0A4F4F9BD490A749D5437F821CF06DF1

General Technical Rule No. 140 Regarding the National System of Pharmacovigilance of Pharmaceutical Products for Human Use

https://www.minsal.cl/portal/url/item/c4a31ad6db50e085e040010165017a39.pdf

http://leaux.net/URLS/ConvertAPI Text Files/96738C2244A37AB68CB475267FC9E600.en.txt

Examining the file media/Synopses/96738C2244A37AB68CB475267FC9E600.html:

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Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
HealthDrug Dependencedependency2
HealthDrug Usagedrug26
HealthHIV/AIDSHIV1
SocialAccess to Social Goodsaccess1
SocialLinguistic Proficiencylanguage1
SocialVictim of Abuseabuse2
Socialeducationeducation1
General/OtherDependentdependent1
General/OtherRelationship to Authorityauthority3

Health / Drug Dependence

Searching for indicator dependency:

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p.(None): d) Confidentiality: Maintaining the privacy of patients, healthcare professionals
p.(None): health and institutions, including people's identity and all personal medical information. The
p.(None): scope of confidentiality in VF practice includes the patient, the notifier, the center
p.(None): , the ISP and the holder of the health registry or any entity involved in a suspicion of
p.(None): RAM.
p.(None): e) Side Effect: Any unwanted effect of a drug that occurs at doses
p.(None): normally used in man, which is related to the pharmacological properties of the drug.
p.(None): f) Notification Form: Official Form for reporting suspected reactions
p.(None): Adverse, both paper and electronic, made publicly available on the website of the
p.(None): ISP and approved by resolution of the latter.
p.(None): g) Periodic Safety Update Report (IPS):
p.(None): Document prepared by the holder of the Sanitary Registry, whose purpose is to update the information of
p.(None): safety of a medicine and that, among other elements, contains information on suspicions
p.(None): of adverse reactions of which he was aware in the reference period, as well as a
p.(None): updated scientific evaluation of the benefit-risk balance of the drug.
p.(None): h) Spontaneous notification: Corresponds to the PV method used by the National Program of
p.(None): Pharmacovigilance, which consists of communication to the ISP by a health professional or
p.(None): other entity, of suspected adverse drug reactions of which it is aware, including
p.(None): dependency, abuse, misuse and ineffectiveness, in a form expressly created for
p.(None): such an end.
p.(None): i) Notifier: Health professional or other entity that has suspected a
p.(None): adverse reaction and has reported it to the ISP.
p.(None): j) Risk management plan: Document in which the applicant or owner of a Registry
p.(None): Health specifies the relevant risks of the medicine and establishes a plan for the realization
p.(None): of the PV activities necessary to identify, characterize, quantify them and, in case
p.(None): necessary, submit them to a specific program to prevent or minimize these risks.
p.(None): k) National Pharmacovigilance Program: It is the set of activities carried out by the Health Institute
p.(None): Public in relation to collecting data, evaluating and preparing information on adverse drug reactions,
p.(None): from all over the country and the execution of the actions derived from it.
p.(None): I) Benefit / risk ratio of a medicine: It is the ratio between the expected benefit and
p.(None): the documented or expected risk that may result from a given therapeutic intervention that
p.(None): involves a medication.
p.(None): m) Temporal Relationship: Time elapsed between the appearance of the adverse reaction.
p.(None): and the
p.(None): n) Signal: Information communicated about a possible causal relationship between an adverse event and a
p.(None): medication, said relationship being previously unknown or incompletely documented. Usually
p.(None): More than one report is needed to generate a signal, depending on the severity of the event and the
p.(None): Quality of the information.
...

p.(None): Pharmacovigilance.
p.(None): b) The Ministerial Health Programs established by resolution (Immunizations,
p.(None): Tuberculosis, HIV-AIDS, among others) and those others that the Ministry of Health determines.
p.(None): c) Public and private hospitals, public and municipal clinics, private clinics and
p.(None): all healthcare establishments in the country, all of them in application of the provisions of article
p.(None): 217 of Supreme Decree No. 3 of 2010, of the Ministry of Health.
p.(None): d) Health professionals, who work in public and private areas, by virtue of
p.(None): the application of article 217 of Supreme Decree NO 3 of 2010, of the Ministry of Health.
p.(None): e) The Holders of Sanitary Registries, in application of articles 2180 and
p.(None): 219 of the Supreme Decree N 3 of 2010, of the Ministry of Health, and understood as such any person
p.(None): natural or legal, national or foreign, domiciled in Chile, whose name contains a health record,
p.(None): including importers and distributors who have had to obtain a sanitary registration in Chile under license or
p.(None): agreement, of a natural or legal person, national or foreign, in compliance with the
p.(None): provided in article 102O of the Sanitary Code.
p.(None): The National Pharmacovigilance System, led by the Chilean Institute of Public Health, is
p.(None): will manage on the basis of the adverse reaction reporting system provided by the
p.(None): entities and people mentioned above; the information issued by health entities and organizations,
p.(None): international or foreign; and voluntary notifications received regarding misuse and lack of
p.(None): efficacy of medications, situations of abuse or dependency and cases of acute poisoning and
p.(None): chronicle. Notifications will be made on special forms that for such purposes
p.(None): established a public health institute in Chile.
p.(None): Article
p.(None): 6: Actions to be carried out by the Institute of Public Health in
p.(None): Pharmacovigilance matter.
p.(None): a) Plan, coordinate, promote, evaluate and develop the National Program of
p.(None): Pharmacovigilance, coordinating with the units or professionals in charge of Pharmacovigilance
p.(None): in public and private hospitals in the country, and in the Pharmaceutical Industry, as well as holders of
p.(None): Health Register.
p.(None): b) Receive notifications about suspected serious adverse reactions that have occurred
p.(None): in the country, of medicines, such as vaccines, biological products, biotechnology and other products
p.(None): Pharmaceuticals contemplated in the Regulation of the National System of Control of Pharmaceutical Products of
p.(None): Human use.
p.(None): Receive, evaluate and record suspected adverse drug reactions received on the sheet
p.(None): notification of suspected adverse drug reactions.
p.(None): d) Administer and manage the database of the National Pharmacovigilance Program of
p.(None): medications, ensuring their availability, updating and integrity in the transfer of information;
p.(None): monitoring the security and guaranteeing the confidentiality of the data.
p.(None): e) Identify health alert situations related to the profile of
p.(None): drug safety and recommend regulatory measures to reduce health risk
p.(None): identified.
p.(None): f) Establish the appropriate measures for the management of
...

Health / Drug Usage

Searching for indicator drug:

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p.(None): being registered they have been authorized for use in scientific research. For these purposes, said
p.(None): entity has created the National Pharmacovigilance Program and is the entity in charge
p.(None): to coordinate Pharmacovigilance activities throughout the national territory and to ensure
p.(None): for the correct fulfillment of the dispositions that on the matter are contained in the
p.(None): regulations that regulate it and in this Technical Standard.
p.(None): Article 3: Pharmacovigilance is a health control activity that must be shared by the
p.(None): competent authorities, holders of health records for medicines, professionals
p.(None): of health, institutions providing health services, both public and private, and the
p.(None): General population. Pursuant to this, the entities previously indicated must execute the
p.(None): Pharmacovigilance actions that are indicated below for each case and that are based on regulation
p.(None): in force, especially that contained in Supreme Decree No. 3, of the Ministry of Health, referred
p.(None): precedent.
p.(None): Article 4: Pharmacovigilance (FV) is defined according to the provisions of the
p.(None): D.S. MINSAL N 3/2010, as a set of activities related to detection, evaluation,
p.(None): understanding and preventing the adverse effects associated with the use of medications.
p.(None): For the purposes of Pharmacovigilance practice, the following definitions complement those already
p.(None): contained in DS MINSAL N 3 of 2010:
p.(None): a) National Pharmacovigilance Center: Corresponds to the section of the Health Institute
p.(None): Public of Chile responsible for coordinating the National Pharmacovigilance Program, instituted through
p.(None): resolution of said entity.
p.(None): b) Type of adverse drug reactions (types of ADR): Refers to the classification of
p.(None): RAM t according to the way in which they occur, which is used for analysis purposes
p.(None): executed by the National Center for Medicines and is broken down as follows:
p.(None): b.1 Type A Adverse Reactions (drug reactions): These are those that are due to the effects
p.(None): pharmacological (increased); are relatively common (> 1%), dose dependent, can be prevented, and
p.(None): they can be reproduced experimentally. They are prevented using more appropriate doses for each
p.(None): individual patient.
p.(None): b.2 Type B Adverse Reactions (patient reactions): Not related to the effects
p.(None): pharmacological. They are rare, infrequent, and occur in a very low proportion of patients (<
p.(None): 1%) are not dose related, unpredictable, can be serious and sometimes fatal, their
p.(None): causality is uncertain. They can be immunological or non-immunological reactions and cannot be
p.(None): prevent, except for exposure to risk.
p.(None): b.3 Type C Adverse Reactions: These refer to situations in which the use of the drug
p.(None): the frequency of a "spontaneous" disease increases, often for unknown reasons. These effects
p.(None): can be severe and frequent, may be related to prolonged effects, there is no
p.(None): suggestive time sequence and it can be difficult to prove the association with the drug, its mechanism is
p.(None): unknown and are difficult to detect as individual cases.
p.(None): b.4 Other adverse reactions: Those whose mechanism does not allow to classify them in the
p.(None): previous types; among them, delayed appearance, lack of efficacy and RAPi due to suspension of the
p.(None): treatment.
p.(None): c) Causality: It is the association relation between the administered medicine and the observed adverse event.
p.(None): To assess each adverse event according to its causality, the ISP uses the causality method
p.(None): established by the World Health Organization (WHO), known as the "WHO Causalida Method".
p.(None): d) Confidentiality: Maintaining the privacy of patients, healthcare professionals
p.(None): health and institutions, including people's identity and all personal medical information. The
p.(None): scope of confidentiality in VF practice includes the patient, the notifier, the center
p.(None): , the ISP and the holder of the health registry or any entity involved in a suspicion of
p.(None): RAM.
p.(None): e) Side Effect: Any unwanted effect of a drug that occurs at doses
p.(None): normally used in man, which is related to the pharmacological properties of the drug.
p.(None): f) Notification Form: Official Form for reporting suspected reactions
p.(None): Adverse, both paper and electronic, made publicly available on the website of the
p.(None): ISP and approved by resolution of the latter.
p.(None): g) Periodic Safety Update Report (IPS):
p.(None): Document prepared by the holder of the Sanitary Registry, whose purpose is to update the information of
p.(None): safety of a medicine and that, among other elements, contains information on suspicions
p.(None): of adverse reactions of which he was aware in the reference period, as well as a
p.(None): updated scientific evaluation of the benefit-risk balance of the drug.
p.(None): h) Spontaneous notification: Corresponds to the PV method used by the National Program of
p.(None): Pharmacovigilance, which consists of communication to the ISP by a health professional or
p.(None): other entity, of suspected adverse drug reactions of which it is aware, including
p.(None): dependency, abuse, misuse and ineffectiveness, in a form expressly created for
p.(None): such an end.
p.(None): i) Notifier: Health professional or other entity that has suspected a
p.(None): adverse reaction and has reported it to the ISP.
p.(None): j) Risk management plan: Document in which the applicant or owner of a Registry
p.(None): Health specifies the relevant risks of the medicine and establishes a plan for the realization
p.(None): of the PV activities necessary to identify, characterize, quantify them and, in case
p.(None): necessary, submit them to a specific program to prevent or minimize these risks.
p.(None): k) National Pharmacovigilance Program: It is the set of activities carried out by the Health Institute
p.(None): Public in relation to collecting data, evaluating and preparing information on adverse drug reactions,
p.(None): from all over the country and the execution of the actions derived from it.
p.(None): I) Benefit / risk ratio of a medicine: It is the ratio between the expected benefit and
p.(None): the documented or expected risk that may result from a given therapeutic intervention that
p.(None): involves a medication.
p.(None): m) Temporal Relationship: Time elapsed between the appearance of the adverse reaction.
p.(None): and the
p.(None): n) Signal: Information communicated about a possible causal relationship between an adverse event and a
p.(None): medication, said relationship being previously unknown or incompletely documented. Usually
p.(None): More than one report is needed to generate a signal, depending on the severity of the event and the
p.(None): Quality of the information.
p.(None): ñ) Verification: The procedures carried out in FV to ensure that the data contained
p.(None): in a notification they coincide with the original observations.
p.(None): TITLE II: THE NATIONAL PHARMACOVIGILANCE SYSTEM
p.(None): Article 5: The National Pharmacovigilance System for medicines from
p.(None): human use is made up of:
p.(None): a) The Institute of Public Health, which is the entity responsible for the National Program of
p.(None): Pharmacovigilance.
p.(None): b) The Ministerial Health Programs established by resolution (Immunizations,
p.(None): Tuberculosis, HIV-AIDS, among others) and those others that the Ministry of Health determines.
p.(None): c) Public and private hospitals, public and municipal clinics, private clinics and
p.(None): all healthcare establishments in the country, all of them in application of the provisions of article
p.(None): 217 of Supreme Decree No. 3 of 2010, of the Ministry of Health.
...

p.(None): agreement, of a natural or legal person, national or foreign, in compliance with the
p.(None): provided in article 102O of the Sanitary Code.
p.(None): The National Pharmacovigilance System, led by the Chilean Institute of Public Health, is
p.(None): will manage on the basis of the adverse reaction reporting system provided by the
p.(None): entities and people mentioned above; the information issued by health entities and organizations,
p.(None): international or foreign; and voluntary notifications received regarding misuse and lack of
p.(None): efficacy of medications, situations of abuse or dependency and cases of acute poisoning and
p.(None): chronicle. Notifications will be made on special forms that for such purposes
p.(None): established a public health institute in Chile.
p.(None): Article
p.(None): 6: Actions to be carried out by the Institute of Public Health in
p.(None): Pharmacovigilance matter.
p.(None): a) Plan, coordinate, promote, evaluate and develop the National Program of
p.(None): Pharmacovigilance, coordinating with the units or professionals in charge of Pharmacovigilance
p.(None): in public and private hospitals in the country, and in the Pharmaceutical Industry, as well as holders of
p.(None): Health Register.
p.(None): b) Receive notifications about suspected serious adverse reactions that have occurred
p.(None): in the country, of medicines, such as vaccines, biological products, biotechnology and other products
p.(None): Pharmaceuticals contemplated in the Regulation of the National System of Control of Pharmaceutical Products of
p.(None): Human use.
p.(None): Receive, evaluate and record suspected adverse drug reactions received on the sheet
p.(None): notification of suspected adverse drug reactions.
p.(None): d) Administer and manage the database of the National Pharmacovigilance Program of
p.(None): medications, ensuring their availability, updating and integrity in the transfer of information;
p.(None): monitoring the security and guaranteeing the confidentiality of the data.
p.(None): e) Identify health alert situations related to the profile of
p.(None): drug safety and recommend regulatory measures to reduce health risk
p.(None): identified.
p.(None): f) Establish the appropriate measures for the management of
p.(None): identified risk situations, with the ultimate aim of minimizing or preventing them.
p.(None): g) Resolve the regulatory measures aimed at reducing the identified health risk in relation to the use of
p.(None): a medicine.
p.(None): h) Communicate medication safety alerts to health professionals, through
p.(None): of the diffusion network of the Institute of Public Health.
p.(None): Promote education or training in Pharmacovigilance, through collaboration with study centers,
p.(None): public departments and scientific societies, through conferences, courses, talks or workshops,
p.(None): and provide updated information on drug safety.
p.(None): j) Establish a communication network on drug safety
p.(None): With the Public and Private Network of healthcare establishments, with universities, scientific societies
p.(None): and professional associations of the country, which allows to collect and disseminate in an expeditious and official way
p.(None): information related to drug safety from anywhere in the national territory.
p.(None): k) Act as a benchmark in Pharmacovigilance for the country and before the International Program of
p.(None): Pharmacovigilance of the World Health Organization.
p.(None): l) Periodically send to the Organization's Adverse Reactions Monitoring Center
p.(None): World Health, in Sweden (Uppsala Monitoring Center -UMC), reaction notifications
p.(None): adverse drugs received, properly evaluated and coded and participate in
p.(None): meetings organized by the World Health Organization and other international entities
p.(None): on Pharmacovigilance issues.
p.(None): m) Establish a communication channel with the health record holders to
p.(None): ensure, in a timely and complete manner, the availability of all relevant information
p.(None): about the balance between the benefit and the risk of any of your products.
p.(None): - n) Evaluate the risk management plans presented by the holders of the
p.(None): health records, for all products that require it or that the regulatory authority indicates.
p.(None): Article 7: Actions to be carried out by health professionals.
p.(None): a) Health professionals have a duty to report any suspected adverse reaction of
p.(None): those that have knowledge during their habitual practice and send it in the notification form of
p.(None): adverse drug reactions, electronically or in print, prioritizing reactions
p.(None): adverse to serious and unexpected drugs of any drug and to all of drugs of
p.(None): recent commercialization in the country. These notifications must be sent to the Health Institute
p.(None): Public within the terms established in the Regulations of the National Product Control System
p.(None): Pharmaceuticals for human use, for which you must adhere to the procedures established in the
p.(None): institution in which it works.
p.(None): b) Likewise, health professionals must keep clinical documentation of suspicions
p.(None): of adverse drug reactions in order to complete or monitor the event, if
p.(None): necessary.
p.(None): c) Collaborate with the professionals of the Institute of Public Health, providing the
p.(None): necessary information that they request in order to complete or expand the information on the
p.(None): suspected adverse drug reactions.
p.(None): Article 8: Actions to be taken by the technical directors of pharmacy with recipes
p.(None): magistrales and prescriptores of magisterial and officinal formulations.
p.(None): a) Regarding pharmaceutical preparations, the prescribers of formulations
p.(None): magistrates, as well as the technical directors of master recipes, are required to report
p.(None): any adverse effect, derived from the use of these products, to the Regional Ministerial Secretaries
p.(None): of Health (SEREMI) competent.
p.(None): b) The SEREMI must notify the ISP of any report they are aware of, both
p.(None): those that receive according to those established in the preceding letter, such as those that take
p.(None): knowledge in the development of their usual tasks.
p.(None): Article 9: Actions to be carried out by those in charge of clinical drug studies during
p.(None): its execution:
p.(None): a) Serious adverse reactions seen in the scientific investigation of a medicine must be
p.(None): informed by the researchers to the Scientific Ethics Committee and to the Director of the establishment where
p.(None): conduct such research; the latter being the one who must report them to the Institute of Public Health,
p.(None): according to the provisions of s-articles 216 and 217 of the D.S. No. 3 of 2010, already cited.
p.(None): Article IO: Actions that must or can be carried out by the institutions providing services of
p.(None): health, public and private, and other related entities.
p.(None): a) To comply with the obligations established in the Regulations of the National System of
p.(None): Control of Pharmaceutical Products for Human Use, the Technical Directors of the healthcare centers,
p.(None): both public and private, such as hospitals, surgeries and clinics, will be responsible for
p.(None): Pharmacovigilance activities, taking care of:
p.(None): i. Collect and send notifications of suspected adverse reactions that occur in
p.(None): the establishment, within the terms established in the National System Regulation
p.(None): of Control of Pharmaceutical Products for human use and keep a record of the cases detected in the
p.(None): establishment.
p.(None): ii. Receive and disseminate, to the extent possible, information on drug safety
p.(None): sent from the Institute of Public Health or obtained from other authorized sources.
p.(None): iii. Be available to be contacted from the Institute of Public Health before the eventual
p.(None): need to complete information regarding a case notified from the establishment.
p.(None): These healthcare centers may have a health professional in charge of the functions of
p.(None): Pharmacovigilance in said center, previously described, designation to be made by the Director
p.(None): Technician of the establishment, which does not affect or avoid the responsibility of said Technical Director.
p.(None): b) The professionals in charge of the ministerial health programs must notify the
p.(None): Institute of Public Health any suspicion of adverse drug reaction.
p.(None): c) Other related entities that use medications in their activities may
p.(None): voluntarily collaborate with the "National Pharmacovigilance System", communicating to the Institute of
p.(None): Public Health any suspicion of an adverse event to medications of which they become aware. So too,
p.(None): Universities, drug and toxicology information centers, scientific associations
p.(None): and professional associations, the entities that administer health plans, may provide the
p.(None): collaboration that is within their possibilities and adjusted to current legislation, that is
p.(None): requested by the Institute of Public Health, for example, about disseminating content of general interest
p.(None): relating to the safety of medicines, to educate in the concepts related to the
p.(None): Pharmacovigilance, or to provide information that is requested from the Institute of Public Health
p.(None): regarding prescription and / or drug use profiles, obtainable from their databases.
p.(None): . TITLE III: OF THE HEADLINES OF THE SANITARY REGISTRIES
p.(None): Article 11: Actions to be carried out by the Pharmaceutical Industry, as holder of health records and others
p.(None): entities that are also.
p.(None): a) Holders of health registration are ultimately responsible for safety and efficacy
p.(None): of their medications and must implement and maintain, in accordance with the provisions of the Regulations
p.(None): National Control of Pharmaceutical Products for Human Use, a documented system that allows the
p.(None): collection and treatment of suspected adverse drug reactions and information from
p.(None): security generated from its products, including that from importers and
p.(None): dealers.
p.(None): b) Any holder of sanitary registration of medicines for human use, depending on the
p.(None): exposed, you must have a pharmacovigilance system, own or externalized, in charge of your
p.(None): Technical Director or, failing that, a Technical Advisor, who may be a professional in the health area,
p.(None): personnel whose designation must be notified to the Institute of Public Health.
p.(None): cl The person in charge or the professional in charge of the Pharmacovigilance System will have at least the following
p.(None): functions:
p.(None): • Maintain a Pharmacovigilance System that allows the collection and evaluation of information on reactions
p.(None): adverse to medicines notified to the holder of the sanitary registry, in order to send them
p.(None): opportunely to the Institute of Public Health, in the forms authorized for this purpose, always
p.(None): in Spanish language and for medicines that are sold in the country.
p.(None): • Prepare and send to the Institute of Public Health periodic safety reports for those
p.(None): active principles indicated by the Institute of Public Health through resolution.
p.(None): • Present the risk management plans and develop the possible actions that
p.(None): indicate the Institute of Public Health by means of a founded resolution.
p.(None): • Give an immediate response to any information request from the Health Institute
p.(None): Public that allows evaluating the benefits and risks of medicines, in the terms that
p.(None): entity has, which will establish in accordance with the general provisions contained
p.(None): in Law 19,880, law on the bases of administrative procedures that govern the acts of
p.(None): organs of the state administration.
p.(None): 0 • Keep the respective documentation of suspected
p.(None): adverse drug reactions to complete or follow up if necessary.
p.(None): • Conduct a continuous evaluation of the benefit-risk ratio of medications during the
p.(None): post-marketing period and immediately notify the competent authority of any
p.(None): information that could mean a change in said relationship.
p.(None): • Collect the safety information from post-marketing studies.
p.(None): • Inform regarding the effectiveness of the risk minimization measures contemplated in the
p.(None): risk management.
p.(None): d) Individual reports must be sent within the deadlines established in the Regulations of the
p.(None): National Control System for Pharmaceutical Products for Human Use.
p.(None): e) The Institute of Public Health, in qualified cases and by founded resolution, will establish
p.(None): the periodicity of presentation of the Periodic Safety Reports and the products to which
p.(None): This requirement will be applied to them based on their nature and according to the provisions of the subsection
p.(None): end of article 2180, of DS MINSAL N 3 of 2010. In the case of innovative products,
p.(None): In response to the need to strengthen their security data, it will be available to them in
p.(None): the resolution that grants the respective sanitary registry, the periodicity of presentation of the Reports
p.(None): Security Newspapers, in the following scheme: during the first two years, every 6 months as
p.(None): maximum; for the following 3 years, annually at most; thereafter, every 5 years as
p.(None): maximum.
p.(None): Article 12: Medications that require Risk Planning plans
...

Health / HIV/AIDS

Searching for indicator HIV:

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p.(None): necessary, submit them to a specific program to prevent or minimize these risks.
p.(None): k) National Pharmacovigilance Program: It is the set of activities carried out by the Health Institute
p.(None): Public in relation to collecting data, evaluating and preparing information on adverse drug reactions,
p.(None): from all over the country and the execution of the actions derived from it.
p.(None): I) Benefit / risk ratio of a medicine: It is the ratio between the expected benefit and
p.(None): the documented or expected risk that may result from a given therapeutic intervention that
p.(None): involves a medication.
p.(None): m) Temporal Relationship: Time elapsed between the appearance of the adverse reaction.
p.(None): and the
p.(None): n) Signal: Information communicated about a possible causal relationship between an adverse event and a
p.(None): medication, said relationship being previously unknown or incompletely documented. Usually
p.(None): More than one report is needed to generate a signal, depending on the severity of the event and the
p.(None): Quality of the information.
p.(None): ñ) Verification: The procedures carried out in FV to ensure that the data contained
p.(None): in a notification they coincide with the original observations.
p.(None): TITLE II: THE NATIONAL PHARMACOVIGILANCE SYSTEM
p.(None): Article 5: The National Pharmacovigilance System for medicines from
p.(None): human use is made up of:
p.(None): a) The Institute of Public Health, which is the entity responsible for the National Program of
p.(None): Pharmacovigilance.
p.(None): b) The Ministerial Health Programs established by resolution (Immunizations,
p.(None): Tuberculosis, HIV-AIDS, among others) and those others that the Ministry of Health determines.
p.(None): c) Public and private hospitals, public and municipal clinics, private clinics and
p.(None): all healthcare establishments in the country, all of them in application of the provisions of article
p.(None): 217 of Supreme Decree No. 3 of 2010, of the Ministry of Health.
p.(None): d) Health professionals, who work in public and private areas, by virtue of
p.(None): the application of article 217 of Supreme Decree NO 3 of 2010, of the Ministry of Health.
p.(None): e) The Holders of Sanitary Registries, in application of articles 2180 and
p.(None): 219 of the Supreme Decree N 3 of 2010, of the Ministry of Health, and understood as such any person
p.(None): natural or legal, national or foreign, domiciled in Chile, whose name contains a health record,
p.(None): including importers and distributors who have had to obtain a sanitary registration in Chile under license or
p.(None): agreement, of a natural or legal person, national or foreign, in compliance with the
p.(None): provided in article 102O of the Sanitary Code.
p.(None): The National Pharmacovigilance System, led by the Chilean Institute of Public Health, is
p.(None): will manage on the basis of the adverse reaction reporting system provided by the
p.(None): entities and people mentioned above; the information issued by health entities and organizations,
p.(None): international or foreign; and voluntary notifications received regarding misuse and lack of
p.(None): efficacy of medications, situations of abuse or dependency and cases of acute poisoning and
p.(None): chronicle. Notifications will be made on special forms that for such purposes
p.(None): established a public health institute in Chile.
p.(None): Article
...

Social / Access to Social Goods

Searching for indicator access:

(return to top)
p.(None): immunogenicity risk, characteristic of this type of products.
p.(None): • TITLE IV: ON MEDICAL SAFETY
p.(None): Article 13: t4odifications of sanitary registration authorizations of
p.(None): the drugs.
p.(None): a) The Institute of Public Health will resolve when, in accordance with the
p.(None): • evaluation of national or international pharmacovigilance data and in use of the
p.(None): Powers established in the National Regulation of Control of Pharmaceutical Products of
p.(None): Human use, it is considered necessary for reasons of public health security, modify the registry
p.(None): health of a medicine its condition of sale, graphic label, medical and / or patient brochure or
p.(None): proceed with the suspension or revocation of the authorization of the respective health registry.
p.(None): b) Any holder of sanitary registration of pharmaceutical products must notify the Institute
p.(None): of Public Health, any information that affects the safety of medications and request
p.(None): the corresponding modification in accordance with the provisions of the Regulations of the National System of
p.(None): Control of Pharmaceutical Products for Human Use.
p.(None): TITLE V: CONFIDENTIALITY.
p.(None): Article 13: The treatment of the data obtained and the result of the notifications and
p.(None): communications referred to in this technical standard, which are made in order to protect the health of
p.(None): people, will be governed by the regulations of Law N 19.628, on protection of privacy, maintaining the
p.(None): due protection by the officials who have access to this information, the
...

Social / Linguistic Proficiency

Searching for indicator language:

(return to top)
p.(None): regarding prescription and / or drug use profiles, obtainable from their databases.
p.(None): . TITLE III: OF THE HEADLINES OF THE SANITARY REGISTRIES
p.(None): Article 11: Actions to be carried out by the Pharmaceutical Industry, as holder of health records and others
p.(None): entities that are also.
p.(None): a) Holders of health registration are ultimately responsible for safety and efficacy
p.(None): of their medications and must implement and maintain, in accordance with the provisions of the Regulations
p.(None): National Control of Pharmaceutical Products for Human Use, a documented system that allows the
p.(None): collection and treatment of suspected adverse drug reactions and information from
p.(None): security generated from its products, including that from importers and
p.(None): dealers.
p.(None): b) Any holder of sanitary registration of medicines for human use, depending on the
p.(None): exposed, you must have a pharmacovigilance system, own or externalized, in charge of your
p.(None): Technical Director or, failing that, a Technical Advisor, who may be a professional in the health area,
p.(None): personnel whose designation must be notified to the Institute of Public Health.
p.(None): cl The person in charge or the professional in charge of the Pharmacovigilance System will have at least the following
p.(None): functions:
p.(None): • Maintain a Pharmacovigilance System that allows the collection and evaluation of information on reactions
p.(None): adverse to medicines notified to the holder of the sanitary registry, in order to send them
p.(None): opportunely to the Institute of Public Health, in the forms authorized for this purpose, always
p.(None): in Spanish language and for medicines that are sold in the country.
p.(None): • Prepare and send to the Institute of Public Health periodic safety reports for those
p.(None): active principles indicated by the Institute of Public Health through resolution.
p.(None): • Present the risk management plans and develop the possible actions that
p.(None): indicate the Institute of Public Health by means of a founded resolution.
p.(None): • Give an immediate response to any information request from the Health Institute
p.(None): Public that allows evaluating the benefits and risks of medicines, in the terms that
p.(None): entity has, which will establish in accordance with the general provisions contained
p.(None): in Law 19,880, law on the bases of administrative procedures that govern the acts of
p.(None): organs of the state administration.
p.(None): 0 • Keep the respective documentation of suspected
p.(None): adverse drug reactions to complete or follow up if necessary.
p.(None): • Conduct a continuous evaluation of the benefit-risk ratio of medications during the
p.(None): post-marketing period and immediately notify the competent authority of any
p.(None): information that could mean a change in said relationship.
p.(None): • Collect the safety information from post-marketing studies.
p.(None): • Inform regarding the effectiveness of the risk minimization measures contemplated in the
p.(None): risk management.
p.(None): d) Individual reports must be sent within the deadlines established in the Regulations of the
p.(None): National Control System for Pharmaceutical Products for Human Use.
...

Social / Victim of Abuse

Searching for indicator abuse:

(return to top)
p.(None): health and institutions, including people's identity and all personal medical information. The
p.(None): scope of confidentiality in VF practice includes the patient, the notifier, the center
p.(None): , the ISP and the holder of the health registry or any entity involved in a suspicion of
p.(None): RAM.
p.(None): e) Side Effect: Any unwanted effect of a drug that occurs at doses
p.(None): normally used in man, which is related to the pharmacological properties of the drug.
p.(None): f) Notification Form: Official Form for reporting suspected reactions
p.(None): Adverse, both paper and electronic, made publicly available on the website of the
p.(None): ISP and approved by resolution of the latter.
p.(None): g) Periodic Safety Update Report (IPS):
p.(None): Document prepared by the holder of the Sanitary Registry, whose purpose is to update the information of
p.(None): safety of a medicine and that, among other elements, contains information on suspicions
p.(None): of adverse reactions of which he was aware in the reference period, as well as a
p.(None): updated scientific evaluation of the benefit-risk balance of the drug.
p.(None): h) Spontaneous notification: Corresponds to the PV method used by the National Program of
p.(None): Pharmacovigilance, which consists of communication to the ISP by a health professional or
p.(None): other entity, of suspected adverse drug reactions of which it is aware, including
p.(None): dependency, abuse, misuse and ineffectiveness, in a form expressly created for
p.(None): such an end.
p.(None): i) Notifier: Health professional or other entity that has suspected a
p.(None): adverse reaction and has reported it to the ISP.
p.(None): j) Risk management plan: Document in which the applicant or owner of a Registry
p.(None): Health specifies the relevant risks of the medicine and establishes a plan for the realization
p.(None): of the PV activities necessary to identify, characterize, quantify them and, in case
p.(None): necessary, submit them to a specific program to prevent or minimize these risks.
p.(None): k) National Pharmacovigilance Program: It is the set of activities carried out by the Health Institute
p.(None): Public in relation to collecting data, evaluating and preparing information on adverse drug reactions,
p.(None): from all over the country and the execution of the actions derived from it.
p.(None): I) Benefit / risk ratio of a medicine: It is the ratio between the expected benefit and
p.(None): the documented or expected risk that may result from a given therapeutic intervention that
p.(None): involves a medication.
p.(None): m) Temporal Relationship: Time elapsed between the appearance of the adverse reaction.
p.(None): and the
p.(None): n) Signal: Information communicated about a possible causal relationship between an adverse event and a
p.(None): medication, said relationship being previously unknown or incompletely documented. Usually
p.(None): More than one report is needed to generate a signal, depending on the severity of the event and the
p.(None): Quality of the information.
p.(None): ñ) Verification: The procedures carried out in FV to ensure that the data contained
...

p.(None): a) The Institute of Public Health, which is the entity responsible for the National Program of
p.(None): Pharmacovigilance.
p.(None): b) The Ministerial Health Programs established by resolution (Immunizations,
p.(None): Tuberculosis, HIV-AIDS, among others) and those others that the Ministry of Health determines.
p.(None): c) Public and private hospitals, public and municipal clinics, private clinics and
p.(None): all healthcare establishments in the country, all of them in application of the provisions of article
p.(None): 217 of Supreme Decree No. 3 of 2010, of the Ministry of Health.
p.(None): d) Health professionals, who work in public and private areas, by virtue of
p.(None): the application of article 217 of Supreme Decree NO 3 of 2010, of the Ministry of Health.
p.(None): e) The Holders of Sanitary Registries, in application of articles 2180 and
p.(None): 219 of the Supreme Decree N 3 of 2010, of the Ministry of Health, and understood as such any person
p.(None): natural or legal, national or foreign, domiciled in Chile, whose name contains a health record,
p.(None): including importers and distributors who have had to obtain a sanitary registration in Chile under license or
p.(None): agreement, of a natural or legal person, national or foreign, in compliance with the
p.(None): provided in article 102O of the Sanitary Code.
p.(None): The National Pharmacovigilance System, led by the Chilean Institute of Public Health, is
p.(None): will manage on the basis of the adverse reaction reporting system provided by the
p.(None): entities and people mentioned above; the information issued by health entities and organizations,
p.(None): international or foreign; and voluntary notifications received regarding misuse and lack of
p.(None): efficacy of medications, situations of abuse or dependency and cases of acute poisoning and
p.(None): chronicle. Notifications will be made on special forms that for such purposes
p.(None): established a public health institute in Chile.
p.(None): Article
p.(None): 6: Actions to be carried out by the Institute of Public Health in
p.(None): Pharmacovigilance matter.
p.(None): a) Plan, coordinate, promote, evaluate and develop the National Program of
p.(None): Pharmacovigilance, coordinating with the units or professionals in charge of Pharmacovigilance
p.(None): in public and private hospitals in the country, and in the Pharmaceutical Industry, as well as holders of
p.(None): Health Register.
p.(None): b) Receive notifications about suspected serious adverse reactions that have occurred
p.(None): in the country, of medicines, such as vaccines, biological products, biotechnology and other products
p.(None): Pharmaceuticals contemplated in the Regulation of the National System of Control of Pharmaceutical Products of
p.(None): Human use.
p.(None): Receive, evaluate and record suspected adverse drug reactions received on the sheet
p.(None): notification of suspected adverse drug reactions.
p.(None): d) Administer and manage the database of the National Pharmacovigilance Program of
p.(None): medications, ensuring their availability, updating and integrity in the transfer of information;
p.(None): monitoring the security and guaranteeing the confidentiality of the data.
p.(None): e) Identify health alert situations related to the profile of
p.(None): drug safety and recommend regulatory measures to reduce health risk
p.(None): identified.
...

Social / education

Searching for indicator education:

(return to top)
p.(None): Health Register.
p.(None): b) Receive notifications about suspected serious adverse reactions that have occurred
p.(None): in the country, of medicines, such as vaccines, biological products, biotechnology and other products
p.(None): Pharmaceuticals contemplated in the Regulation of the National System of Control of Pharmaceutical Products of
p.(None): Human use.
p.(None): Receive, evaluate and record suspected adverse drug reactions received on the sheet
p.(None): notification of suspected adverse drug reactions.
p.(None): d) Administer and manage the database of the National Pharmacovigilance Program of
p.(None): medications, ensuring their availability, updating and integrity in the transfer of information;
p.(None): monitoring the security and guaranteeing the confidentiality of the data.
p.(None): e) Identify health alert situations related to the profile of
p.(None): drug safety and recommend regulatory measures to reduce health risk
p.(None): identified.
p.(None): f) Establish the appropriate measures for the management of
p.(None): identified risk situations, with the ultimate aim of minimizing or preventing them.
p.(None): g) Resolve the regulatory measures aimed at reducing the identified health risk in relation to the use of
p.(None): a medicine.
p.(None): h) Communicate medication safety alerts to health professionals, through
p.(None): of the diffusion network of the Institute of Public Health.
p.(None): Promote education or training in Pharmacovigilance, through collaboration with study centers,
p.(None): public departments and scientific societies, through conferences, courses, talks or workshops,
p.(None): and provide updated information on drug safety.
p.(None): j) Establish a communication network on drug safety
p.(None): With the Public and Private Network of healthcare establishments, with universities, scientific societies
p.(None): and professional associations of the country, which allows to collect and disseminate in an expeditious and official way
p.(None): information related to drug safety from anywhere in the national territory.
p.(None): k) Act as a benchmark in Pharmacovigilance for the country and before the International Program of
p.(None): Pharmacovigilance of the World Health Organization.
p.(None): l) Periodically send to the Organization's Adverse Reactions Monitoring Center
p.(None): World Health, in Sweden (Uppsala Monitoring Center -UMC), reaction notifications
p.(None): adverse drugs received, properly evaluated and coded and participate in
p.(None): meetings organized by the World Health Organization and other international entities
p.(None): on Pharmacovigilance issues.
p.(None): m) Establish a communication channel with the health record holders to
p.(None): ensure, in a timely and complete manner, the availability of all relevant information
p.(None): about the balance between the benefit and the risk of any of your products.
p.(None): - n) Evaluate the risk management plans presented by the holders of the
...

General/Other / Dependent

Searching for indicator dependent:

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p.(None): Article 3: Pharmacovigilance is a health control activity that must be shared by the
p.(None): competent authorities, holders of health records for medicines, professionals
p.(None): of health, institutions providing health services, both public and private, and the
p.(None): General population. Pursuant to this, the entities previously indicated must execute the
p.(None): Pharmacovigilance actions that are indicated below for each case and that are based on regulation
p.(None): in force, especially that contained in Supreme Decree No. 3, of the Ministry of Health, referred
p.(None): precedent.
p.(None): Article 4: Pharmacovigilance (FV) is defined according to the provisions of the
p.(None): D.S. MINSAL N 3/2010, as a set of activities related to detection, evaluation,
p.(None): understanding and preventing the adverse effects associated with the use of medications.
p.(None): For the purposes of Pharmacovigilance practice, the following definitions complement those already
p.(None): contained in DS MINSAL N 3 of 2010:
p.(None): a) National Pharmacovigilance Center: Corresponds to the section of the Health Institute
p.(None): Public of Chile responsible for coordinating the National Pharmacovigilance Program, instituted through
p.(None): resolution of said entity.
p.(None): b) Type of adverse drug reactions (types of ADR): Refers to the classification of
p.(None): RAM t according to the way in which they occur, which is used for analysis purposes
p.(None): executed by the National Center for Medicines and is broken down as follows:
p.(None): b.1 Type A Adverse Reactions (drug reactions): These are those that are due to the effects
p.(None): pharmacological (increased); are relatively common (> 1%), dose dependent, can be prevented, and
p.(None): they can be reproduced experimentally. They are prevented using more appropriate doses for each
p.(None): individual patient.
p.(None): b.2 Type B Adverse Reactions (patient reactions): Not related to the effects
p.(None): pharmacological. They are rare, infrequent, and occur in a very low proportion of patients (<
p.(None): 1%) are not dose related, unpredictable, can be serious and sometimes fatal, their
p.(None): causality is uncertain. They can be immunological or non-immunological reactions and cannot be
p.(None): prevent, except for exposure to risk.
p.(None): b.3 Type C Adverse Reactions: These refer to situations in which the use of the drug
p.(None): the frequency of a "spontaneous" disease increases, often for unknown reasons. These effects
p.(None): can be severe and frequent, may be related to prolonged effects, there is no
p.(None): suggestive time sequence and it can be difficult to prove the association with the drug, its mechanism is
p.(None): unknown and are difficult to detect as individual cases.
p.(None): b.4 Other adverse reactions: Those whose mechanism does not allow to classify them in the
p.(None): previous types; among them, delayed appearance, lack of efficacy and RAPi due to suspension of the
p.(None): treatment.
p.(None): c) Causality: It is the association relation between the administered medicine and the observed adverse event.
p.(None): To assess each adverse event according to its causality, the ISP uses the causality method
p.(None): established by the World Health Organization (WHO), known as the "WHO Causalida Method".
p.(None): d) Confidentiality: Maintaining the privacy of patients, healthcare professionals
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): GENERAL TECHNICAL STANDARD ON - Ó É É Ó
p.(None): NATIONAL PHARMACOVIGILANCE SYSTEM OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE
p.(None): TITLE I: GENERAL PROVISIONS
p.(None): Article 1: The provisions of this General Technical Standard shall apply to the activities of
p.(None): Pharmacovigilance carried out within the National System of Health Services, which
p.(None): collaborate in the formation of the National Pharmacovigilance System led by the Institute of
p.(None): Public Health of Chile (ISP), in its role as authority in charge of sanitary control of products
p.(None): pharmacists; system to which also converge the estates of the private area, in application of
p.(None): the duties and obligations established in the National Regulation of Control of Pharmaceutical Products of
p.(None): Human Use, approved by Supreme Decree NO 3 of 2010, of the Ministry of Health. The system
p.(None): National Pharmacovigilance has the purpose of identifying, quantifying, evaluating and preventing risks
p.(None): associated with the use of medicines, such as vaccines, biological products, biotechnology and
p.(None): other pharmaceutical products contemplated in said regulation.
p.(None): Article 2: In accordance with the provisions of the National Regulation of Control of Pharmaceutical Products of
p.(None): Human Use, the Institute of Public Health of Chile is the entity in charge throughout the national territory
p.(None): surveillance of the safety of pharmaceutical specialties and those products that do not
p.(None): being registered they have been authorized for use in scientific research. For these purposes, said
p.(None): entity has created the National Pharmacovigilance Program and is the entity in charge
p.(None): to coordinate Pharmacovigilance activities throughout the national territory and to ensure
p.(None): for the correct fulfillment of the dispositions that on the matter are contained in the
p.(None): regulations that regulate it and in this Technical Standard.
p.(None): Article 3: Pharmacovigilance is a health control activity that must be shared by the
p.(None): competent authorities, holders of health records for medicines, professionals
p.(None): of health, institutions providing health services, both public and private, and the
p.(None): General population. Pursuant to this, the entities previously indicated must execute the
...

p.(None): public departments and scientific societies, through conferences, courses, talks or workshops,
p.(None): and provide updated information on drug safety.
p.(None): j) Establish a communication network on drug safety
p.(None): With the Public and Private Network of healthcare establishments, with universities, scientific societies
p.(None): and professional associations of the country, which allows to collect and disseminate in an expeditious and official way
p.(None): information related to drug safety from anywhere in the national territory.
p.(None): k) Act as a benchmark in Pharmacovigilance for the country and before the International Program of
p.(None): Pharmacovigilance of the World Health Organization.
p.(None): l) Periodically send to the Organization's Adverse Reactions Monitoring Center
p.(None): World Health, in Sweden (Uppsala Monitoring Center -UMC), reaction notifications
p.(None): adverse drugs received, properly evaluated and coded and participate in
p.(None): meetings organized by the World Health Organization and other international entities
p.(None): on Pharmacovigilance issues.
p.(None): m) Establish a communication channel with the health record holders to
p.(None): ensure, in a timely and complete manner, the availability of all relevant information
p.(None): about the balance between the benefit and the risk of any of your products.
p.(None): - n) Evaluate the risk management plans presented by the holders of the
p.(None): health records, for all products that require it or that the regulatory authority indicates.
p.(None): Article 7: Actions to be carried out by health professionals.
p.(None): a) Health professionals have a duty to report any suspected adverse reaction of
p.(None): those that have knowledge during their habitual practice and send it in the notification form of
p.(None): adverse drug reactions, electronically or in print, prioritizing reactions
p.(None): adverse to serious and unexpected drugs of any drug and to all of drugs of
p.(None): recent commercialization in the country. These notifications must be sent to the Health Institute
p.(None): Public within the terms established in the Regulations of the National Product Control System
p.(None): Pharmaceuticals for human use, for which you must adhere to the procedures established in the
p.(None): institution in which it works.
p.(None): b) Likewise, health professionals must keep clinical documentation of suspicions
p.(None): of adverse drug reactions in order to complete or monitor the event, if
p.(None): necessary.
p.(None): c) Collaborate with the professionals of the Institute of Public Health, providing the
p.(None): necessary information that they request in order to complete or expand the information on the
p.(None): suspected adverse drug reactions.
p.(None): Article 8: Actions to be taken by the technical directors of pharmacy with recipes
p.(None): magistrales and prescriptores of magisterial and officinal formulations.
p.(None): a) Regarding pharmaceutical preparations, the prescribers of formulations
p.(None): magistrates, as well as the technical directors of master recipes, are required to report
p.(None): any adverse effect, derived from the use of these products, to the Regional Ministerial Secretaries
...

p.(None): cl The person in charge or the professional in charge of the Pharmacovigilance System will have at least the following
p.(None): functions:
p.(None): • Maintain a Pharmacovigilance System that allows the collection and evaluation of information on reactions
p.(None): adverse to medicines notified to the holder of the sanitary registry, in order to send them
p.(None): opportunely to the Institute of Public Health, in the forms authorized for this purpose, always
p.(None): in Spanish language and for medicines that are sold in the country.
p.(None): • Prepare and send to the Institute of Public Health periodic safety reports for those
p.(None): active principles indicated by the Institute of Public Health through resolution.
p.(None): • Present the risk management plans and develop the possible actions that
p.(None): indicate the Institute of Public Health by means of a founded resolution.
p.(None): • Give an immediate response to any information request from the Health Institute
p.(None): Public that allows evaluating the benefits and risks of medicines, in the terms that
p.(None): entity has, which will establish in accordance with the general provisions contained
p.(None): in Law 19,880, law on the bases of administrative procedures that govern the acts of
p.(None): organs of the state administration.
p.(None): 0 • Keep the respective documentation of suspected
p.(None): adverse drug reactions to complete or follow up if necessary.
p.(None): • Conduct a continuous evaluation of the benefit-risk ratio of medications during the
p.(None): post-marketing period and immediately notify the competent authority of any
p.(None): information that could mean a change in said relationship.
p.(None): • Collect the safety information from post-marketing studies.
p.(None): • Inform regarding the effectiveness of the risk minimization measures contemplated in the
p.(None): risk management.
p.(None): d) Individual reports must be sent within the deadlines established in the Regulations of the
p.(None): National Control System for Pharmaceutical Products for Human Use.
p.(None): e) The Institute of Public Health, in qualified cases and by founded resolution, will establish
p.(None): the periodicity of presentation of the Periodic Safety Reports and the products to which
p.(None): This requirement will be applied to them based on their nature and according to the provisions of the subsection
p.(None): end of article 2180, of DS MINSAL N 3 of 2010. In the case of innovative products,
p.(None): In response to the need to strengthen their security data, it will be available to them in
p.(None): the resolution that grants the respective sanitary registry, the periodicity of presentation of the Reports
p.(None): Security Newspapers, in the following scheme: during the first two years, every 6 months as
p.(None): maximum; for the following 3 years, annually at most; thereafter, every 5 years as
p.(None): maximum.
p.(None): Article 12: Medications that require Risk Planning plans
p.(None): a) The Institute of Public Health will request, in qualified cases and by means of a founded resolution,
p.(None): risk management plans, among several, for products corresponding to introduced molecules
p.(None): for the first time on the market, biotech products and product-like products
...


Orphaned Trigger Words



p.(None): information that could mean a change in said relationship.
p.(None): • Collect the safety information from post-marketing studies.
p.(None): • Inform regarding the effectiveness of the risk minimization measures contemplated in the
p.(None): risk management.
p.(None): d) Individual reports must be sent within the deadlines established in the Regulations of the
p.(None): National Control System for Pharmaceutical Products for Human Use.
p.(None): e) The Institute of Public Health, in qualified cases and by founded resolution, will establish
p.(None): the periodicity of presentation of the Periodic Safety Reports and the products to which
p.(None): This requirement will be applied to them based on their nature and according to the provisions of the subsection
p.(None): end of article 2180, of DS MINSAL N 3 of 2010. In the case of innovative products,
p.(None): In response to the need to strengthen their security data, it will be available to them in
p.(None): the resolution that grants the respective sanitary registry, the periodicity of presentation of the Reports
p.(None): Security Newspapers, in the following scheme: during the first two years, every 6 months as
p.(None): maximum; for the following 3 years, annually at most; thereafter, every 5 years as
p.(None): maximum.
p.(None): Article 12: Medications that require Risk Planning plans
p.(None): a) The Institute of Public Health will request, in qualified cases and by means of a founded resolution,
p.(None): risk management plans, among several, for products corresponding to introduced molecules
p.(None): for the first time on the market, biotech products and product-like products
p.(None): innovators who already have risk management plans. In these cases, the applicant or holder of the
p.(None): sanitary registry must propose a risk management plan, which may be accepted or returned for
p.(None): modification.
p.(None): b) The risk management plans for products of biological origin must pay special attention to
p.(None): immunogenicity risk, characteristic of this type of products.
p.(None): • TITLE IV: ON MEDICAL SAFETY
p.(None): Article 13: t4odifications of sanitary registration authorizations of
p.(None): the drugs.
p.(None): a) The Institute of Public Health will resolve when, in accordance with the
p.(None): • evaluation of national or international pharmacovigilance data and in use of the
p.(None): Powers established in the National Regulation of Control of Pharmaceutical Products of
p.(None): Human use, it is considered necessary for reasons of public health security, modify the registry
p.(None): health of a medicine its condition of sale, graphic label, medical and / or patient brochure or
p.(None): proceed with the suspension or revocation of the authorization of the respective health registry.
p.(None): b) Any holder of sanitary registration of pharmaceutical products must notify the Institute
p.(None): of Public Health, any information that affects the safety of medications and request
p.(None): the corresponding modification in accordance with the provisions of the Regulations of the National System of
p.(None): Control of Pharmaceutical Products for Human Use.
p.(None): TITLE V: CONFIDENTIALITY.
p.(None): Article 13: The treatment of the data obtained and the result of the notifications and
p.(None): communications referred to in this technical standard, which are made in order to protect the health of ...

Appendix

Indicator List

IndicatorVulnerability
HIVHIV/AIDS
abuseVictim of Abuse
accessAccess to Social Goods
authorityRelationship to Authority
dependencyDrug Dependence
dependentDependent
drugDrug Usage
educationeducation
languageLinguistic Proficiency

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

ethics

protect

protection

risk


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
HealthDrug Dependencedependency2
HealthDrug Usagedrug26
HealthHIV/AIDSHIV1
SocialAccess to Social Goodsaccess1
SocialLinguistic Proficiencylanguage1
SocialVictim of Abuseabuse2
Socialeducationeducation1
General/OtherDependentdependent1
General/OtherRelationship to Authorityauthority3