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
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:
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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:
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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
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| authority | Relationship to Authority |
| dependency | Drug Dependence |
| dependent | Dependent |
| drug | Drug Usage |
| education | education |
| language | Linguistic Proficiency |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input