Belgium
BEEurope
Regulatory Overview
Belgium is regulated by the FAMHP (Federal Agency for Medicines and Health Products). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
FAMHP (Federal Agency for Medicines and Health Products)
Regulatory Pathways (1)
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 Belgium.
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 (6)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| mannose | — | — | — |
| testosterone | — | — | — |
| sirolimus | — | — | — |
| efgartigimod alfa | — | — | — |
| Laser photocoagulation therapy | — | — | — |
| Pamidronate | — | — | — |
Belgium
| ISO Code | BE |
| Region | Europe |
| Regulatory Authority | FAMHP (Federal Agency for Medicines and Health Products) |
| Pathways | 1 documented |
| Drugs Available | 6 drug(s) |