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INDICATORS

Exchange rate and rates to11/08/2017

Standard Oficial Mexicana NOM-220-SSA1-2016, installation and operation of pharmacovigilance.

Outside a seal with the coat of arms, which says: United States Mexicans-Ministry of health.

JULIO SALVADOR SÁNCHEZ Y TEPOZ, Federal Commissioner for the protection against risks Health and Chairman of theNational Advisory Committee for the standardization of regulation and health promotion, based on the provisions of the 39 articlesof the law organic of the Federal public administration; 4 of the Federal law on administrative procedure, 3rd. , fraction XXIV, 13,paragraph A, fractions I and IX, 17 Bis, subparagraph III, 58, fractions V Bis and VII, 107, 194, 195, 221, 222, 222 Bis, Bis 224,224 Bis 1 and 231 of the law General of health; 38, fraction II, 40, fractions I, XI, and XII, 41, 43 and 47, section IV of the aboveFederal law metrology and standardisation; 28 of the regulation of the Federal law on metrology and standardisation; 38 81 bis,131, 177, fraction IX and 190 Bis 1, fraction V of the regulation of inputs for health; 2, paragraph C, fraction X and 36 of the Interiorregulation of the health secretariat and 3, fractions I, subparagraph (b) and II, 10, fractions IV and VIII of the regulation of theCommission Federal for the protection against risk health, and

WHEREAS

With date of September 23, 2016, in compliance with the agreement of the National Advisory Committee of standardization ofregulation and health promotion and the provisions of article 47, section I of the Act Federal metrology and standardization, waspublished in the official journal of the Federation project of the this standard to that effect within sixty calendar days after suchpublication, the interested parties submit their comments to the Committee;

It was published in the official journal of the Federation, the response to comments previous, dated received by the Committee,in accordance with article 47, subparagraph III of the above Federal law metrology and standardization, and

That in view of the above considerations, with the approval of the Advisory Committee National standardization of regulationand health promotion, I have to either issue and order the publication in the official journal of the Federation of the:

NORMA OFICIAL MEXICANA NOM-220-SSA1-2016, installation and operation Of thePHARMACOVIGILANCE

PREFACE

The following dependencies, institutions participated in the elaboration of this standard and bodies:

SECRETARY OF HEALTH

Commission for protection against health risks Federal

Directorate-General of epidemiology

National Center for the health of children and adolescents

GENERAL HEALTH ADVICE

Interinstitutional Committee on the basic box and catalog of Health Sector inputs

INSTITUTO NACIONAL DE CANCEROLOGÍA

HOSPITAL INFANTIL DE MEXICO FEDERICO GOMEZ

MEXICAN INSTITUTE OF SOCIAL SECURITY

Coordination of the institutional program of pharmacovigilance

Quality of the Hospital's Oncology Division

Coordination of health services

UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO

Faculty of chemistry

Faculty of medicine

INSTITUTO POLITÉCNICO NACIONAL

Center for research and advanced studies

National School of biological sciences

BENEMÉRITA UNIVERSIDAD AUTÓNOMA DE PUEBLA

SpanishEnglish

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School of chemical sciencesNATIONAL CHAMBER OF THE PHARMACEUTICAL INDUSTRYNATIONAL CHAMBER OF THE TRANSFORMATION INDUSTRY ASOCIACIÓN MEXICANA DE LABORATORIOS FARMACEUTICOS, BCNAC Academy System of Medicine of MEXICO, to. C.Assoc. Mexican pharmaceutical ATION, to. C.ASOCIACIÓN MEXICANA DE FARMACOVIGI LANCIA, to. C.National School of chemical FA RMACEUTICOS MEXICO biologists, to. C.PROD Pharmaceutical chemical UCTION, to. C.ASSOCIATION ALE, I.A.P.Mexican Association of professional Them in health regulation, to. C.NATIONAL ASSOCIATION OF MANUFACTURERS OF MEDICATIONS BCRED LATINOAMERICANA DE PHARMACOVIGILANCE AND NATIONAL B.C.MEXICAN ASSOCIATION OF INDUSTRIES OF PHARMACEUTICAL, BC RESEARCH.

INDEX

0. Introduction1. objective2. application3. references normative4. terms and Definiciones5. symbols and abbreviated terms6. members of pharmacovigilance in Mexico7. actions of the members of pharmacovigilance in Mexico8. methodology for Apharmacovigilance activities9. correspondswith international standards ncia10. bibliography11. Observance of the standard12. the conformity assessment13. force0. introductionThe therapeutic of a drug or vaccine use is based on criteria of efficiency, quality and safety, considered from the perspective

of the benefit/risk ratio. In general, drugs and vaccines are safe when their risks are considered acceptable in relation to theprophylactic benefit and therapeutic to contribute, i.e., when the pattern of adverse reactions is tolerable.

La pharmacovigilance is considered as one of the activities of public health, dedicated to the detection, identification,quantification, evaluation and prevention of possible risks arising from the use of drugs and vaccines in humans. Therefore is ashared responsibility activity among all the agents related to the drugs and vaccines: national system of health, professional health,institutions or establishments carrying out research into beings human, the registration holders or their legal representatives,distributors and marketers of the drugs, including vaccines, which are used in the treatment of human beings.

Based on the foregoing, the pharmacovigilance requires the collaboration of countries members of the international program ofmonitoring of medicines, of which Mexico is a member; and ende depends on the commitment and responsibility of all and each ofthe health professionals, the which obviously results in benefits for humanity.

1 objectiveThis standard establishes guidelines for the installation and operation of pharmacovigilance in the country.2. field of applicationThis standard is mandatory enforcement in the national territory for dependencies and entities of the Federal public

administration and local, as well as for the individuals or corporations of the social and private sectors, which are part of thenational health system, the health professionals institutions or establishments where is carried out research for health, as well asfor holders of the health records or their legal representatives, distributors and marketers of drugs and vaccines.

3. references regulationsFor the correct application of this standard, is should consult the following official rules Mexicanas or which replace them:3.1 Norma Oficial Mexicana NOM-004-SSA3-2012, clinical record.3.2 Standard Oficial Mexicana NOM-012-SSA3-2012, laying down criteria for the implementation of human health research

projects.3.3 Norma Oficial Mexicana NOM-017-SSA2-2012, for epidemiological surveillance. 3.4 Norma Oficial Mexicana NOM-036-SSA2-2012, Prevención and disease control. Application of vaccines, toxoids,

faboterapicos (Sera), and immunoglobulins in humans.3.5 Norma Oficial Mexicana NOM-059-SSA1-2015, Buenas drug manufacturing practices.3.6 Official Mexican standard NOM-072-SSA1-2012, labelling of medicines and remedies herbalists.3.7 Norma Oficial Mexicana NOM-073-SSA1-2015, Estabilidad of drugs and medicines, as well as herbal remedies.3.8 Standard officer Mexicana NOM-177-SSA1-2013, which set the tests and procedures for show that a drug is

interchangeable. Requirements to the third authorized must be secured the tests of interchangeability. Requirements to carry outthe studies of biocomparabilidad. Requirements to the third authorized, research centers or institutions must hold Hospitallerscarrying out tests of biocomparabilidad.

3.9 Norma Oficial Mexicana NOM-249-SSA1-2010, Mezclas sterile: nutritional and medicinal, and facilities for their preparation.3.10 Standard Oficial Mexicana NOM-257-SSA1-2014, in terms of biotechnological medicines.4 terms and definitionsFor purposes of this standard, it refers to:4.1 A drug abuse: the excessive use either persistent or sporadic intentionally of a medication, other than those authorized

information to prescribe conditions which can be accompanied by harmful physical effects or psicologicos.4.2 Audit: the process systematic, independent and documented to obtain evidence and evaluate them objectively in order to

determine the level which met the criteria set out in the this order, as well as hereellas arranged in paragraph 3. Referencesregulations, of this rule.

4.3 balance risk/benefit: to the result of the evaluation of the positive therapeutic effects of the drug or vaccine in relation torisks.

4.4 quality of information: to the completeness and integrity of the data contained in the notification.4.5 State Center of pharmacovigilance (CEFV): instance designated by the Ministry of health State and of the city of Mexico

to participate in the implementation of the activities of pharmacovigilance, in attachment to this standard and with the applicablerules, in coordination with the National Center of pharmacovigilance.

4.6 institutional Center of pharmacovigilance (CIFV): to the Pharmacovigilance unit of one institution of the national healthsystem which participates in the execution of the activities of pharmacovigilance.

4.7 Center institutional Coordinator of pharmacovigilance (CICFV): Instance responsible for coordinating to various unitsof pharmacovigilance an institution.

4.8 National Centre for pharmacovigilance (CNFV): to the area of the Commission's evidence and handling of Risks,attached to the Federal Commission for protection against health risks, which is responsible for according to the applicablelegislation, to issue policies and guidelines for the operation of the pharmacovigilance in the national territory.

4.9 Case closed: to the status in which according to standard operation procedures of the pharmacovigilance unit isconsidered the full case or follow-up attempts have been defined in such procedures, or when the informant refuses to providemore information.

4.10 new molecules (CMN) Committee: to the subsidiary body for consultation and opinion prior to requests records of drugsand other health supplies that are filed with the Secretary of health and which may contain a new molecule in terms of theregulation of inputs for health and rules applicable in the matter.

4.11 Advisory Committee: to the advisory body of consultation, which aims at the analysis and assessment of risks with theuse of drugs and vaccines.

4.12 confidential information: that should be rated exceptionally reserved of temporarily for reasons of public interest andnational security, or as confidential, in accordance with the provisions relating to transparency, access to information and personalinformation.

4.13 Distinctive name: name that as a trademark gives the lab or manufacturer to their proprietary medicinal products in orderto distinguish it from other similar, prior approval of the health authority and registration with the competent authorities.

4.14 generic name or generic name: the name of the drug or vaccine, given to through a preset, method that identifies thedrug or substance active, recognized internationally and accepted by the health authority.

4.15 amendment: any changes to a document that is part of the project or Protocol of research, derivative of variations to themethodological structure, replacement of the principal investigator or to the identification of risks in the subjects of research.Susceptible of amendment documents are: project or Protocol, manual, informed consent of the investigator, documents for thepatient, measuring scales and schedules.

4.16 medication error: any event preventable that may cause harm to the patient or lead to improper medicines and vaccines,when they are under the control of professionals of health or patient or consumer. These incidents may be linked with theprofessional practice, products, procedures or systems, including failures in the prescription, communication, labelling, packaging,name (distinctive or generic), preparation, dispensing, distribution, administration, education, monitoring, and use.

4.17 trial: to any research that takes place in humans and has as order to discover or verify the clinical, pharmacologicaleffects and/or other pharmacodynamic effects of a investigational product and/or identify any adverse reactions and/or study theabsorption, distribution, metabolism and excretion in order to evaluate the efficacy and safety of a medicinal product in research.For the purposes of this standard, are divided into two types: a) intervention studies (also known as clinical trials) and b) studies ofnon-intervention (observational). Includes the studies phase I, II, III and IV, referred to in article 66 of the regulation of the GeneralLaw of health in the field of research to health.

4.18 completed clinical study: is the clinical trial which has already ended and which counted with the final report.4.19 Study of pharmacovigilance (whose objective is security): to any clinical study related to a drug or approved vaccine

that seeks to identify, characterize or quantify a security risk, which makes it possible to confirm the safety profile of the drug orvaccine, propose effective measures and measure its effectiveness for the minimization of risks. These studies may have a studyof Interventional type or non-Interventional design.

4.20 Label: label, label, brand, or graphic image that has been written, printed, stencil, Dial, marked in relief or hollow,engraved, acceded or sealed in any susceptible material of contain the drug including the same container. As defined in article 2,fraction VIII of the regulation of inputs to health.

4.21 (EA) adverse event: to any undesirable medical event that can occur in a subject of Research during the stage of clinicalresearch of a drug or vaccine but not necessarily have a causal relationship with the.

4.22 event or medically important reaction : The clinical manifestation or event adverse that in the opinion of the physicianmay not be immediately life-threatening, result in the death or cause hospitalization, but may jeopardize the patient or requiremedical intervention to prevent the occurrence of any of the criteria listed in the definition of serious adverse reaction.

4.23 supposedly attributable to vaccination or immunization (AEFI) event: (s) manifestation (s) clinic (s) or medical eventthat occur after vaccination and are supposedly attributed to vaccination or immunization. Temporality depends on each one of thevaccines.

4.24 occupational exposure: exposure to a drug or vaccine as a result of a professional occupation or non-professional (forpurposes of notification of suspected adverse reactions).

4.25 lack of efficacy (therapeutic failure, therapeutic ineffectiveness): absence, decrease or changes in the therapeuticeffect that appear unexpectedly with application for the authorized indication drugs and vaccines.

4.26 pharmacovigilance: to activities relating to the detection, assessment, understanding and prevention of adverse events,suspected adverse reactions, adverse reactions, the events allegedly attributable to vaccination or immunization, or any othersecurity problem related to the use of medicines and vaccines.

4.27 format of notice of adverse events, suspicions of adverse reactions and reactions adverse drug: instrument issuedand administered exclusively by the CNFV used to make notification to the CNFV.

4.28 documentary source: to all document related to a notification, including, but not be limited to:4.28.1 A report of the telephone conversation or the initial of the notifier or responsible for mailing pharmacovigilance.

4.28.2 Format of notice of adverse events suspect adverse reactions and adverse reactions of drugs supplemented by thenotifier or person responsible for pharmacovigilance.

4.28.3 Results of additional tests or summaries of clinical histories.4.29 informant: a person who provides information about the Suspected adverse reaction to Drug, Adverse reaction to a

medication, EA, AEFI or any problem of security related to the use of medicines and vaccines. Occasionally the informant can alsobe the notifier.

4.30 review of pharmacovigilance: to the document issued by the CNFV based on the analysis of all the informationcontained in the newspaper reports of safety, risk management Plan, notification of suspected adverse reaction to drug Adversereaction to a drug, , EA, AEFI or anysecurity issue related to the use of medicines and vaccines, reports of safety of clinical studies and relevant national andinternational information.

4.31 missing information: to the absence of the knowledge about a drug or vaccine, related to security or the use in particularof patient populations that may be clinically significant. Some examples of missing information include populations not studied(example: women pregnant women or patients with severe renal failure), or use outside approved indications in the information forprescribing large.

4.32 reference safety information: to all contained relevant Security information at the authoritative information of the product(e.g. information to prescribe broad) prepared by the health registration holder or his legal representative in Mexico.

4.33 immunity: the biological state of the organism able to resist and defend themselves against the aggression of foreignagents; however, sometimes the body also acts against own substances.

4.34 Immunization: action of conferring immunity through the administration of antigens (active immunization) or through theadministration of antibodies (passive immunization).

4.35 insert (instructions or prospect): to information explaining in written or graphic form to the user utilization or any otherinformation of rational use of drug or vaccine, except advertising.

4.36 misuse of a drug or vaccine: to those situations in which way intentional e improper medication or vaccine is not used inaccordance with the authorized information.

4.37 medicine: to any substance or mixture of substances of natural or synthetic origin, having effect therapeutic, preventive orrehabilitating, which arises in pharmaceutical form and is identified as provided by their pharmacological activity, physical, chemicaland biological characteristics. When a product contains nutrients, will be considered as a medicinal product, provided that in thecase of a preparation containing of individually or associated: vitamins, minerals, electrolytes, amino acids or fatty acids, inconcentrations higher than the natural food and is also present in some form defined pharmaceutical and the indication of useinclude therapeutic, preventive effects or rehabilitatorios. As defined in article 221, section I of the General Health Act.

4.38 biotechnology drug: to any substance which has been produced by molecular biotechnology having effect therapeutic,preventive or rehabilitating, occurring in the form pharmaceutical, which is identified as such by their pharmacological activity andphysical chemical properties, and biological. Innovative biotechnological medications may be reference for drugs non-innovativebiotech, which identified as biocomparables. The form of identification of these products will be determined in the regulations. Asprovided for in article 222 Bis, of the General Law of health.

4.39 drug biotech biocomparable: the not innovative biotechnological medications that proves to be biocomparable in termsof safety, quality and efficacy to the biotechnology drug of reference through the evidence that establishes the General Health Act,the regulation of inputs to the health and other applicable provisions. As provided for in the article 2. , XIII Bis 1 fraction of theRegulation of inputs for health.

4.40 generic drug : to the proprietary medicinal product with the same drug or active substance and pharmaceutical form,concentration equal or power, which uses the same route of administration and required regulatory tests, has proven that theircompendial specifications, profiles of dissolution or its bioavailability or other parameters, as the case may be, are equivalent to theof the drug reference. As provided for in article 2. fraction XIV of regulation of inputs health.

4.41 drug or vaccine research: to the pharmaceutical form of a substance active or ((( placebo than: a) is being tested in aclinical trial, including products already having one marketing authorisation but used or assembled (formulated or packaged) are away different from the authorised form; b) it is used for an unauthorised indication and c) is used for more information about theauthorised form.

4.42 New molecule: the substance of natural or synthetic origin which is the active principle of a medication, not usedpreviously in the country, whose efficacy, safety and therapeutic purposes have not been completely documented in the scientificliterature. As provided for in article 2. , 15th fraction of the Regulation of inputs for health.

For the purposes of the Committee of new molecules, are to be classified as new molecules to those that are fall within thefollowing categories:

4.42.1 That drug or drug which does not have registry around the world and that will be registered in Mexico (new molecularentity).

4.42.2 That drug or medication that still exist in other countries, with limited clinical experience or controversial information, donot have registration in Mexico and intends to register in our country.

4.42.3 Medicine that intends to make a combination that does not exist in the national market of two or more drugs. 4.42.4 That drug or medication on the market purporting to be marketed with other therapeutic indication.4.43 notification: through action which is made of the knowledge to the CNFV one Suspicion of Adverse reaction to drug,

Adverse reaction to a medication, EA, AEFI in broadcast format for this purpose.4.44 spontaneous reporting/report: to any communication not requested by the holder of registration or his legal

representative in Mexico or agency regulatory or other body, in which the informant/notifier describes a single case report withsuspected adverse reaction to drug, Adverse reaction to a medication, EA, AEFI or any security issue related to the use ofmedicines and vaccines of a patient which was administered by one or more drugs/vaccines and that it does not arise from astudy.

4.45 stimulated notification/report: to those notifications from Suspected adverse reaction to Drug, Adverse reaction to amedication, AEFI or any related security issue with the use of medicines and vaccines generated from building with the aim ofincrease the spontaneous report.

4.46 Notifier: to the person who delivers the information relating to one suspected adverse reaction to drug, Adverse reactionto a medication, EA, AEFI or any security issue related to the use of medicines and vaccines to the CNFV.

4.47 Patient/consumer: the person who uses, receives or is given a medicine or vaccine, such as a patient or a healthy

person who consumes a drug or vaccine.4.48 safety profile of : to the result of the evaluation of the drug benefit/risk balance or vaccine, which is embodied in a

document.4.49 pharmacovigilance plan: to the document which described routine activities and some additional activities, according to

the specifications of safety of the drug or vaccine, designed to monitor, identify and characterize the risks of drugs or vaccines.East document is part of the risk management plan, then described routine activities and additional.

4.49.1 Additional activities: those that are considered necessary when the routine are not ((((( enough, andexample, but notlimited to manot limited to s, a) programs of pharmacovigilance, b) studies of c) stimulated reporting, pharmacovigilance, e) clinicalstudies, d) active surveillance.

4.49.2 Routine activities: to those applicable to all drugs and vaccines that are considered (((( necessary to identify, monitorand characterize the risks of medicines and vaccines, andsample, ma but not limitednot limited s, a) passive surveillance, b)spontaneous report c) series of cases, d) systematic methods for the evaluation of spontaneous reports.

4.50 (PMR) risk management plan: to the document that includes information about the profile of safety of medicines orvaccines and describes the measures taken to monitor, prevent and minimize the risks. Includes:

4.50.1 Safety of medication or vaccine;4.50.2 Pharmacovigilance plan, and4.50.3 Risk minimization plan.For the purposes of this standard, the risk management plans are classified into 3 categories depending on of the level of

complexity.4.51 Risk minimization plan: document that describes the activities and interventions that aim at preventing or reducing the

likelihood or severity of occurrence of adverse reaction to a drug associated with the use of the product. It is an integral part of riskmanagement Plan, and includes routine of minimization of risks and additional activities of minimization of risks.

4.52 concern of safety or security issue: important identified risk, risk significant potential or information missing from a drugor vaccine.

4.53 health professional: qualified, such as doctors, dentists, veterinarians, people biologists, bacteriologists nurses, socialworkers, chemical, psychologists, optometrists, engineers health, nutritionists, nutritionists, pathologists and all that professionalrelated to the chemical sciences -pharmaceutical and health sciences human, with certificates or professional titles ofspecialization which have been legally issued and registered by the educational authorities competent, in accordance with article79 of the General Health Act.

4.54 cut point of information (PCI): to the date on which the periodic reporting period ends safety, from which you mustcollect information for the delivery of the following periodic report of Security and that determines the maximum delivery time.

4.55 adverse reaction to a drug (RAM): to the unwanted response to a drug, in the which the causal relationship with this is,at least, reasonably attributable.

4.56 unexpected adverse reaction: to an adverse reaction, the nature or severity is not described information for prescribingthe product, nor in the documentation submitted for your health records.

4.57 report of exposure to drug or vaccine during pregnancy: any notification, where the Zygote, embryo, or fetus could

have been exposed to one or more drugs or your metabolitos or vaccines, during thehalf-life of elimination of the same period.4.58 a single case report: to the equivalent of a notification, containing the report of one or several suspected adverse

reaction to medication, RAM, EA, AEFI or any problem of security related to the use of drugs and vaccines that occurred with amedicine or vaccine, presenting a patient at a specific point in time.

4.59 safety of a clinical study report: to the detailed document that outlines the frequency and incidence of adverse eventspresented during the development of the clinical study. It may be of track (all changes made during the execution of the study) orend (the one done by the end of the study).

4.60 newspaper report of security (RPS): the document that provides an assessment of the balance a drug/vaccinerisk/benefit and that is submitted by the holder of the registration or his representative legal in Mexico to the CNFV in periodosdefined subsequent to the authorization of the registration or marketing of the product.

4.61 head of pharmacovigilance: a health professional trained in pharmacovigilance, responsible for coordinating andimplementing activities in pharmacovigilance, who will be the only valid interlocutor in this matter before the CNFV, in accordancewith applicable law.

4.62 identified risk: the medical event unwanted, for which there are sufficient evidence of a association with the drug orvaccine of interest.

4.63 important risk: identified or potential risk that can have a negative impact on the balance benefit/risk of product or whichhave implications for public health. What constitutes a significant risk will depend on several factors including the impact on theindividual, the seriousness of the risk and the impact on public health.

4.64 potential risk: the medical event, unwanted, for which there are bases that suggest a partnership with the drug or vaccineof interest, but this Association has not been confirmed.

4.65 signal: to information arising from one or more documentary sources, including observations and experiments, whichsuggests a potentially new causal Association or a new aspect of a Association previously known between an intervention and anevent or set of events, already , whether adverse or beneficial and which is considered sufficient to justify an action of verificationof the information.

4.66 new signal: to signal that has been identified during the evaluation of the benefit/risk of the report newspaper of security.Also, is considered as a new landmark when clinical information of a previously closed signal is available during the evaluation ofthe periodic report interval of safety.

4.67 Signal in the process: which remains under evaluation in the cutoff point of information during the assessment of thebenefit/risk of periodic safety report.

4.68 closed signal: those whose valuation has been completed during the evaluation of the benefit/risk periodic safety report.4.69 applicant for registration: to the person or entity that is in the process of obtaining of a health registry. For the purposes

of this standard apply you the obligations of the holder of the registration or your legal representative in Mexico.4.70 pharmacovigilance quality assurance system: the organizational structure that integrates: responsibilities, procedures,

processes and resources of the pharmacovigilance system; as well as the appropriate resources, compliance and recordsmanagement. The quality assurance system is used in the units of pharmacovigilance, the institutional centres, the State centres,centres institutional coordinators, among others.

4.71 Overdose: to the use of a drug or vaccine to a dose higher than stipulated in their information for prescribing authorizedfor an indication or particular population.

4.72 Adverse reaction suspected medicine (SRAM): to any clinical manifestation or unwanted laboratory occurring afteradministration of one or more medications.

4.73 authorized third party: the person authorized by the Ministry of health to issue opinions regarding the fulfilment ofrequirements established by the Ministry or in the rules corresponding or to study, for the purpose of proceedings or sanitaryauthorizations, according to the in article 2. , fraction XVIII, of the regulation of inputs for health.

4.74 holder registration or his legal representative in Mexico: to the natural person or morals to holds the registrationgranted by the Federal Commission for protection against health risks for a drug/vaccine, which complies with article 168 ofregulation of inputs for health and other applicable regulations.

4.75 pharmacovigilance unit (UFV): the entity dedicated to the implementation and development of pharmacovigilanceactivities.

4.76 out of authorized indication: to those situations in which the drug/vaccine is used intentionally for a medical purpose ornot established in the information for prescribing indicationauthorized product.

4.77 vaccine: the biological preparation intended to produce immunity to a disease by antibody production, to eliminate,prevent or control disease States.

4.78 vaccination: the application of a product of immunizing an organism in order to protect it against the risk of a particulardisease, this action does not necessarily produce immunization, already that the immune response varies from one individual toanother.

4.79 Rating of the causality: to the methodology used to estimate the probability of attributing to a drug or vaccine adversereaction observed. Located in the adverse reactions in categories probabilistic.

5. symbols and abbreviated termsThe meaning of the abbreviations used in this standard, is as follows:5.1 CAS = Committee on sanitary authorization.5.2 CIS = integrated services center.5.3 COFEPRIS = Federal Commission for protection against health risks.5.4 EMA = European Medicines Agency, for its acronym in English: European Medicines Agency5.5 ICH International Conference on harmonization, by its acronym in English, International Conference = on Harmonisation of

technical requirements for registration of pharmaceuticals for human use.5.6 IPPA = information for prescribing large.5.7 MedDRA = medical dictionary for regulatory activities (for its acronym in English: Medical Dictionary for Regulatory

Activities).5.8 Who = World Health Organization.5.9 PNO = standard operation procedure.6. members of pharmacovigilance in MexicoA solid structure that permits is required to carry out the pharmacovigilance in Mexico address the needs and demands of

public health. Pharmacovigilance is formed by the following members:6.1 CNFV.6.2 CEFV.6.3 CICFV.6.4 UFV.6.4.1 Health record owners or their legal representatives.6.4.2 CIFV.6.4.3 Of the national health system.6.4.3.1 Public.6.4.3.2 Social.6.4.3.3 Private.6.5 Institutions or establishments where health research is made.6.6 Distributors / marketers (points of sale).6.7 Health professionals.6.8 Patients consumers.7. actions of the members of pharmacovigilance in Mexico7.1 From COFEPRIS, through the CNFV:7.1.1 Establish and disseminate policies, guidelines, criteria, methodologies, programs, manuals, procedures, guides, as well

as requirements and formats in pharmacovigilance, which is broadcast on the website of the COFEPRIS(http://www.gob.mx/cofepris/documentos/guias-guidelines-and-requirements-of-pharmacovigilance? state = draft).

7.1.2 Coordinate and monitor pharmacovigilance activities carried out by the above-mentioned members in points 6.2 to 6.8 ofthis standard, in accordance with the applicable regulations.

7.1.3 Act as a centre of reference in the field of pharmacovigilance in the country.7.1.4 Manage the safety of medicines and vaccines information.7.1.5 Promote actions in the field of security, contributing to the well-being of patients and to use rational medicines and

vaccines, in accordance with the international program of monitoring of the drugs from the who.7.1.6 Verify the information on the safety profile of medicines and vaccines delivered by the holder or his legal representative in

Mexico and retroalimentarlo for the purpose of registration holders health take appropriate corrective and preventive actions.7.1.7 Set the pattern for encoding identification for notifications.7.1.8 Technical opinion to the administrative units of the COFEPRIS regarding safety of

drugs and vaccines.7.1.9 Issuing the report of pharmacovigilance for the extension of the registration.7.1.10 Carry out in collaboration and coordination with the relevant committees of the COFEPRIS the verification of

pharmacovigilance activities; either routine or targeted.

7.1.11 Evaluate and approve the protocols of pharmacovigilance studies.7.1.12 Ask for the opening of the code assignment of the subject affected by a serious EA during the conduct of clinical studies.7.1.13 Apply for early termination or suspension of a trial when it is identified that the risks outweigh the benefits of continuing

with the study.7.1.14 Carry out activities of risk communication in order to prevent and protect to the population.7.1.15 Meet the activities of pharmacovigilance in coordination with other international agencies regulatory and safety in

medicines and vaccines.7.1.16 Having an Advisory Committee, which will act as an advisory body of inquiry for the evaluation of specific cases in the

field of safety of medicines and vaccines as well as decision making.7.1.17 Determine or validate the causality, severity, severity and degree of information based on the data received in the

notifications.7.1.18 Feedback from the notifications actions.7.1.19 Evaluate and approve the PMR, RPS and reports of safety of clinical studies, according to the legislation.7.1.20 Evaluate and approve pharmacovigilance studies by researcher initiative, according to the legislation.7.1.21 In accordance with the General picture of archival classification and catalog of available Documentary of the Secretaryto

retain health information related to the activities of corresponding pharmacovigilance by a periminimum period of 6 years from itselaboration.

7.1.22 Perform according to this directive and the applicable provisions, internal audits. Be must document this process.7.2 Of the CEFV.7.2.1 Designate a State head of pharmacovigilance.7.2.2 Inform the CNFV any change in the State of pharmacovigilance and maintain responsible updated the directory of

pharmacovigilance from the units responsible for dependants.7.2.3 Maintain a system of quality assurance that will allow the fulfillment of the process of Pharmacovigilance, in State Center.7.2.4 Develop and keep updated a manual of the pharmacovigilance PNO certified by the CNFV.7.2.5 Foster and promote the quality of the notification with the professionals of the health and population in the federal entity

concerned.7.2.6 Participate in coordination with the CNFV in accordance with the provisions applicable.7.2.7 Promoting activities of training, dissemination and promotion of pharmacovigilance.7.2.8 Activities for the detection of duplication of cases received, according to the established pharmacovigilance Guide for the

development of the activities of the State centers of pharmacovigilance, which can be found athttp://www.gob.mx/cofepris/documentos/guias-guidelines-and-requirements-of-pharmacovigilance? state = draft.

7.2.9 Support and ask for the follow-up of the cases received.7.2.10 In accordance with the General picture of C lasificacion archival and tasting target logo alarm Documentary of the

Secretaryto retain health information related to the activities of corresponding pharmacovigilance by a periperiod of 6 years from itselaboration.

7.2.11 Safeguard the confidential information of the notifier and the patient, in accordance with the provisions relating totransparency, access to information and data protection personal.

7.2.12 Coordinate the activities of surveillance of the national health system units of its jurisdiction within its federal entity, inaccordance with the provisions applicable.

7.2.13 Inform the state epidemiologist the AEFI during vaccination program identified Universal and send copies to the CNFV.7.2.14 Analyze data from cases received in their State and ensuring the quality of notifications information.7.2.15 Carry out the screening of cases received from SRAM/AEFI based causality in the the CNFV criteria (the final evaluation

of the notifications you will be up to the CNFV).7.2.16 Notify the CNFV received from EA, RAM, SRAM, AEFI cases and any other problem of safety related to the use of

medicines and vaccines. 7.2.17 Carry out internal audits in accordance with this standard. This process should be documented.7.3 Of the CICFV, shall be liable for in accordance with the relevant provisions of:7.3.1 Designate a person responsible for pharmacovigilance.7.3.2 Report to the CNFV any change to the person responsible for pharmacovigilance and keep updated the Directory of

responsible for pharmacovigilance of the units in charge.7.3.3 Maintain a system of assurance of quality for the fulfillment of the process of Pharmacovigilance, in the CICFV.7.3.4 Develop and keep updated a manual of the pharmacovigilance PNO certified by the CNFV.7.3.5 Foster and promote the quality of notification with health professionals in the your competition institutions.7.3.6 Participate in coordination with the CNFV in accordance with the provisions applicable.7.3.7 Activities of training, dissemination and promotion of pharmacovigilance.7.3.8 Activities for the detection of duplication of cases received, according to the established pharmacovigilance Guide for the

development of the activities of the Centre institutional of pharmacovigilance and Center institutional Coordinator ofpharmacovigilance, same which can be consulted in http://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia? state = draft.

7.3.9 Support and ask for the follow-up of the cases received.7.3.10 In accordance with the General picture of C lasificacion archival and tasting target logo alarm Documentary of the

Secretaryto retain health information related to the activities of corresponding pharmacovigilance by a periperiod of 6 years from itselaboration.

7.3.11 Safeguard the confidential information of the notifier and the patient, in accordance with the provisions relating totransparency, access to information and data protection personal.

7.3.12 Coordinate the activities of pharmacovigilance units within your institution, according to provisions applicable.7.3.13 Inform the state epidemiologist the AEFI during vaccination program identified Universal and send copies to the CNFV,

in accordance with specified in the Manual of events Supposedly attributable to vaccination or immunization, published inhttp://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia.

7.3.14 Carry out the screening of causality of the cases received from SRAM (the final evaluation of the notifications will

correspond you to the CNFV).7.3.15 Notify the CNFV received all SRAM, EA, RAM, AEFI cases and any other problem of safety related to the use of

medicines and vaccines.7.3.16 Participate together with the CNFV and the registration holders or their representatives legal in pharmacovigilance

studies approved by the CNFV.7.3.17 Organize a hospital Committee of pharmacovigilance, which report regularly upon the results of pharmacovigilance.7.3.18 Perform in accordance with this standard, internal audits and allow the realization of monitoring by the Commission of

health operation from COFEPRIS. It should document said process.7.4 Of the UFV7.4.1 All the UFV shall be liable, in accordance with the relevant provisions of:7.4.1.1 Having a head of pharmacovigilance.7.4.1.2 Keep updated to the CEFV or CICFV to which unit belongs, with a copy to the CNFV, the identity of the person

responsible for pharmacovigilance. Units that do not belong to a CEFV or a CICFV, must maintain the identity of the personresponsible for pharmacovigilance directly to the CNFV. The responsible for pharmacovigilance shall be the only valid interlocutorin terms of pharmacovigilance.

7.4.1.3 Develop and comply with a manual containing the PNO which guarantee the performance of the actions described inthis standard, with attachment to pharmacovigilance guidelines according to each process and activity developed, published by theCNFV in http://www.gob.mx/cofepris/documentos/guias-guidelines-and-requirements-of-pharmacovigilance.

7.4.1.4 Carry out the reception and registration of cases of SRAM, RAM, AEFI reports EA that arise in your area to completethe notification of attachment as described in and in the point 8.1 of this standard.

7.4.1.5 Encourage notification of SRAM, RAM, AEFI, EA or any security problem related to the use of drugs and vaccines withemphasis on ensuring the quality of the required to notify information.

7.4.1.6 Safeguard the confidential information of the patients/informants and Notifiers, from accordance with the provisionsrelating to transparency, access to information and protection of personal data.

7.4.1.7 Develop and implement a program of training, dissemination and promotion of case reports of pharmacovigilance.7.4.1.8 Participate in coordination with the CNFV in accordance with the provisions applicable.7.4.1.9 In accordance with the General picture of C lasificacion archival and tasting target logo alarm Documentary of the

Secretaryto retain health information related to the activities of corresponding pharmacovigilance by a periminimum period of 6years from its elaboration.

7.4.1.10 Notify the CNFV of all SRAM, EA, RAM, AEFI and any other security problem related to the use of medicines andvaccines.

7.4.1.10.1 When they are temporarily or permanently the computing infrastructure for the the notification of electronics in E2Bformat, should be sent to the CICFV or corresponding CEFV, the case reports by way of communication with.

7.4.1.10.2 When they have the infrastructure of computation for the electronic notification of they must send to the CNFV,notifications by this medium in format E2B.

7.4.1.11 Participate together with the CNFV and the registration holders or their representatives legal in pharmacovigilancestudies approved by the CNFV.

7.4.1.12 Organize a hospital Committee of pharmacovigilance, which report periodically on the results of pharmacovigilance.7.4.1.13 Perform in accordance with this standard, internal audits and allow the realization of monitoring by the Commission of

health operation from COFEPRIS. It should document said process.7.4.2 Of the owners of the records health or their legal representatives in Mexico.In addition to being responsible for provisions of 7.4.1.1, 7.4.1.2, 7.4.1.3, 7.4.1.4 7.4.1.5, points 7.4.1.6, 7.4.1.7 7.4.1.8, 7.4.1.9,

7.4.1.10 and 7.4.1.13 of this standard, the holder of the registration or his legal representative in Mexico carry out the followingactions:

7.4.2.1 Draw up and send to the CNFV the RPS.7.4.2.2 Draw up and send to the CNFV for approval and allocation of the coding, the PMR.7.4.2.3 Prepare and send to the CNFV safety in clinical studies report.7.4.2.4 Perform the PMR.7.4.2.5 Respond to information requirements, drug safety and vaccines, from health authority.7.4.2.6 Update the IPPA whenever there are changes in the following sections: indication therapy, adverse reactions,

interactions, precautions and contraindications and any other section affecting the safety profile of medicines and vaccines, orthose required sections of the IPPA by the authority.

7.4.2.7 Keep posted to the CNFV with the latest authorized of the IPPA.7.4.2.8 Notice to any transfer of rights of registration CNFV.7.4.2.9 Notice to the CNFV of clinical trials authorized by CAS protocols.7.4.2.10 Notice to the CNFV of the cancellation, suspension, discontinuance or resumption (including the reasons thereof) of all

clinical studies sponsored by this and who have with at least one Centre for research in Mexico. The notice must be within amaximum of 15 working days starting from the cancellation, suspension, or discontinuance. If you resume a canceled, suspendedstudy and/or discontinued give notice within a maximum period of 15 business days after the resumption of.

7.4.2.11 Inform the CNFV on national or international product safety alerts marketed or in process of registration application.7.4.2.12 Draw up and send to the CNFV the safety profile of medicines and vaccines (when required) , for the verification of

this.7.4.3 The CIFV, shall be liable, in accordance with the relevant provisions of:The CIFV during the course of its construction ades practice clinic will take n place the actions established in section 7.4.1 of

this standard, and shall in addition:7.4.3.1 Organize a hospital Committee of pharmacovigilance, which report regularly upon the results of pharmacovigilance.7.4.3.2 Inform the epidemiologist of the corresponding unit identified AEFI during the Universal vaccination program.7.4.3.3 Comply with this standard point 7.5 if activities are carried out in clinical research in your institution.7.4.3.4 Will carry out the screening of causation of SRAM/AEFI notifications based to the stipulated by the CNFV (the final

evaluation of the notifications you will be up to the CNFV).

7.4.4 Other members of the national health systemIn addition to the actions set out in section 7.4.1 of this standard, the UFV should be: 7.4.4.1 Comply with the point 7.4.1.12 of this standard, when you apply.7.4.4.2 Comply with section 7.5 of this standard when they carry out activities in clinical research in your institution.7.5 Of institutions or establishments where health research is carried out.In addition to the actions set out in section 7.4.1 of the present standard, anyone carry out clinical research should be:7.5.1 Ask the CNFV approval and allocation of individual notification coding pattern for all protocols of pharmacovigilance

studies and studies on the initiative of the researcher, according to the applicable regulations.7.5.2 Notice to the CNFV of the cancellation, suspension, discontinuance or resumption (including the reasons thereof) of all

clinical studies sponsored by this and who have with at least one Centre for research in Mexico. The notice must be within amaximum of 15 working days starting from the cancellation, suspension, or discontinuance. If you resume a canceled, suspendedstudy and/or discontinued must give notice within a maximum period of 15 working days of resumption.

7.5.3 Draw up and send to the CNFV reports of safety studies of pharmacovigilance that are studies on the initiative of theinvestigator.

7.5.4 When the clinical trial is carried out in collaboration with any other Member of the Pharmacovigilance in Mexico, theactivities described above, must be carried out by means of mutual agreement.

7.6 Of the distributors/marketersRetailers and marketers must:7.6.1 Designate a person responsible for the notification of SRAM, AEFI and any other problem of safety related to the use of

medicines and vaccines, trained in activities of pharmacovigilance.7.6.2 Count with PNO in the field of pharmacovigilance for the SRAM, AEFI reporting and any other security problem related to

the use of medicines and vaccines.7.6.3 Carry out the receipt, recording and notification of cases of SRAM, AEFI reports and any other security problem related to

the use of medicines and vaccines, which are present in his universe of work to complete its notification with attachment asdescribed in 8.1 of this standard.

7.6.4 Participate in coordination with the CNFV in accordance with the provisions applicable.7.6.5 Having the PNO for continuous training to staff on pharmacovigilance.7.7 Professionals of the healthThe P health professionals will take n out:7.7.1 Reception, registration and notification in case of RAM, SRAM, EA, AEFI reports and any another security issue related

to the use of medicines and vaccines, UFV, or the CNFV, as well as the errors of medication, exposure to drugs or vaccines duringpregnancy and lactation of that are aware to complete its notification with attachment in point 8.1 of the this standard.

7.7.2 Cooperation with the CNFV and the corresponding UFV, in order to expand, complete or collect more information relatedto notification.

7.7.3 Keep informed and updated about the safety data concerning vaccines and the medications that prescribe, dispense oradminister.

7.7.4 Feedback to their patients with information about the safety of medicines and vaccines to use. In addition to tell them theconduct to be followed in case of any EA, SRAM, AEFI and any other security problem related to the use of medicines andvaccines.

7.7.5 Participate together with the CNFV in accordance with the provisions and activities that set, including in theimplementation of risk management plans.

7.7.6 Continuously participate in the dissemination and promotion of pharmacovigilance activities.7.8 Of patients or consumers7.8.1 Inform / notify the CNFV or any other Member of the pharmacovigilance referred to the points 6.1 to 6.8 of this standard

of any SRAM or AEFI that may arise during and after Administration of medicines and vaccines, including those related to misuse,abuse, overdose, lack of effectiveness or medication errors, which arise during and after the Administration of medication(prescribed or not by a doctor) and vaccines.

8. methodology for Apharmacovigilance activities8.1 Notification. Criteria and requirements for the notification/reports:8.1.1 Types of notices/reports:8.1.1.1 Spontaneous.8.1.1.2 Spurred. 8.1.1.3 Clinical study phases I, II, III and IV.8.1.1.4 Pharmacovigilance studies.8.1.1.5 Case of scientific literature.8.1.2 Criteria to notify the CNFV:8.1.2.1 All the SRAM, EA, RAM, AEFI and other security problems related to the use of drugs and vaccines, both expected and

unexpected, submitted by:8.1.2.1.1 Use to dose or therapeutic indications according to the IPPA or label of the drug or vaccine.8.1.2.1.2 Overdose and abuse.8.1.2.1.3 Use outside authorized according to the IPPA of medication or vaccine.8.1.2.1.4 Occupational exposure.8.1.2.1.5 Self-medication.8.1.2.1.6 The development of clinical trials phases I, II, III and IV.8.1.2.1.7 Result of the review of scientific literature.8.1.2.1.8 Lack of efficacy (therapeutic failure or therapeutic ineffectiveness), with the largest amount of data possible clinical.8.1.2.1.9 Exposure to drugs and vaccines during pregnancy and lactation.8.1.2.1.10 Suspicion of forgery.8.1.2.1.11 Medication errors.

8.1.3 The minimum quality of the information in the notification will be 0 degree and it should be mandatory follow-up to suchnotification until the subsequent degrees of quality of information set out in item 8.1.4 of this standard or until the close of the case.In the case biological/biotechnological medicines and vaccines, you must also include name and lot number laboratorymanufacturer.

8.1.4 Criteria for determining the degree of information:8.1.4.1 0 degree. Include: a) an identifiable patient/consumer; b) at least one SRAM, RAM, EA, AEFI or any other security

problem related to the use of drugs and vaccines; (( c) drug or vaccine suspect) and (d) the notifier data.8.1.4.2 Grade 1. When in addition to the 0 degree data, include: a) dates of onset of the SRAM, EA, RAM or AEFI; b) date of

commencement of treatment and c) date of the end of the treatment (day, month and year).8.1.4.3 Grade 2. When in addition to the grade 1 data, is incluyen: to) generic name; (( b) distinctive designation; c) dosage; (d)

route of administration; (e) prescribing motive; ((f) consequence of the event ; g) important data of the clinical history for the case;((h) number of the lot and i) name of laboratory manufacturer.

8.1.4.4 Grade 3. When in addition to the grade 2 data, is the result of re-administration of the medication or vaccine.8.1.5 Criteria for determining the seriousness of a case:8.1.5.1 Graves (serious). All clinical manifestation that occurs with the administration of any dose of a medication including

vaccines, and that:8.1.5.1.1 Cause the death of the patient.8.1.5.1.2 Endanger the patient's life at the same time presented.8.1.5.1.3 Make it necessary to hospitalize or prolonged hospital stay.8.1.5.1.4 Are cause of invalidity or permanent or significant disability.8.1.5.1.5 Are cause of alterations or malformations in the newborn.8.1.5.1.6 Are considered medically important.8.1.5.2 Non-serious. The SRAM, RAM, EA or AEFI or any other security problem related with the use of medicines and

vaccines that do not meet severity criteria specified in paragraph 8.1.5.1, of this standard.8.1.6 Criteria for determining the severity of the case: SRAM, RAM, EA or any other security problem related to the use of

medicines and vaccines, are classified according to the intensity of the clinical manifestation in:8.1.6.1 Lèves. They present with signs and symptoms easily tolerated, don't need treatment, not require or prolong

hospitalization and not requires stopping the causative drug.8.1.6.2 Moderate. Interfere with usual activities (can cause low work or school), without directly threatening the patient's life.

Requires drug treatment and can or not require stopping the causative drug.8.1.6.3 Hefty. Interfere with usual activities (can cause low work or school). Requires drug treatment and stopping the causative

drug. 8.1.7. adverse reactions are classified:8.1.7.1 In accordance to the one provided by the World Health Organization causality estimation and the center of monitoring

the Uppsala specified in paragraph 10.21 of this standard, the categories probabilistic are as follows:8.1.7.1.1 Certain. A clinical event, including alterations in the lab tests, which is manifests with a plausible temporal sequence

in relation to the administration of the medication, and not can be explained by concurrent disease, or for other drugs orsubstances. The response to the removal of the drug (withdrawal) must be clinically plausible. The event must be definitive from adrug or perspective phenomenological, using, if necessary, a procedure of re -conclusive exhibition.

8.1.7.1.2 Probable. A clinical event, including alterations in the lab tests, which manifests itself with a temporal sequence that isreasonable in relation to the administration of the medication, that is unlikely that it attributed to the disease concurrent, or to otherdrugs or substances, and that by removing the drug presents a clinically reasonable response. Is not required to have informationabout re -exposure to assign this definition.

8.1.7.1.3 . Possible a clinical event, including alterations in the lab tests, which is manifests with a reasonable time sequence inrelation to the administration of the medication, but that can be explained also by concurrent disease or other drugs or substances.The information regarding the withdrawal of the drug can fail or be not clear.

8.1.7.1.4 Improbable. A clinical event, including alterations in laboratory tests, that manifests itself with a temporal sequenceunlikely in relation to the administration of the medication, and that can be explained in a way most plausible, concurrent diseaseor other drugs or substances.

8.1.7.1.5 Conditional/not rated: a clinical event, including alterations in the tests of laboratory, reported as an adverse event,which is essential to get more data for power make a proper assessment or the additional data are under examination.

8.1.7.1.6 Not evaluable/Inclasificable: a notice suggesting an adverse reaction, but not can be judged since the information isinsufficient or contradictory, and which can not be verified or completed its data in.

8.1.7.2 For the assessment of causality, the CNFV may also use other methodologies of evaluation of causality which havebeen endorsed and published by the who-UMC, applied by some regulatory authority and adapted by the CNFV.

8.1.8 Criteria for determining the need for follow-up. He is tracking when you add new medical or administrative information thatmay impact the assessment, management or criterion of a notification severity. Monitoring is required in the followingcircumstances:

8.1.8.1 Notification with a degree of 0.8.1.8.2 Notice of exposure to drugs and vaccines during pregnancy or breast-feeding:8.1.8.2.1 In the event of exposure during pregnancy, the necessary follow-ups will be throughout the pregnancy and at least

during the first six months of life of the newborn.8.1.8.2.2 During lactation necessary follow-ups will be all breastfeeding and at least during the three months after having

completed, time tracking will be higher for the drugs with more than three months average life times.8.1.8.3 Notification of SRAM, RAM, EA and AEFI or any related security problems with the use of medicines and vaccines that

have not completed.8.1.9 Must be carried out in the case of the EA, SRAM and AEFI of drugs and vaccines, the pre -assessment or evaluation of

causality in accordance with guidelines of pharmacovigilance for the development of the activities of the institutional centre ofpharmacovigilance and institutional coordinating Center of pharmacovigilance, pharmacovigilance Guide for the development ofthe activities of the centres State of pharmacovigilance or Manual events allegedly attributable to vaccination or immunization(AEFI), as appropriate that they can be consulted at http://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-

de-farmacovigilancia?state=draft.8.1.10 Terminology for classifying clinical manifestations, laboratory and/or cabinet:8.1.10.1 From notifications of health professionals, holders of registration or their legal representatives, institutions or

establishments which intend to or carried out research into beings human and distributors / retailers, should be the codification ofthe clinical manifestation reported in the notification, using the existing MedDRA terminology.

8.1.10.2 From notifications of patients/consumers will not require the use of the MedDRA terminology; it is desirable to have asmuch as possible information about the reaction notified.

8.1.11 Shipping times of notifications on national territory to the CNFV, are set in thetable below:

Table 1. Notification of the EA, SRAM and RAM times.

Criterion Spontaneous reporting /stimulated

Notification of I clinical trials,II, III, IV which are not of

Pharmacovigilance (includesBioequivalence andbiocomparabilidad)

Notification of study orProgram of

Pharmacovigilance

SRAM or serious EA 7 calendar days maximum 7 calendar days maximum * 7 calendar days maximum

SRAM or non-severe EA 90 calendar days maximum Notice at the end of the study 90 calendar days maximum

Two serious cases ormore, like in the sameplace, with the samemedication and of thesame batch.

Immediately, without exceeding 48hours

Immediately, without exceeding 48hours

Immediately, without exceeding48 hours

Lack of efficacy 15 calendar days maximum

Notification of Scientificliterature

30 calendar days maximum

* The zero-day is the day that responsible for notify has knowledge of the case.* Severe cases happen only abroad must be given in the final safety report study (only in case that the study has a research

center in Mexico).8.1.11.1 The time of sending the information in country to the CNFV of the AEFI are established in the following table:

Table 2. Notification of the AEFI times.

Criterion

NotificationSpontaneous

(National systemHealth)

Notificationspontaneous (CEFV,

CIFV, CIC, UFV)

Holders ofHealth registration

or theirrepresentatives

legal

Notification ofclinical studies I, II,

III and IV that are not ofPharmacovigilance

Notification ofStudy or program

pharmacovigilance

Serious AEFIImmediately,

not exceeding 48hours

7 working daysmaximum

Immediately, withoutexceed 48 hours *

maximum 7 business days * Immediately, withoutexceed 48 hours

No serious AEFI7 working days

maximum15 business days

maximum15 business days

maximumNotice at end of the

I am a student 7 working days maximum

Two serious casesor more, like in thesame place, with thesame vaccine andfrom the same batch.

Immediately,not exceeding 48

hours

Immediately, withoutexceed 48 hours

Immediately, withoutexceed 48 hours

Immediately, withoutexceed 48 hours

Immediately, withoutexceed 48 hours

Lack of efficacy 15 calendar days maximum

Notification ofLiterature scientific 30 calendar days maximum

* The zero-day is the day that responsible for notify has knowledge of the case.* Time to deliver information available. They have a period within 15 calendar days to deliver the full report from day zero.

Severe cases happen abroad sorit be included in the report of final safety study (only when the study has a Center research inMexico).

8.1.12 Receiving channels and formats for notifications to the CNFV:8.1.12.1 Notifiers should use exclusively means establishing the CNFV, except patients or consumers who may notify as

provided in sections 7.8.1 and 8.1.12.3, of the this standard.8.1.12.2 Holders of registration or its officers, professional of the health (public and private) , institutions or establishments that

carry out health research, distributors / marketers, must submit to the CNFV notifications using systems that adhere to standardsinternational regulations for pharmacovigilance (ICH-E2B) and the applicable provisions of transparency, access to information andprotection of personal data, and the format of the CNFV. Said format will be managed exclusively by the CNFV.

8.1.12.3 The notification/reports from patients or consumers may be made directly to the CNFV (electronically, through thecomprehensive centers of services established in the territory national or by any other means that the CNFV population).

8.1.13 Requirements for the reception of notifications in the CNFV: 8.1.13.1 Encoding.8.1.13.1.1 All the notifications received must be attached to the coding patterns established by the CNFV and in accordance

with the provisions in the "pharmacovigilance Guide for the EA, SRAM, RAM and AEFI notification or any security issue related tothe use of drugs and vaccines, published by the CNFV in http://www.gob.mx/cofepris/documentos/guias-guidelines-and-requirements-of-pharmacovigilance? state = draft. "

8.1.13.1.2 The encoding must be unique for each notification in order to allow the traceability between initial notifications andfollow-up.

8.1.13.1.3 Only codes for degree of equal information notifications should be generated or greater than 0.8.1.13.2 Duplicity.8.1.13.2.1 Each holder of registration or its legal representative, the CEFV, the CICFV, UFV, or the CIFV must make a

detection of duplicity in his universe of previous work data to the sending notification to CNFV.8.1.13.2.2 Before any suspicion of duplicity it should investigate all cases involved; if necessary will be requested the

participation of the initial notifier to provide further information.

8.1.13.3 Specifications for the transmission of notifications.8.1.13.3.1 To perform an adequate analysis of causation, it is necessary that the information of each case reported to be

submitted in a complete and structured, contemplating the elements required by the ICH-E2B existing. This means that theinformation can be repeated in the narrative section. In addition, the information from the clinical manifestations must be attachedto the existing MedDRA terminology.

8.1.13.3.2 When the notifier has not transmitted the information complete case, the CNFV or the CEFV may request you tosend the case with the full information in accordance with the established in the "pharmacovigilance Guide for EA, SRAM, RAMand AEFI reporting or any security issue related to the use of medicines and vaccines, published by the CNFV athttp://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia?state=draft. "

8.1.13.3.3 To ensure the proper transmission of notifications, each Member should implement and maintain procedures andsecurity measures in order to protect confidential information contained in the notifications.

8.1.13.3.4 You must have measures that prevent against unauthorized access disclosure, alteration, delay, destruction or lossof information, ensuring the integrity check, the confidential information and the availability of the information in the notifications forthe CNFV.

8.2 RPS8.2.1 Authorized RPS for all drugs and vaccines will be developed.8.2.2 Will be an RPS for each health record in the format provided by the CNFV in the "Guide pharmacovigilance for the

elaboration of the RPS", published by the CNFV in http://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia?state=draft.

8.2.3 The RPS must contain at least the following points:8.2.3.1 Front page.8.2.3.2 Executive summary.8.2.3.3 Table of contents.8.2.3.3.1 Introduction.8.2.3.3.2 State of authorisation in the national and international market.8.2.3.3.3 Update of the actions taken by regulators for reasons of safety.8.2.3.3.4 Changes to the reference of the product safety information.8.2.3.3.5 Estimation of exposed patients.8.2.3.3.6 Summary table of individual cases of RAM, SRAM, AEFI, EA or any other problem of safety relating to the use of

medicines and vaccines, accumulated.8.2.3.3.7 Summary of facts presented during clinical studies within the reporting period.8.2.3.3.8 Findings in studies whose principal objective is safety.8.2.3.3.9 Information from other clinical trials.8.2.3.3.10 Pre-clinical/non-clinical information.8.2.3.3.11 Scientific literature.8.2.3.3.12 Other periodical reports.8.2.3.3.13 Lack of efficacy in clinical studies.8.2.3.3.14 Updated information.8.2.3.3.15 Generation of signals: new, ongoing and closed.8.2.3.3.16 Signals and risk evaluation. 8.2.3.3.17 Overview about security problems in Mexico.8.2.3.3.18 Evaluation of the benefit.8.2.3.3.19 Analysis of the benefit-risk balance.8.2.3.3.20 Conclusions and actions.8.2.3.3.21 Annexes. You must include a copy of the registration and the authorized IPPA.8.2.4 Information of the RPS in accordance with the provisions applicable, must comply with the following periods once started

marketing in Mexico:8.2.4.1 Every 6 months during the first 2 years.8.2.4.2 Annual during the following 3 years.8.2.4.3 Then every 3 years.8.2.4.4 Once started marketing in Mexico surrendered 4 semester during the 2 RPS early years of marketing, and then

delivered an annual RPS for each of the next 3 years.From this last RPS registration holder delivered at three-year intervals subsequent RPS.8.2.5 For those products that have an international calendar, registration holders be submitted within a maximum period of 3

years a first report whose cut-off point is coincident with the international calendar and will continue with the corresponding triennialRPS.

8.2.6 The RPS must be sent to the CNFV, post-PCI, in a maximum time of:8.2.6.1 Semi-annual: 70 calendar days.8.2.6.2 Annual: 90 calendar days.8.2.6.3 Trianuales: 90 calendar days.8.2.7 For orphan medicinal products, the periodicity of the RPS will be as follows:8.2.7.1 Semi-annual the 2 first years.8.2.7.2 Year later.8.2.8 The RPS of drugs and vaccines marketed in the national territory without with SRAM/AEFI/EA reports or any other

security problem related to the use of medicines and vaccines in Mexico, must include a document that describes the additionalactivities that ensure the obtaining the missing information, which sorwill apply to the first RPS; should be continued with report tozero, should clearly justify by the holder of the registration and the CNFV define together with the owner of the register, additionalmeasures.

8.2.9 Medicines and vaccines that have sanitary registration and have not been sold in the country, must be sent to the CNFVformat of not marketing in national territory. This format is be put by a unique occasion for the entire time that lasts not marketing,

and must inform the home of marketing in the corresponding RPS.8.2.10 Periodicity.8.2.10.1 When a drug or not marketed vaccine begin marketing, you must deliver your RPS compliance with the content

established in section 8.2.3, of this standard, in the periods of specified in section 8.2.4 of this standard information and shipping.For fulfillment of the periodicity of submission, is taken as the basis date of marketing in the country. The RPS may beaccompanied by international safety information and the reporting when you apply.

8.3 safety in clinical studies report8.3.1 This point applies to all clinical trials, sponsored or not, including both the of bioequivalence, as to the pharmacovigilance

who have at least one site or research centre in Mexico.8.3.2 All institutions or establishments that carry out research for researchers or health independent to carry out clinical trials

with drugs and vaccines, must write reports of safety of clinical studies of monitoring or safety of final clinical trials reports.8.3.3 Submission to the CNFV of the safety of trials, both tracking reports as final, must be through the CIS, in accordance with

the following:8.3.3.1 In the case of studies sponsored by record owners or their legal representatives, the submission should be performed

by the holder of the registration or authorized this person.8.3.3.2 Studies on the initiative of the researcher, the submission should be performed by the principal investigator responsible

for the study authorized or authorized person.8.3.3.3 Periodicity in delivery times:8.3.3.3.1 Issue a report of follow-up each year from the first authorization security national study.8.3.3.3.2 To bioequivalence studies must only submit the final report, according to the established in the "", published by the

CNFV at http:// Guide for pharmacovigilance in clinical researchwww.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia?state=draft.

8.3.3.3.3 Issue a notice of termination of the clinical stage of the study.8.3.3.3.4 Issued a report of final security in the following cases:8.3.3.3.4.1 In the case of cancellation or final discontinuation of study.8.3.3.3.4.2 Upon completion of the analysis of the information collected during the study completed.8.3.4 The contents of reports of safety of clinical studies should comply with Guide of pharmacovigilance in clinical research

published by the CNFV in http://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requerimientos-de-farmacovigilancia?state=draft, for this purpose.

8.4 PMR8.4.1 Develop or update a PMR for drugs and vaccines when:8.4.1.1 Register a drug or vaccine in the country.8.4.1.2 Prompted the renewal of registration of a drug or vaccine in the country (applies for the médicamentyou and vaccines

than prior to the proFacebook have not yet submitted a PMR).8.4.1.3 Prompted the renewal of registration of a drug or vaccine in the country in which there is evidence of a concern or issue

of security at national or international level that affects the balance benefit risk.8.4.1.4 For orphan drugs.8.4.1.5 The health authority so requests based on a concern for safety or subject of safety.8.4.1.6 The registration holder or his legal representative has identified a concern of safety or security issue that requires it.8.4.1.7 There are changes in the health registry that impact on the therapeutic scheme or via of Administration.8.4.2 In the case of registration of new molecule:8.4.2.1 The applicant for the registration shall deliver to the CNFV the PMR for review, prior to the request of technical meeting

with the CMN.8.4.2.2 The CNFV emits a predictamen to the applicant concerning the analysis of the PMR and if required proposed

amendments. In addition, technical opinion during the relief of the meeting of the CMN.8.4.2.3 The registration applicant may enter modifications to the meeting after PMR with the CMN.8.4.2.4 The registration applicant may submit its request for registration while to the PMR adjustments requested by the CNFV

for approval, is not determinant for the issuance of the corresponding registration.8.4.2.5 The CNFV will deliver to CAS and to the applicant for the registration the opinion final of the PMR.8.4.3 In accordance with the risk of each drug or vaccine, the PMR may be 3 categories, and the information contained therein

shall be in accordance with the "Pharmacovigilance Guide for making PMR", published by the CNFV inhttp://www.gob.mx/cofepris/documentos/guias-lineamientos-y-requirements-of-pharmacovigilance? state = draft, and they mustsubmit at least the following information:

8.4.3.1 category I:8.4.3.1.1 Product description.8.4.3.1.1.1 Distinctive appellation.8.4.3.1.1.2 Generic name.8.4.3.1.1.3 Pharmaceutical form and formulation.8.4.3.1.1.4 Therapeutic.8.4.3.1.2 Safety.8.4.3.1.2.1 Description of populations for which there is no safety information.8.4.3.1.2.2 Available post-marketing safety information.8.4.3.1.2.3 Uses outside authorized indication, overdose, illegal, use safety information medication errors.8.4.3.1.2.4 Overview of the security issues.8.4.3.1.2.5 List of important risks.8.4.3.1.2.6 International alerts.8.4.3.1.3 Pharmacovigilance plan.8.4.3.1.3.1 Routine activities.8.4.3.1.4 Risk minimization plan.8.4.3.1.4.1 Routine activities.

8.4.3.2. category II:8.4.3.2.1 Product description.8.4.3.2.2 Safety. 8.4.3.2.3 Pharmacovigilance plan.8.4.3.2.3.1 Routine activities.8.4.3.2.3.2 Additional activities (not including trials).8.4.3.2.4 Risk minimization plan.8.4.3.2.4.1 Routine activities.8.4.3.2.4.2 Additional activities.8.4.3.3. category III:8.4.3.3.1 Product description.8.4.3.3.2 Safety.8.4.3.3.3 Pharmacovigilance plan.8.4.3.3.3.1 Routine activities.8.4.3.3.3.2 Additional activities (can include pharmacovigilance studies or clinical).8.4.3.3.4 Risk minimization plan.8.4.3.3.4.1 Routine activities.8.4.3.3.4.2 Additional activities.8.4.4 In accordance with the type of drug or vaccine, and considering the safety profile and the corresponding risk assessment,

drugs or vaccines, in general, will attend the following categories:8.4.4.1 category I:8.4.4.1.1 Generics, including its reference medicine.8.4.4.2. category II:8.4.4.2.1 Marketed drugs and vaccines, of which there is a concern or issue of security at national or international level that

affect the risk/benefit balance.8.4.4.2.2 Drugs and vaccines with modifications that impact on the therapeutic scheme and/or way of Administration.8.4.4.2.3 New, biological or biotechnological molecules that have a sanitary registration issued by a regulatory authority

recognized by COFEPRIS and information from clinical studies that establish a favorable safety profile.8.4.4.2.4 Orphan drugs that have a sanitary registration / recognition of orphan issued by a regulatory authority recognized by

COFEPRIS and information from studies clinicians who establish a favorable safety profile.8.4.4.2.5 Drugs and vaccines of which is already known its safety in others profile conditions and who have suffered

modifications that impact on their security.8.4.4.3 Category III:8.4.4.3.1 New, biological or biotechnological molecules that do not have a sanitary registration issued by a recognized by

COFEPRIS regulatory authority and information from clinical studies do not allow to establish a favorable safety profile.8.4.4.3.2 Orphan drugs that do not have a registration / recognition of orphan issued by a recognized by COFEPRIS regulatory

authority and information from studies clinicians do not allow to establish a favorable safety profile.8.4.4.3.3 Drugs and vaccines marketed in Mexico where there is evidence of a risk to national or international level which can

potentially exceed the benefit.8.4.5 In accordance with the applicable provisions, the term of submission of the PMR, will be at performed in accordance with

the following:8.4.5.1 For drugs and vaccines that require going through the CMN, the PMR must be served to the CNFV, later the same day

requested the meeting before the CMN.El CNFV will issue a predictamen or opinion to the applicant derived from analysis of the PMR and in case of required, also

require amendments.8.4.5.2 For drugs and vaccines that do not require going through the CMN, the PMR 90 is to be delivered business days prior

to the application for registration, approval of the PMR is not driving the corresponding registration application.8.4.5.3 For drugs and vaccines that have a health record and that have not yet submitted a PMR and requested its extension,

the applicant must submit to the CNFV the PMR later the same day of request their extension.8.4.5.4 For drugs and vaccines that have a registration and which have submitted a PMR and requested its extension, the

applicant must submit to the CNFV update of the PMR's way five-year based on the date of adoption of the current PMR. 8.4.5.5 For drugs and vaccines that have a registration and which have submitted a PMR and request a modification to the

registration conditions, listed in the agreement by which is unveil procedures which may apply together with the extension ofregistration, thus as the requirements to do so, resulting in the extension of the registration, shall be of filed the CNFV the PMR'sway five-year based on the date of adoption of the previous PMR or existing.

8.4.5.6 For drugs and vaccines that have a health record and that have not yet submitted a PMR and request a modification tothe registration conditions, listed in the agreement by which occur to know the procedures which may be requested together withthe extension of health, registration as well as the requirements to do so, resulting in the extension of the registration, shall be ofpresent to the CNFV the PMR at the latest the day of the request for modification.

8.4.5.7 All PMR accepted by the CNFV will have a standard period of 5 years. Reports of the activwill be additional idadesnwith annually until the end of the scheduled period the which will depend on the characteristics and the level of risk of eachmedication.

8.4.5.8 Every 5 years must be presented an update of the PMR, taking as a cut-off date the date of adoption of the first PMR.With a period of 60 calendar days after the date of Court for the delivery of the document to CNFV.

8.5 Report of pharmacovigilance.8.5.1 For the request for extension, the holder of the registration or his legal representative shall request the

Pharmacovigilance report, based on the resolution of information security submitted to the CNFV, 240 to 360 calendar days priorto the expiry of his registration.

8.5.2 For paperwork associated with modifications resulting in the extension of the registration, shall be subject to the

provisions of the agreement whereby are given to know the procedures that you can obtain of jointly with the extension ofregistration, as well as the requirements for that purpose, issued and published by the health authority, and the holder of theregistration or his legal representative shall request the report of pharmacovigilance to the CNFV and shall attach to the issue therequest to the CNFV of the report pharmacovigilance.

9. agreencia with international standardsThis standard is partially equivalent to the international standards:9.1 ICH-E2B. Electronic Transmission of Individual Case Safety Reports, 2015,

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002767.pdf.9.2 EMA. Guideline on good pharmacovigilance practices. "Definitions", 2014.9.3 EMA. Guideline on good pharmacovigilance practices. Module V "Risk Management Systems", 2014.9.4 EMA. Guideline on good pharmacovigilance practices. Module VI "Management and reporting of adverse reactions to

medicinal products", 2014.9.5 EMA. Guideline on good pharmacovigilance practices. Module VII "Periodic Safety Report", 2014.9.6 EMA. Guideline on good pharmacovigilance practices. Module XVI "Risk minimization measures: selection of tools and

effectiveness indicators", 2014.9.7 ICH-E2E. Pharmacovigilance Planning. International Conference on Harmonisation of technical requirements for

registration of pharmaceuticals for human use, 2004.9.8 ICH-E6. Good Clinical Practice: Consolidated Guidance. International Conference on Harmonisation of technical

requirements for registration of pharmaceuticals for human use, 1996.9.9 ICH E2A. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. International Conference

on Harmonisation of technical requirements for registration of pharmaceuticals for human use, 1994.10. Bibliografia10.1 The Uppsala Monitoring Centre / WHO Collaborating Centre for International Monitoring Centre. "" Glossary of terms used

in pharmacovigilance [Online] < http://www.who-umc.org > [query: March of 2016].10.2 Meyboon RHB, Hekster YA, Egberts AGC, Gribnau FWJ, Edwards go. Causal or Casual. Drug Safety. 1997; 17 (6): 374-

389.10.3 The Uppsala Monitoring Centre / WHO Collaborating Centre for International Monitoring Centre. "How do we identify the

risks of the drugs? " " " , Bulletin point of view, part 1, page 11, 2003.10.4 Pan American Health Organization. " " Good Pharmacovigilance Practices for the Americas " " . Washington, 2010.

(PARF-network technical paper No. 5).10.5 Good Pharmacovigilance Practices for the pharmaceutical drug industry of use Human . Document approved by the

Technical Committee of inspection on June 19, 2002.10.6 The importance of pharmacovigilance. WHO, 2002.10.7 Rules and procedures of the Cuban system of pharmacovigilance, 2012.10.8 Rehan H.S, et al, Physician ' s guide to Pharmacovigilance: terminology and causality assessment.

European Journal of Internal Medicine 20 (2009) 3-8.10.9 Data analysis of adverse reactions prepared by Luis M. Miller (Moose engineering) Association of the Spanish society of

hypertension, Spanish League for the fight against blood pressure blood May 2004. In line. http://www.seh-lelha.org/pdf/ram.pdf[access March 2017].

10.10 Guidance for Industry Development and Use of Risk Minimization Action Plans U.S. Department of Health and HumanServices Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation andResearch (CBER) March 2005, FDA.

10.11 Rodríguez J.M.; C. Aguirre; Garcia M.; PALOP R. pharmacovigilance. Hospital pharmacy chapter 2.10. In line.http://www.sefh.es/bibliotecavirtual/fhtomo1/cap210.pdf [access March 2017].

10.12 ICH E2C. Guideline on periodic benefit-risk evaluation report. International Conference on Harmonisation of technicalrequirements for registration of pharmaceuticals for human use, 2012.

10.13 World Health Organization. Manual on global surveillance of adverse events following immunization. Geneva, WHO,2014.

10.14 World Health Organization. Causality assessment of an adverse event following immunization (AEFI): user manual forthe revised WHO classification. Geneva, WHO, 2013.

10.15 Ministry of health, National Centre for the health of children and adolescents. Manual of events allegedly attributable tothe vacunation or immunization. Mexico, June 2014.

10.16 Pan American Health Organization World of the Health Organization. Regional Platform on access and innovation forhealth technologies (PRAIS), Washington, PAHO, 2014.

10.17 United States Pharmacopoeia Mexicans. Supplement for establishments dedicated to the sale and supply of drugs andother health supplies, 5th Edition. Mexico, 2014.

10.18 World Health Organization. Global Manual on Surveillance of Adverse Events Following Immunization. Draft v2.0, 3February 2014.

1019 Pan American Health Organization. Module IV: Technical and clinical aspects of events supposedly attributable tovaccination or immunization (AEFI). Washington, D.C., PAHO, 2007.

10.20 Guideline on good pharmacovigilance practices (GVP) Annex I - DEFINITIONS (Rev 3) 15 April 2014 876333-EMA-2011Rev 3

10,21 World Health Organization / Uppsala monitoring centre. Surveillance of safety of drugs. Guide for installation andcommissioning of a pharmacovigilance centre. 2001http://www.essalud.gob.pe/ietsi/pdfs/informacion_tecnica/OMS_guia_farmacovigilancia.pdf

11. observance of the standardMonitoring of compliance with this standard corresponds to the Department of health through the Federal Commission for

protection against health risks and the Governments of the federative entities in their respective areas of competence, whose staffperform verification and monitoring that are required.

1 2. conformity assessmentThe conformity assessment can be requested by the health Director, representative or legal the person who has the powers to

do so, before the competent authority or the accredited persons and approved for such purposes.

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13 validityThis standard will come into force 180 days after their publication in the journal natural Oficial of the Federation.

TRANSIENT

The first. The entry into force of this standard leaves without effect the Mexican official norm NOM -220-SSA1-2012,installation and operation of pharmacovigilance, published in the official journal of the Federation of January 7, 2013.

Second. For only marketed products in Mexico, you will be accepted only during a Five-year RPS to reports which breakpoint(based on the last accepted RPS) is prior to the 1 of July 2015. Must then follow with triennial RPS.

3rd. For products that are marketing the country to date entry into force of this standard provides for the presentation of RPScan continue with its date of cut-off point (date of registration in Mexico) that reports were delivered previous; if you opt for arescheduling, it shall inform the CNFV prior to the entry into force of this standard.

Quarter. For medicinal products that have health record and that have not yet submitted a PMR to the entry into force of thisregulation, must present their first PMR to when requesting your modification with extension or extension.

City of Mexico, June 2, 2017-the Federal Commissioner for the protection against risks Health and Chairman of the NationalAdvisory Committee for the standardization of regulation and health promotion, Julio Salvador Sánchez y Tepoz.-rubric.

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