Netherlands
NLEurope
Regulatory Overview
Netherlands is regulated by the CBG-MEB (College ter Beoordeling van Geneesmiddelen). The country has 2 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
CBG-MEB (College ter Beoordeling van Geneesmiddelen)
Regulatory Pathways (2)
Dutch named patient supply allowing pharmacists to prepare or import unlicensed medicines for individual named patients under physician prescription.
Application Form: CBG-MEB Named Patient Form
Legal Basis: Geneesmiddelenwet (Netherlands Medicines Act)
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: CBG-MEB Named Patient Guidance
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Netherlands.
Application Form: National compassionate use form
Legal Basis: Regulated under EU Directive 2001/83/EC
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: EMA Article 83 Compassionate Use
Drugs Available (24)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| mitapivat | — | — | — |
| ruxolitinib | — | — | — |
| etanercept | — | — | — |
| mannose | — | — | — |
| testosterone | — | — | — |
| Dexrazoxane | — | — | — |
| melatonin | — | — | — |
| Total Parenteral Nutrition | — | — | — |
| Betaine anhydrous | — | — | — |
| oxybutynin | — | — | — |
| sirolimus | — | — | — |
| idebenone | — | — | — |
| Carboplatin | — | — | — |
| estradiol | — | — | — |
| atidarsagene autotemcel | — | — | — |
| Laser photocoagulation therapy | — | — | — |
| N-acetylcysteine | — | — | — |
| Occupational and Physical Therapy Support | — | — | — |
| Pamidronate | — | — | — |
| ezetimibe | — | — | — |
| Growth Hormone | — | — | — |
| copper histidinate | — | — | — |
| cornstarch | — | — | — |
| mannose-1-phosphate | — | — | — |
Netherlands
| ISO Code | NL |
| Region | Europe |
| Regulatory Authority | CBG-MEB (College ter Beoordeling van Geneesmiddelen) |
| Pathways | 2 documented |
| Drugs Available | 24 drug(s) |