It is the science and activity related to the detection, evaluation, understanding, and prevention of adverse drug effects or any potential drug-related problems.

It is any unintended harmful reaction that occurs after the use of a drug or pharmaceutical product in humans for prophylaxis, diagnosis, treatment, or to modify physiological functions.

It is a reaction that presents with easily tolerated signs and symptoms. It does not require treatment or prolong hospitalization and may or may not require discontinuation of the pharmaceutical product. It is considered a non-serious reaction.

It is a reaction that interferes with activities without directly threatening the patient’s life. It requires pharmacological treatment and may or may not require discontinuation of the pharmaceutical product causing the adverse reaction, it is considered a non-serious reaction.

It is any medical occurrence that has occurred at the time of administration of any dose of a pharmaceutical product, resulting in one or more of the following:

• When the drug causes the death of the patient or puts him/her in danger.
• When the drug threatens the patient’s life.
• When the drug causes the patient to be hospitalized.
• When the drug extends the patient’s hospital stay.
• When the drug causes disability or incapacity to the patient.
• When the medication causes alterations or malformations in the fetus and is observed in the newborn.
• When the drug administered has directly or indirectly contributed to the death of the patient.

Any occurrence that may occur during the use of a pharmaceutical product, medical device or medical product but does not necessarily have a causal relationship with such use.

It is any unintended event that causes harm to the patient, user, operator or others, or poses a risk of harm, which may or may not be causally associated with one or more medical devices. It is related to the identity, quality, durability and safety of these. It includes errors, preventable adverse events and risks.

An incident that does not change the quality of life of the affected person or their normal daily activities. It is considered a non-serious incident.

An incident that modifies the affected person’s normal daily activities (temporary disability). It is considered a non-serious incident.

An incident that causes one or more of the following:

• Threatens the life or causes the death of the patient.
• Makes it necessary to hospitalize or prolong the hospital stay.
• Causes permanent or significant disability or incapacity.
• Causes fetal disturbance, risk or death.
• Congenital anomalous cause.

It is any undesirable clinical manifestation that gives the indication or appearance of having a causal relationship with one or more pharmaceutical products.

They are pharmaceutical products containing a biological substance, obtained from microorganisms, blood or other tissues, whose manufacturing methods may include one or more of the following elements:

• Growth of a group of microorganisms, on different types of substrates.
• Use of eukaryotic cells.
• Extraction of substances from biological tissues, including human, animal and plant.
• Products obtained by recombinant DNA or hybridomas.
• Propagation of microorganisms in embryos or animals, among others.