Royal Decree 711/2002, 19 July, Which Regulates Pharmacovigilance Of Medicinal Products For Human Use.

Original Language Title: Real Decreto 711/2002, de 19 de julio, por el que se regula la farmacovigilancia de medicamentos de uso humano.

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Law 25/1990, of 20 December, medication, regulates pharmacovigilance in its title II, chapter VI, contemplating the Spanish pharmacovigilance system as a decentralized structure that integrates the activities of the health authorities in this matter and coordinates the Ministry of health and consumption. It establishes the obligation of health professionals collaborate with such a system.


The ultimate aim of pharmacovigilance is to continuously provide the best possible information about the safety of the drugs, allowing for the adoption of appropriate measures and, thus, make the drugs available in the market submit a relationship favourable to the population benefit authorized conditions of use.


Pharmacovigilance is a responsibility shared by the competent authorities, the marketing authorisation holders and health professionals. It is essential, therefore, provide a normative framework that define the obligations of each of the agents involved and ensure effective communication between them, taking into account the administrative structure of the State and belonging to the European Union.


In this sense, the Royal Decree 767/1993, of 21 may, which regulates the evaluation, authorisation, registration and terms of dispensation of pharmaceutical and other medicinal products for human use manufactured industrially, joined our legal system may 20 Council Directive 75/319/EEC on the approximation of the laws, regulations and administrative provisions on pharmaceutical specialities as well as their subsequent amendments.


These directives have come to be modified at the same time by Directive 2000/38/EC of the Commission of 5 June, that amending chapter V bis "Pharmacovigilance" of Council Directive 75/319/EEC, resulting from the application to the interpretation of the definitions and principles of that and, therefore, the present Royal Decree, the orientations of the European Commission on collection verification and presentation of adverse reaction reports that are published in volume 9 of the rules governing medicinal products in the European Union. The incorporation of the directive into the legal system internal, together with the development of the provisions of Chapter VI of title II of law 25/1990, of 20 December, medication, concerning the Spanish system of pharmacovigilance, make it necessary to its regulation in a single text by using this standard, with the consequent repeal of forecasts collecting in this area by the Royal Decree 767/1993 , May 21, in the wording given by the Royal Decree 2000 / 1995 of 7 December, amending Royal Decree 767/1993, of 21 may, which regulates the evaluation, authorisation, registration and terms of dispensation of pharmaceutical and other medicinal products for human use manufactured industrially.


Meanwhile, Royal Decree 520/1999, of 26 March, which approves the Statute of the Spanish medicines agency, develops in part this autonomous body functions in pharmacovigilance and safety Committee of drugs for human use as a dependent of that College.


This Royal Decree, which has the status of legislation on pharmaceutical products in accordance with article 149.1.16. a of the Constitution, develops chapter VI of title II of law 25/1990, of 20 December, medication, finding its enabling regulations in the final disposition of the Act, and incorporates into domestic law Directive 2000/38/EC of the Commission 5 June, is amending chapter V bis "farmacovigilancia" of the Directive 75/319/EEC of the Council on the approximation of the laws, regulations and administrative provisions on proprietary medicinal products.


By virtue, on the proposal of the Minister of health and consumption, prior approval of the Minister of public administration, heard the autonomous communities and sectors affected, according to the Council of State and after deliberation by the Council of Ministers at its meeting of July 19, 2002, D I S P O N G O: chapter I General provisions article 1. Scope of application.


The provisions of this Royal Decree apply to the pharmacovigilance of medicinal products for human use, as activity of public health aimed at the identification, quantification, evaluation and prevention of risks associated with the use of such drugs.


Article 2. Definitions.


A_efectos_de this Royal Decree, means: to) "System Spanish pharmacovigilance of medicinal products for human use": decentralized structure which integrates health administrations activities to collect and prepare information on adverse drug reactions, coordinated by the Ministry of health and consumption, through the Spanish Agency of medicines.


(b) "program or system of notification spontaneous,": pharmacovigilance method based on communication, collection and evaluation of reports of suspected adverse drug reactions, carried out by a health professional, including those arising from dependence on drugs, abuse and misuse of medicines.


(c) "adverse reaction": any response to a medicinal product which is noxious and unintended and which occurs at doses that are normally applied in man for the prophylaxis, diagnosis or treatment of disease or for the restoration, correction or modification of physiological functions.


(d) "serious adverse reaction": an adverse reaction which results in death, may endanger the life, requires the hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or a disability, or is a congenital anomaly or birth defect. For the purposes of notification, they will try also how serious those suspected adverse reactions that are considered to be important from a medical point of view, although they do not meet the above criteria.


(e) "unexpected adverse reaction": any adverse reaction, the nature, severity or consequences are not consistent with the information described in the datasheet.


((f) "periodic safety report": the report containing the records referred to in article 8.g) of this Royal Decree.


(g) "study on post-authorisation": any study carried out during the commercialisation of a medicine according to the conditions of your authorized technical sheet or in normal conditions of use.


(h) "post-authorisation safety study": Studio pharmacoepidemiological or clinical trial carried out in accordance with the provisions of the marketing authorization, conducted with the purpose of identifying and quantifying the risks associated with the authorized medicinal products.


(i) ' drug abuse': the deliberate, persistent or sporadic excessive use of medication which is accompanied by harmful physical or psychological effects.


(j) "yellow card": form for the reporting of suspected adverse reactions, distributed by the competent bodies on pharmacovigilance of the autonomous communities to health professionals.


(k) "Good Pharmacovigilance Practices": set of standards or recommendations designed to ensure the authenticity and quality of the data collected on pharmacovigilance, allowing to assess in every moment risks attributable to medication; the confidentiality of information relating to the identity of persons who have presented or reported adverse reactions; and the use of uniform criteria in the evaluation of notifications and the generation of warning signs.


Article 3. Sources of information on pharmacovigilance.


Information about the risks associated with the medications may come from the following sources: a) spontaneous reporting individual cases of suspected adverse reactions by health professionals.


(b) studies post-authorisation, including Pharmacoepidemiologic studies.


(c) databases sanitary computerized.


(d) pre-clinical information on animal experiments and clinical trials of a drug information.


(e) information related to manufacturing, conservation, sale, distribution, dispensing and habits of use, prescription and administration to patients of a drug.


(f) publications in the medical literature.


(g) other sources of information, such as those relating to the misuse and abuse of medications, which may have an impact on the evaluation of the benefits and risks of medicines.


(h) other health authorities and international health organizations.


Chapter II of the Spanish pharmacovigilance system of medicinal products for human use article 4. Agents of the Spanish pharmacovigilance system of medicinal products for human use.


1 the Spanish pharmacovigilance system of medicinal products for human use is composed by: a) the Spanish medicines agency.


(b) the competent bodies pharmacovigilance of the autonomous communities.


(c) health professionals.


2. the Technical Committee of the system Spanish pharmacovigilance, as a body composed of the Spanish Agency of medicines and the competent bodies in pharmacovigilance of the autonomous communities, will unify the criteria of performance and evaluate the signals generated by the Spanish pharmacovigilance system of medicinal products for human use.



Article 5. Functions of the Spanish Agency of medicines in pharmacovigilance.


The functions of the Spanish medicines agency are: to) plan, coordinate, evaluate and develop the Spanish pharmacovigilance system of medicinal products for human use, as well as the tasks of its technical Committee, in accordance with "good practices of pharmacovigilance from the Spanish pharmacovigilance system" drawn up by the Technical Committee and published by the Ministry of health and consumption.


b) establish, in collaboration with the autonomous communities, a network of data processing which allow the competent bodies pharmacovigilance of the autonomous communities have accessible telematics all the information collected by the Spanish pharmacovigilance system.


(c) to manage the database of the system Spanish of pharmacovigilance of medicinal products for human use, ensuring at all times their availability and updating, monitoring their safety and ensuring data confidentiality and integrity for data transfer processes.


(d) Act as a centre of reference in the Spanish system of pharmacovigilance medicines marketing authorisation holders.


(e) immediately available to the marketing authorisation holder, and in any event within fifteen calendar days following its receipt, notifications about suspected adverse reactions serious that have occurred in Spain and that drugs which are holders are involved.


Any other information concerning pharmacovigilance not referred to in the previous paragraph will have to be expressly requested by the person concerned in accordance with the procedure laid down for that purpose.


f) transmit to the European Agency for the evaluation of medicinal products and the Member States immediately, and in any event within fifteen calendar days following its receipt, notifications about suspected adverse reactions serious have occurred in Spain.


Such communication shall be effected through the network of data processing to the European Agency for the evaluation of medicinal products established in collaboration with the Member States and the European Commission.


(g) promote the creation of database health computer that can serve as a source of information for Pharmacoepidemiologic studies.


h) provided for, in this matter, by Royal Decree 520/1999, of 26 March, which approves the Statute of the Spanish medicines agency.


(i) any other function that may be necessary in the field of pharmacovigilance, and that should be exercised by the Spanish Agency of medicines.


Article 6. Functions of the competent bodies in pharmacovigilance of the autonomous communities.


1. to the competent bodies in pharmacovigilance of the autonomous communities corresponds them implement, develop and promote in its territory the spontaneous reporting program, as well as other programmes, in accordance with "good practices of the Spanish system of pharmacovigilance pharmacovigilance".


2. in particular, it is receiving, evaluating and processing suspected adverse reactions produced in their territory and communicated by health professionals or by the pharmaceutical industry, as well as from the scientific literature and post-authorisation studies, where appropriate. Suspected serious adverse reactions should register in the database of the Spanish pharmacovigilance system within a maximum period of ten calendar days from their receipt.


Article 7. Obligations of health professionals.


Health physicians, pharmacists, nurses and other professionals have an obligation of: to) notify all suspected adverse reactions which have knowledge during its usual practice and send it as soon as possible to the competent body for pharmacovigilance of the corresponding Autonomous Community, through the form of collection of suspected adverse reactions ("yellow card").


(b) retain the clinical documentation of the suspected adverse reactions to drugs, in order to complete or to track, if necessary.


(c) cooperate with the pharmacovigilance of medicinal products for human use Spanish system technicians, providing the necessary information that they are requested to expand or complete information about suspected adverse reactions.


(d) be informed about the safety data on drugs that usually prescribe, dispense or administer.


(e) collaborate with responsible for pharmacovigilance of holders of marketing authorisations, where a suspected adverse reaction to one of its pharmaceutical specialties, providing the information required for subsequent notification to the Spanish pharmacovigilance system.


(f) collaborate, as experts, with the Spanish Agency of medicines and the competent bodies of the autonomous communities, in the evaluation of the problems of safety of medicines for human use.


Chapter III article 8 marketing authorisation holders. Obligations of the holder of the marketing authorisation.


The holder of the marketing authorization, in accordance with the "good practices of pharmacovigilance to the pharmaceutical industry", published by the Ministry of health and consumption, must: to) keep detailed records of all suspected adverse reactions occurring in Spain, the European Union or a third country.


b) record and communicate to the Spanish Agency of medicines and the competent body on pharmacovigilance of the autonomous community concerned, immediately, and in any event within fifteen calendar days following the receipt of the information, all suspected serious adverse reactions that occur in Spain and which have been notified him by health-care professionals , or any other reaction suspected adverse serious to occur in Spain and which may be expected reasonably to have knowledge.


c) guarantee that all suspected adverse reactions serious and at the same time unexpected drugs authorized in Spain that occur outside the European economic area, which was aware through a health services professional, are communicated to the Spanish medicines agency immediately, and in any event within fifteen calendar days following the receipt of the information.


(d) to track the scientific literature world, in order to identify the published cases of adverse reactions in which there are reasonable suspicions that the deceased is an active ingredient of a drug whose authorization to market in Spain is holder. (These cases are communicated in accordance with the criteria specified in paragraphs b)) and (c) of this article.


((e) ensure that all suspected serious adverse reactions that occur during the course of a post-authorisation study, and which can be expected reasonably have knowledge, they are communicated using the criteria specified in paragraphs b)) and (c) of this article and in accordance with the conditions that establish sanitary administrations according to provisions of article 18.2 of this Royal Decree.


(f) ensure, in the case of medicinal products for human use reference Member State are Spain, evaluated within the scope of the community consultation procedure, that has been authorized by the mutual recognition procedure, or which have been subject to Community decision in accordance with the provisions of article 56 of the Royal Decree 767/1993 of 21 may, which regulates the evaluation, authorisation, registration and terms of dispensation of pharmaceutical and other medicinal products for human use manufactured industrially, that all suspected serious adverse reactions occurring in the territory of the European Union to communicate in the format and at intervals to indicate the Spanish medicines agency.


(g) submit to the Spanish medicines agency records of all suspected adverse reactions in the form of periodic safety report.


This presentation must be made immediately at the request of the Spanish Agency of medicines and, also, from time to time in accordance with the following timetable, unless other requirements have been established as a condition for granting marketing authorization: every six months during the first two years after authorization, annually for the next two years and at the time of request is the first five-year renewal. Thereafter the periodic safety report will be presented at intervals of five years, together with the application for renewal of the authorization.


The periodic safety report shall include a scientific evaluation of the benefits and risks associated with the drug.


Once granted marketing authorization, the holder may request the amendment of the periods referred to in the previous paragraph, in accordance with the procedure laid down in the Regulation (EC) 541/95 of the Commission, of 10 March, concerning the consideration of amendments to the terms of marketing authorisations granted by the competent authority of a Member State.



This timetable will also start from the date of approval of changes in the composition of new therapeutic indications of new formats of administration or substantial changes to the conditions of authorisation.


(h) conduct, when required, studies post-authorisation to confirm, quantify or characterize potential risks, or provide new scientific information on the relation benefit of drugs authorized in Spain.


(i) carry out a continuous assessment of the relationship benefit from drugs that have authorized in Spain and immediately inform the Spanish medicines agency new information that may influence the global assessment benefit or may require the modification of the sheet, prospect or both.


Article 9. Person responsible for pharmacovigilance.


1. the holder of the authorization of marketing of a medicinal product for human use must have in Spain, permanent and continuous way of properly qualified as responsible for pharmacovigilance. The holder of the marketing authorization shall communicate to the Spanish Agency of medicines, as well as to the competent organs in pharmacovigilance in the autonomous region where it is situated, the name of this responsible. The Spanish medicines agency will keep a record of these decision makers.


2 the person responsible for pharmacovigilance shall have the following functions: to) create and maintain a system to collect, treat and assess the information about all suspected adverse reactions reported to the personnel of the company and doctors visitors, so it's accessible at least at one place of the European Union.


b) prepare and submit to the Spanish medicines agency periodic safety reports that referred to article 8.g) of this provision.


(c) make giving an answer quick and complete to any request for additional information from the Spanish medicines agency necessary to evaluate the benefits and risks of a drug, including information on the volume of sales or prescriptions of the medicinal product concerned.


(d) provide any other information relevant to the evaluation of the benefits and risks associated with a drug, including information on post-authorisation safety studies of the Spanish medicines agency.


Article 10. Information and modification of the conditions for approval, at the request of the holder, for security reasons.


1. the marketing authorisation holder is obliged to spread among at least health professionals the datasheet of the specialty, together with the information referred to in paragraph 5 of article 19 of law 25/1990 of 20 December, medication. In addition, you must send to the autonomous communities sheet authorized by the Spanish Agency of medicines.


2. when at the discretion of the Spanish medicines agency deemed necessary that the holder of the marketing authorization informs healthcare professionals of new data concerning safety aspects of a drug, and decides to transmit single letter each concerned health professional, you must agree the text previously with the Spanish medicines agency, and incorporated into the envelope a hallmark indicating the nature of the information that it contains.


3. in accordance with article 33 of law 25/1990 of 20 December, the drug, when the holder of an authorization of marketing of a drug know new relevant information affecting the safety of the drug, including its knowledge through circular or individual notification of the Spanish medicines agency, you should update record authorization and registration pursuant to scientific and technical progress through the procedures of modification of the conditions of authorization of proprietary medicinal products for human use, including payment of the corresponding fee.


Breach of this duty may result in suspension or revocation, in accordance with the provisions of article 13 of the present Royal Decree.


4. without prejudice to paragraph 3, whenever he considers it appropriate the Spanish medicines agency may ask the holder of the marketing authorisation, through your head of pharmacovigilance, an updated report of assessment benefit.


Chapter IV article 11 administrative intervention. Body advice and participation of experts in the evaluation of the safety of the drugs.


1. in accordance with provisions in the Real Decree 520/1999, of 26 March, which approves the Statute of the Spanish medicines agency, this will be with the Committee of safety of medicines for human use for their advice in the field of pharmacovigilance.


2. the Spanish Agency of medicines shall draw up a list of experts in safety of medicines, which will include, among others, the technicians of the Spanish pharmacovigilance system of medicinal products for human use designated by the competent bodies in each autonomous community. These experts, at the request of the Spanish medicines agency, will participate in the evaluation of problems of security, post-authorisation studies and application for alteration of the technical file.


Article 12. Alteration of the authorization regime.


The Spanish medicines agency, when of the evaluation of pharmacovigilance data is infer reasons of public interest, protection of the health or safety of persons, can restrict the conditions of authorisation of a medicinal product, and set any reservations or restrictions on the scope of use of the same listed below: a) hospital use.


(b) hospital diagnosis or prescription by doctors.


(c) special control medication.


Article 13. Suspension or revocation of the authorization.


1 the Spanish medicines agency, in accordance with the evaluation of pharmacovigilance data, may temporarily suspend or permanently revoke the authorisation of a medicinal product when: a) turns out to be unsafe or harmful in the normal conditions of employment.


(b) is not to be therapeutically effective.


(c) for any other reason to suppose a foreseeable risk for the health or safety of persons.


(d) show a relationship benefit unfavorably, in the terms provided in article 10(3) of law 25/1990 of 20 December, of the drug.


2. for reasons of public health, and until the procedure of suspension or revocation is resolved, may impose is a preventive suspension by a reasoned ruling, even immediately before the initiation of proceedings. In these cases, the person concerned shall withdraw from the market the product at its expense, without prejudice to a performance by the Spanish medicines agency when the urgency of the case requires it. Costs that cause these measures shall be borne by the person concerned, without that it has, in any case, sanctioning character.


Article 14. Procedure for the alteration of the regime, suspension or revocation of the marketing authorisation.


1. the Agency Spanish of the medication may agree to the alteration of the system of authorization of a drug that may entail a restriction of the relevant use or the conditions of authorization, or the suspension or the revocation of such authorization by the causes provided for in articles 12 or 13 of the present Royal Decree, as appropriate, in accordance with the following procedure (: a) the Spanish medicines agency will ask the holder of the marketing authorisation an expert report that evaluates the relationship benefit of medication for conditions of use authorized in Spain, including proposed measures for risk reduction. This report shall comply with the structure and issues that are specified in the request of the Spanish Agency of medicines.


The report must be submitted within a maximum period of sixty days from the receipt of the request.


(b) in the light of the expert report, the Spanish medicines agency shall draw up an evaluation report of the problem of security within the period of thirty days, and forward it to the Security Committee of medicines for human use.


(c) the Committee on safety of medicines for human use will be required but nonbinding opinion.


(d) the Spanish Agency of the medication, after hearing the person concerned, issue resolution the remedies, and shall notify it the interested party within thirty days from the issuance of the above-mentioned opinion or, where appropriate, of the notification of the Community decision referred to in the following paragraph.


Without prejudice to the foregoing, in specific cases where the interests of the European Union are at stake, and prior to the resolution of the Spanish medicines agency, you may refer the matter to the Committee for proprietary medicinal for the adoption of a community decision.


Such a request be made by the holder of the authorization or the Spanish medicines agency after the opinion of the Security Committee of drugs for human use. In any case, the request must be accompanied all available information.



(e) in the case of the alteration of the system of authorization procedure, the resolution will indicate changes that must be entered on the sheet, prospect, labels and scope of use of the drug, as well as other measures to reduce the risk and inform health professionals and users.


In accordance with these provisions, the holder of the marketing authorization shall request the timely amendment of the conditions of authorisation of the medicinal product, in accordance with the procedures laid down in the Royal Decree 767/1993, May 21, and the circular on amendment of the conditions of authorization of proprietary medicinal products for human use, including payment of the corresponding fee.


(f) the suspension, revocation, and alteration of the system of authorization, resolutions in which may affect public health in third countries, they shall bring to the attention of the World Health Organization.


2. the procedure laid down in the preceding paragraph shall not apply to medicines authorised through the centralised procedure laid down in Regulation (EEC) 2309/93 of the Council of 22 July, which lays down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of medicinal products which will be governed by its specific regulations.


Article 15. Communications and measures are precautionary.


1. If the Spanish Agency of medication, in view of the pharmacovigilance data, considers that a marketing authorisation should be subject to suspension, revocation or modification that involves a relevant restriction of the use of the medicinal product, it shall immediately to the ministries of health of the autonomous communities, the European Agency for the evaluation of medicinal products, to the other Member States and the marketing authorization holder.


2. in urgent cases, the Spanish medicines agency may suspend the authorization of marketing of a drug reporting, at the latest the first working day following, the ministries of health of the autonomous communities, the European Commission, the European Agency for the evaluation of medicinal products, to the other Member States and the marketing authorization holder.


Article 16. Alteration of the regime of authorization, suspension and revocation of drugs authorized by the procedures of mutual recognition and the old community consultation procedure defined in the Royal Decree 767/1993, of May 21.


1. without prejudice to the provisions of article 14 of this provision, when the Spanish medicines agency, in accordance with the evaluation of pharmacovigilance data, considers necessary for public health reasons the alteration of the regime, suspension or revocation of the marketing authorisation of medicinal products authorised by the procedures of mutual recognition and the old community consultation procedure It must refer the matter to the Committee for proprietary medicinal for the adoption of a community decision.


2 notified the Community decision, without any further formality than the audience to the person concerned, the Spanish medicines agency will adopt and notify the timely resolution, with an indication of the resources, within the period of thirty days following notification of the Community decision.


3. in cases where a preventive suspension of the drug was justified, shall apply the provisions of article 13.2 of this Royal Decree and be informed of the reasons for this suspension, later than the working day following the adoption of the measure, to the ministries of health of the autonomous communities, the European Commission the European Medicines Evaluation Agency, the other Member States, and to the holder of the marketing authorisation.


Article 17. Communication to the autonomous communities, health professionals and citizens.


1. the Spanish Agency of medicines shall inform the autonomous communities and other responsible agencies concerning the adoption of the measures provided for in this chapter which, because of its relevance to human health, should be known to health professionals.


Administrations disseminated such information among health professionals which, both in public and in private, pursue their activities in its territory.


2. the Spanish Agency of medicines and the autonomous communities will get the citizens, in proper form, information about the risks of drugs that may have important implications for their health.


Chapter V of the studies post-authorisation article 18. Applicable regime.


1. Post-authorisation studies must have intended complement information obtained during the clinical development of drugs prior to their authorization. They are not planned, carried out or financed studies post-authorisation with the purpose of promoting the prescription of drugs.


2. observational type post-authorisation studies will take place in accordance with the conditions that establish sanitary administrations in the field of its competences.


3. without prejudice to the provisions of the preceding paragraph, the Spanish medicines agency will maintain a registry of proposed study post-authorisation of observational type, in accordance with paragraph 2, may require a prior authorization. For this purpose, the promoter of the study shall forward to the Spanish medicines agency a copy of the study protocol, and, when appropriate, should communicate the effective beginning of the study and submit monitoring reports and the final report.


4 when the study post-authorisation, in accordance with the provisions of article 59 of law 25/1990 of 20 December, the drug, has character of clinical trial and observational study does not, it is not governed by the provisions of this chapter, but it will you apply the specific regulation on clinical trials.


Sole additional provision. Character of legislation.


This Royal Decree is adopted in development of law 25/1990, of 20 December, medication, and has the character of law of pharmaceutical products for the purposes specified in article 149.1.16. of the Constitution.


Sole repeal provision. Repeal legislation.


Repealed articles 37 and 37 bis of Royal Decree 767/1993, of 21 may, in the wording given by the Royal Decree 2000 / 1995 of 7 December, amending Royal Decree 767/1993, of 21 may, which regulates the evaluation, authorisation, registration and terms of dispensation of pharmaceutical and other medicinal products for human use manufactured industrially as well as how many provisions of equal or lower rank to oppose provisions of this Royal Decree.


First final provision. Faculty of development.


It empowers the Minister of health to enact the provisions necessary for the correct application and development of this Royal Decree.


Second final provision. Entry into force.


This Royal Decree shall enter into force the day following its publication in the "official bulletin of the State".


Given in Madrid on July 19, 2002.


JUAN CARLOS R.


The Minister of health and consumption, ANA MARÍA PASTOR JULIÁN

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