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Pharma Knowledge Base

Licensläkemedel (Licensed Medicine) – Sweden

Läkemedelsverket License ApplicationLäkemedelslagen (Swedish Medicinal Products Act)14 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

Swedish licensed medicine system allowing Läkemedelsverket to grant licenses for unlicensed medicines for individual patients when no suitable licensed alternative exists.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

Läkemedelsverket License Guidance

Countries Using This Pathway (1)

SE
Sweden
SE
Licensläkemedel (Licensed Medicine) – Sweden
Approval FormLäkemedelsverket License Application
Timeline14 days
Legal StatusLäkemedelslagen (Swedish Medicinal Products Act)
Source Ref.Läkemedelsverket License Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified