Comprehensive Study Guide – Netherlands
Edition Review Notes, Drug Class Tables,
Clinical Scenarios & 100 Practice Questions
with Rationales
PART 1: DUTCH PHARMACEUTICAL REGULATORY FRAMEWORK
1.1 CBG – College ter Beoordeling van Geneesmiddelen
The **College ter Beoordeling van Geneesmiddelen (CBG)** is the
independent Dutch authority responsible for evaluating the efficacy, safety,
and quality of medicines and vaccines before they can be placed on the Dutch
market. The CBG works in collaboration with the **European Medicines
Agency (EMA)** within a large European network.
**Key Functions of the CBG:**
- Assessment and authorization of medicines for humans and animals
- Classification of medicines (afleverstatus)
- Pharmacovigilance (geneesmiddelenbewaking)
- Issuing marketing authorizations for the Dutch market
**Drug Classification System in the Netherlands:**
| **Abbreviation** | **Meaning** | **Description** |
|---|---|---|
,| **UR** | Uitsluitend Recept | Prescription-only medicine |
| **UA** | Uitsluitend Apotheek | Pharmacy-only medicine |
| **UAD** | Uitsluitend Apotheek of Drogist | Pharmacy or drugstore-only |
| **AV** | Algemene Verkoop | General sale (over-the-counter) |
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### 1.2 Wet BIG – Individual Healthcare Professions Act
The **Wet BIG** (Individual Healthcare Professions Act) specifies which
professionals are authorized to prescribe UR (prescription-only) drugs in the
Netherlands.
**Who Can Prescribe UR Drugs in the Netherlands:**
- Physicians (artsen)
- Dentists (tandartsen)
- Midwives (verloskundigen)
- Physician Assistants (physician assistants)
- Nursing Specialists (verpleegkundig specialisten)
**Nurse Prescribing Authority (Voorschrijfbevoegdheid):**
There are **three groups of nurses** who may have prescribing authority
recorded in the BIG-register:
,| **Nurse Group** | **Prescribing Scope** |
|---|---|
| **Verpleegkundig Specialist** | May prescribe UR drugs within their area of
expertise |
| **Oncologieverpleegkundige** | May prescribe certain oncological
medications under specific conditions |
| **Longverpleegkundige** | May prescribe inhalation medication within
clear agreements |
**Requirements for Prescribing Authority:**
1. Registration in the BIG-register as a nurse
2. Completion of the pharmacotherapy module (module farmacotherapie)
3. Prescribing authority recorded in the BIG-register
4. A physician, dentist, or midwife must have established the diagnosis
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### 1.3 Dutch Pharmacotherapeutic Guidelines
**NHG-Standaarden (Dutch College of General Practitioners Standards):**
- Provide evidence-based recommendations for medication choice and
application in primary care
- Updated regularly based on new evidence
- Example: NHG-Standaard Diabetes mellitus type 2 includes a stepped
medication approach: Metformin remains step 1, with Gliclazide or GLP-1
agonists as step 2 options
, **SWAB – Stichting Werkgroep Antibioticabeleid (Antibiotic Policy Working
Group):**
- Aims to optimize antibiotic use in the Netherlands
- Contributes to controlling antimicrobial resistance
- Develops antibiotic stewardship guidelines and sepsis guidelines
**Farmacotherapeutisch Kompas (Pharmacotherapeutic Compass):**
- The national pharmacotherapy guideline for the Netherlands
- Provides medication information, dosing, interactions, and prescribing
advice
- Integrated with the KNMP Kennisbank
**KNMP Kennisbank (Royal Dutch Pharmacists Association Knowledge
Bank):**
- The digital information source for pharmacists
- Contains medication information, interactions, dosing, and
pharmacogenetics
- Includes the Informatorium Medicamentorum (IM) with information on all
medicines used in the Netherlands
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### 1.4 Most Commonly Used Medications in the Netherlands (2025)