Welcome to the electronic form of the Regional Online Reporting System of Suspected Adverse Reactions to medicines and vaccines for human use.

On this Website, you will be able to report possible suspected adverse effects to medicines and vaccines for human use to the National Pharmacovigilance Centers in Central America and the Dominican Republic. This contributes to knowing the adverse reactions that occur during the use of medicines that are authorized in the SICA Member States, in an agile and timely manner.

An adverse reaction can occur after the administration of a medicine or a vaccine. These may not be expected or desired and can appear even after a person has stopped using the medication, or even after the administration of a vaccine while some adverse reactions may not be discovered until many people have used the medication for a long period of time. For this reason, the contribution/support of citizens or patients, health professionals and the pharmaceutical industry to report suspected adverse reactions they detect is needed, thereby contributing to the surveillance of the safe use of medicines in the Member States of SICA..

For more information about the notification process we leave you at your disposal:
Citizen Notification Manual (Click here )
Health Professional Notification Manual (Click here)
Pharmaceutical Industry Notification Manual (Click here)

If you require support in the notification process, contact notifacedra@comisca.org