Mexico
MXNorth America
Regulatory Overview
Mexico is regulated by the COFEPRIS. 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
COFEPRIS
Regulatory Pathways (1)
COFEPRIS compassionate use authorization allowing access to unregistered medicines for patients with serious or life-threatening conditions in Mexico.
Application Form: COFEPRIS CU Form
Legal Basis: General Health Law Article 167
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: COFEPRIS Compassionate Use Guidelines
Drugs Available (8)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| ascorbic acid | — | — | — |
| Retinoids (Tretinoin) | — | — | — |
| Valproic Acid | — | — | — |
| Phenytoin | — | — | — |
| ivermectin | — | — | — |
| prednisone | — | — | — |
| celecoxib | — | — | — |
| emollients with keratolytics | — | — | — |
Mexico
| ISO Code | MX |
| Region | North America |
| Regulatory Authority | COFEPRIS |
| Pathways | 1 documented |
| Drugs Available | 8 drug(s) |