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Did you know that PV regulatory intelligence in iViReg is expanding to LATAM countries? Here is a brief update on reporting requirements in Mexico.
In line with 201EMODIFICACI\xD3N a la Norma Oficial Mexicana NOM-220-SSA1-2016 201C reporting times for AE (Adverse event), SRAM (Suspected Adverse Drug Reaction) and RAM (Adverse Drug Reaction) occurred in Mexico are as followed:
Serious Fatal cases: 7 calendar days
Other Serious cases: 15 calendar days
Non-Serious cases: 90 calendar days
Two (2) or more serious adverse events occurring at the same place with drugs from the same batch: 48 hours
Notification from the scientific literature: 30 calendar days
You can search through iViReg and find out more information. Feel free to get in touch with the iViReg team at ivireg@ivigee.com.