Compassionate Use Programme – Brazil (ANVISA)
ANVISA Form 25351-1 (Expanded Access Request)Statutory45 days
Description & Eligibility
Brazil's Programa de Acesso Expandido allows access to investigational drugs not yet registered with ANVISA for patients with serious or life-threatening conditions. The programme requires submission through the prescribing physician and institutional ethics committee approval.
Eligibility Criteria
Patients with serious/life-threatening diseases without therapeutic alternatives, enrolled through authorized healthcare institutions
Legal Reference / Source
RDC 38/2013 ANVISA
Compassionate Use Programme – Brazil (ANVISA)
| Approval Form | ANVISA Form 25351-1 (Expanded Access Request) |
| Timeline | 45 days |
| Legal Status | Statutory |
| Source Ref. | RDC 38/2013 ANVISA |
| Countries | 0 countries |
Compliance Check
Legal Review3/21/2026
Global ValidityVerified