelines, and the poison provisions of the Chemikaliengesetz 1996, this examination ensures high standards of drug quality, supply chain security, cold chain integrity, and hazardous substance management. This practice bank offers an English-language MCQ study adaptation covering GDP workflows, regulatory inspection standards, serialization compliance via SecurMed Austria, and poison distribution laws.
Assessment
Four modules under the Arzneimittel- und Giftgroßhandel-Befähigungsprüfungsordnung per GewO 1994 § 94 Z 32. Modul 1: Fachlich schriftliche Prüfung (pharmaceutical law, GDP, pharmacology, poison law). Modul 2: Fachlich mündliche Prüfung. Modul 3: Ausbilderprüfung. Modul 4: Unternehmerprüfung. Graduates in pharmacy or medicine may obtain exemptions for specific subjects in Modul 1.
Time Limit
Written Modul 1: up to five hours for 'Betriebsorganisation und Qualitätsmanagement schriftlich' plus up to one hour for 'Pharmakologie'; oral Modul 2 for Großhandel mit Arzneimitteln und Giften: 45–60 minutes
Passing Score
School grade scale 'Sehr gut' to 'Genügend' across all subjects in each module
Exam Fee
Free for the 1st & 2nd attempt at Modules 1, 2, 4 (federally funded since 1 Jan 2024); third attempt onward subject to percentage fee schedule (WKO Meisterprüfungsstellen / Bundesgremium des Arzneimittelgroßhandels)
Befähigungsprüfung Arzneimittelgroßhandel Exam Content Outline
Austrian & European Pharmaceutical Wholesale Law & GDP
Arzneimittelgesetz (AMG), AMBO 2009, EU Guidelines on Good Distribution Practice (2013/C 343/01), role and statutory duties of the Responsible Person (Verantwortliche Person), wholesale distribution authorization by BASG/AGES.
Quality Management, Storage, Cold Chain & Operations
Pharmaceutical quality system (PQS), temperature mapping, continuous temperature monitoring, cold chain (2°C–8°C vs 15°C–25°C), qualification of storage equipment, transport validation, returns, quarantine, and CAPA.
Poisons, Hazardous Substances & Chemicals Legislation
Austrian poison law in the III. Abschnitt of the Chemikaliengesetz 1996 (ChemG 1996) and the Giftverordnung 2000, EU REACH and CLP classification, who may supply and acquire Gifte, acquisition authorisations (Giftbezugsbewilligung as Giftbezugsschein or Giftbezugslizenz, and the Giftbezugsbescheinigung for businesses), the Giftbeauftragter and Sachkunde requirement, secure segregated storage, and the statutory Giftaufzeichnungen.
Falsified Medicines Directive & Controlled Substances
EU Falsified Medicines Directive (2011/62/EU), serialization, 2D DataMatrix verification/decommissioning via SecurMed Austria (NMVO), Suchtmittelgesetz (SMG) & Suchtgiftverordnung for wholesale trade, and supplier/customer qualification.
How to Pass the Befähigungsprüfung Arzneimittelgroßhandel Exam
What You Need to Know
- Passing score: School grade scale 'Sehr gut' to 'Genügend' across all subjects in each module
- Assessment: Four modules under the Arzneimittel- und Giftgroßhandel-Befähigungsprüfungsordnung per GewO 1994 § 94 Z 32. Modul 1: Fachlich schriftliche Prüfung (pharmaceutical law, GDP, pharmacology, poison law). Modul 2: Fachlich mündliche Prüfung. Modul 3: Ausbilderprüfung. Modul 4: Unternehmerprüfung. Graduates in pharmacy or medicine may obtain exemptions for specific subjects in Modul 1.
- Time limit: Written Modul 1: up to five hours for 'Betriebsorganisation und Qualitätsmanagement schriftlich' plus up to one hour for 'Pharmakologie'; oral Modul 2 for Großhandel mit Arzneimitteln und Giften: 45–60 minutes
- Exam fee: Free for the 1st & 2nd attempt at Modules 1, 2, 4 (federally funded since 1 Jan 2024); third attempt onward subject to percentage fee schedule
Keys to Passing
- Work through all 100 available questions
- Review every answer and explanation
- Track weak areas and revisit them
- Use our AI tutor for tough concepts
Befähigungsprüfung Arzneimittelgroßhandel Study Tips from Top Performers
Frequently Asked Questions
What is the Befähigungsprüfung Großhandel mit Arzneimitteln und Giften in Austria?
It is the official trade competence examination in Austria administered by the WKO Meisterprüfungsstellen under § 94 Z 32 of the Gewerbeordnung 1994. Passing this examination demonstrates the professional qualification required to obtain a trade license (Gewerbeberechtigung) for wholesale trade in pharmaceuticals and poisons.
What role does the Responsible Person (Verantwortliche Person) play in Austrian pharma wholesale?
Under AMBO 2009 and EU GDP guidelines, every pharmaceutical wholesaler must appoint a designated Responsible Person (RP / Verantwortliche Person) who possesses appropriate qualifications and personal reliability. The RP is personally responsible for establishing and maintaining the quality management system, approving suppliers/customers, managing recalls, and ensuring compliance with all GDP rules.
What are the temperature monitoring requirements under EU GDP?
Wholesalers must maintain validated temperature control: standard room temperature storage (15°C to 25°C) and cold chain storage (2°C to 8°C). Initial thermal mapping must be performed across seasonal extremes, continuous calibrated temperature loggers must be installed in critical locations, and automatic alarm systems must alert staff to excursions.
What regulations govern wholesale trade in poisons in Austria?
Poison trade is governed by the III. Abschnitt of the Chemikaliengesetz 1996 and by the Giftverordnung 2000. Regulated poisons (substances classified as acutely toxic Cat. 1, 2, or 3 under CLP/GHS) may only be supplied to persons entitled to acquire them — holders of a Giftbezugsbewilligung (issued either as a Giftbezugsschein for a single purchase or as a Giftbezugslizenz for repeated purchases), businesses holding a Giftbezugsbescheinigung, or trades entitled ex lege such as pharmacies, Drogisten and manufacturers of and wholesalers in medicinal products and poisons. Continuous annual records of poisons handled must be kept.
How does the EU Falsified Medicines Directive apply in Austria?
Under Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, prescription medicines must carry safety features: an anti-tampering device (ATD) and a unique identifier in a 2D DataMatrix code. Wholesalers must verify and decommission products through the national repository system SecurMed Austria in designated high-risk workflows (e.g. exports, returns, destroyed products).
How does this practice bank adapt the Austrian trade exam?
The official examination is a German-language written and oral assessment administered by the WKO. This practice bank provides an English-language MCQ study adaptation designed to test regulatory GDP frameworks, poison distribution requirements, cold chain validation, and serialization management.