Introduction | Definition | Objectives | Importance | Commitment | Terminology Adverse Events Report |


Adverse Effect (AE)

See Adverse Reaction


Adverse Event (Adverse Experience)  

Any medical unfortunate occurrence in a patient or subject under clinical research who was administered a drug and that may or may not have a causal relation to this treatment.


Adverse Reaction

Any prejudicial undesired effect present in the doses employed in people for prophylaxis, diagnosis, therapeutic or the modification of a physiological function.



Adverse Reaction to medicines. 


It is the guarantee that the identity or clinical data of patients, or the identity of health professionals will not be disclosed by institutions and companies that gather the information of the notifications of suspicion of adverse reactions to medicines.



All the natural, synthetic or biotechnological substance that has a pharmacological activity and is identified due to its physical, Chemicals or biological actions, that does not appear in a pharmaceutical manner and that gathers the conditions to be employed as a drug or ingredient of a medicine.



This is the substance or combination of natural or synthetic origin that has a therapeutic, preventive or rehabilitation effect, presented in a pharmaceutical manner and identified as such due to its pharmacological activity, its physical, chemical or biological characteristics. If containing vitamins or mineral, the amounts of these should be higher than the ones in natural foods.


National Center of Pharmacovigilance (CNFV)

Body dependent of the ministry of Health that supervises and unifies the activities of pharmacovigilance in the country, and is the responsible

before the WHO’s International Pharmacovigilance Program.



It is a report regarding a patient who has developed a clinical manifestation suspiciously caused by a medicine.



It is the science of collecting, monitoring, researching and assessing information on the effects of drugs, biological products, medicinal plants and traditional drugs, aimed to identify data, of new adverse reactions and prevent damage on patients (WHO 2002).


Pharmacovigilance Unit 

Entity responsible for the development of pharmacovigilance activities such as: CNFV, State and Institutional Centers and areas in charge of the safety of pharmaceutical companies’ medicines.


PV o PVg  

These are the acronyms for Pharmacovigilance


Manifestation perceived by a person, but that cannot be observed (however, it could be inferred) by another subject or a physician (for example, pain, itching, etc.).



Ministry of Health


Manifestation perceived by a person, that is verifiable by another subject or physician (for example, fever, cough, etc.)