Sweden
SEEurope
Regulatory Overview
Sweden is regulated by the MPA (Medical Products Agency). 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
MPA (Medical Products Agency)
Regulatory Pathways (2)
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 Sweden.
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
Swedish licensed medicine system allowing Läkemedelsverket to grant licenses for unlicensed medicines for individual patients when no suitable licensed alternative exists.
Application Form: Läkemedelsverket License Application
Legal Basis: Läkemedelslagen (Swedish Medicinal Products Act)
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: Läkemedelsverket License Guidance
Drugs Available (11)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| naproxen | — | — | — |
| Total Parenteral Nutrition | — | — | — |
| Growth hormone (somatropin) | — | — | — |
| Nitisinone | — | — | — |
| idebenone | — | — | — |
| estradiol | — | — | — |
| N-acetylcysteine | — | — | — |
| Occupational and Physical Therapy Support | — | — | — |
| ezetimibe | — | — | — |
| Growth Hormone | — | — | — |
| cornstarch | — | — | — |
Sweden
| ISO Code | SE |
| Region | Europe |
| Regulatory Authority | MPA (Medical Products Agency) |
| Pathways | 2 documented |
| Drugs Available | 11 drug(s) |