GOVERNMENT OF THE REPUBLIC OF ARMENIA
DECSION
No 1138-N of 26 August 2010
ON APPROVING MЕCHANISMS FOR COOPERATION AND PROCEDURES FOR COORDINATION OF NATIONAL REGULATORY BODY AND INТERESTED BODIES ON ISSUES OF INTERNATIONAL HEALTHCARE (MEDICAL AND SANITARY) RULES, REPORTING AND EVALUATION SCHEME ON THE EVENTS REPRESENTING EMERGENCY SITUATION OF INTERNATIONAL SIGNIFICANCE IN THE SECTOR OF PUBLIC HEALTH AND EXAMPLES OF THE SCHEMES FOR ADOPTING THE DECISION APPLIED FOR EVALUATING AND REPORTING THE EVENTS WITH THE POTENTIAL TO GIVE RISE TO AN EMERGENCY SITUATION OF INTERNATIONAL SIGNIFICANCE IN THE SECTOR OF PUBLIC HEALTH
(Title supplemented by No 1505-N of 26 September 2024)
Based on point 5 of part 1 of Article 6 of the Law of the Republic of Armenia “On public healthcare”, the Government of the Republic of Armenia hereby decides:
(Preamble edited by No 1505-N of 26 September 2024)
1. To approve:
(1) Mechanisms for cooperation and procedures for coordination between the National Regulatory Body and Interested Bodies for International Healthcare (Medical and Sanitary) Rules, in accordance with Annex No 1;
(2) form in relation to the reporting of the events representing emergency situation in the sector of public healthcare, conditioned by biological, chemical and radiation factors, according to Annex No 2;
(3) scheme for the reporting and evaluation of the events representing emergency situation of international significance in the sector of public health, according to Annex No 3;
(4) examples of the schemes for adopting the decision applied for evaluating and reporting the events with the potential to give rise to an emergency situation of international significance in the sector of public health, according to Annex No 4.
2. Assign to the National Regulatory Body for International Healthcare (Medical and Sanitary) Rules:
(1) to develop, within three months after the entry into force of this Decision, and to submit to heads of Interested Bodies a sample procedure for reporting information to the person responsible for introducing International Healthcare (Medical and Sanitary) Rules when recording an event representing emergency situation in the sector of public health, conditioned by biological, chemical and radiation factors;
(2) to develop, within three months after the entry into force of this Decision, and to submit to the heads of Interested Bodies the form for provision of annual information on the policy, strategy and programmes planned and performed thereby in relation to biological, chemical and radiation factors and risks, being presented to the National Regulatory Body by each body before 1 February of each year, as well as the form for providing semester information on the issues regarding the adherence to the requirements of the rules and introduction of the rules in its system;
(3) to develop, within one year after the entry into force of this Decision, and to approve, in a prescribed manner, the list of all Interested Bodies for International Healthcare (Medical and Sanitary) Rules;
(4) to establish, within one year after the entry into force of this Decision, based on the joint orders of the heads of Interested Bodies, standard procedures prescribing the processes ensuring the mechanisms for cooperation for the National Regulatory Body and Interested Bodies, for performing coordination activities by the National Regulatory Body for International Healthcare (Medical and Sanitary) Rules.
3. This Decision shall enter into force on the day following its official promulgation.
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Prime Minister of the Republic of Armenia |
T. Sargsyan |
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10 September 2010, Yerevan |
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Annex No 1 to the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010 |
MECHANISMS AND COORDINATION PROCEDURES FOR COOPERATION BETWEEN NATIONAL REGUATORY BODY AND INTERESTED BODIES FOR INTERNATIONAL HEALTHCARE (MEDICAL AND SANITARY) RULES
I. GENERAL PROVISIONS
1. This Procedure shall establish the mechanisms and coordination procedures for cooperation between the National Regulatory Body and Interested Bodies for International Healthcare (Medical and Sanitary) Rules.
2. Within the meaning of this Decision:
(1) a public health emergency of international significance shall be an unusual event caused by biological, chemical, or radiation factors that may pose danger to public health for neighbouring States through the international spread of disease, poisoning or radiation or may require a coordinated international response;
(2) an unusual event shall be considered to be an event that arose from an unknown trigger, or where the source, transmitter or route of transmission is not typical to the event that caused the given trigger or is unknown, the course of events is more severe than expected (including morbidity or mortality), or the symptoms of the events differ from the usual symptoms typical of the given event, or the event is not typical to the area or season;
(3) an unexpected event shall be considered to be an event that occurred due to a disease agent, chemical, or radiation trigger that had already been eliminated in the country, or had not been previously recorded, or specialised bodies did not expect its appearance: outbreak, epidemic, explosion, leak, etc.
(4) the relation bore by the bodies to biological, chemical and radiation factors: direct or indirect relation to biological, chemical and radiation factors (practical, scientific, professional) during state border control of the Republic of Armenia or in the course of exercising its powers by the body within the territory of the country. The extent and scope of the relation shall be determined jointly by the given body, its superior organisation and the National Regulatory Body for International Healthcare (Medical and Sanitary) Rules (hereinafter referred to as “the National Regulatory Body”) during the process of developing the list of interested bodies for International Healthcare Rules by the National Regulatory Body, according to sub-point 2 of point 2 of this Decision;
(5) Interested Body: any organisation related to biological, chemical and radiation factors, regardless of organisational and legal form and departmental affiliation.
II. MECHANISMS FOR COOPERATION BETWEEN NATIONAL REGUATORY BODY AND INTERESTED BODIES FOR INTERNATIONAL HEALTHCARE (MEDICAL AND SANITARY) RULES
3. In order to organise cooperation between the National Regulatory Body and Interested Bodies, each body related to biological, chemical and radiation factors, regardless of organisational and legal form and departmental affiliation (hereinafter referred to as “the body”), shall, by the order of the head of the body, appoint a person responsible for the introducing the International Healthcare (Medical and Sanitary) Rules (hereinafter referred to as “the Rules”) (hereinafter referred to as “the responsible person”) within three months after the entry into force of this Decision and shall submit his or her contact details to the National Regulatory Body.
4. Within six months after the entry into force of this Decision, each body shall develop and, by order of the head of the body, shall introduce a procedure for reporting to the responsible person when recording an event caused by biological, chemical or radiation factors, including the events related to food safety (hereinafter referred to as “the event”), being guided by the sample procedure presented by the National Regulatory Body. The draft procedure shall be agreed with the National Regulatory Body, and a duplicate copy of the approved document shall be submitted to the National Regulatory Body.
5. The responsible person shall report the event to the interested bodies, by way of subordination — to authorised body and National Regulatory Body as prescribed by the legislation of the Republic of Armenia, in accordance with Form of Annex No 2 to this Decision, as well as shall provide inquiries, clarifications and any information related to the Rules.
6. When evaluating an event as “posing danger to public health”, based on Annexes No 3 and No 4 to the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010, the responsible person shall immediately report about it to the National Regulatory Body.
7. The body having identified the event shall also report to the National Coordinating Body the information with regard to all the response measures taken.
8. Where the event is unexpected or unusual and may bring about an “emergency situation in the sector of public health”, regardless of its origin or source, the National Regulatory Body shall be provided with the complete information by the body having identified the event, according to the Form of Annex No 2 to the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010.
9. In case of difficulties in assessing the event or lack of sufficient information to make a decision, the body recording the event may, in addition to the bodies regulating the given field, apply to a National Regulatory Body for assistance in assessing the information, or, if there is an interdepartmental issue, may convene a session of the Standing Interdepartmental Commission on the Application of International Healthcare (Medical and Sanitary) Rules, in order to identify the event.
10. The body having discovered the event may consult with the National Regulatory Body on the measures to be taken.
11. Each body shall, in response to the request submitted by World Health Organisation from other sources about an event allegedly having taken place in the territory of the Republic of Armenia, provide a preliminary response to the National Regulating Body, where relevant to its field, by confirming or denying the submitted information.
12. In response to an official inquiry from other sources by the National Regulatory Body about an event allegedly occurring in the territory of the Republic of Armenia, the relevant body shall, within 12 hours, provide to the National Regulatory Body with all the information at its disposal.
13. Confidential information shall be provided to the National Regulatory Body as prescribed by the legislation of the Republic of Armenia.
14. Each body shall evaluate the existing resources for event detection, evaluation and response capabilities and the process of developing, strengthening and maintaining those capabilities according to the recommendation of the National Regulatory Body, and shall provide the National Regulatory Body with written information containing the results of the evaluation.
15. Each body may apply to the National Regulatory Body for necessary consultation on developing, strengthening and maintaining event detection, evaluation and response capabilities.
16. Each body shall submit annual information to the National Regulatory Body by 1 February of each year, on its implemented and planned policies, strategies and programmes related to biological, chemical and radiation factors, hazards, as well as semi-annual information on the issues of compliance with the requirements of the Rules and introduction of the Rules into its system.
17. In cases where it is necessary to apply measures that impede international traffic and the application of which is not provided for by the Rules or temporary or permanent recommendations of World Health Organisation, the measures to be applied shall be agreed in advance with the National Regulatory Body.
18. The Ministry of Emergency Situations of the Republic of Armenia, acting as the authorised body for emergency situations, in the event of a public health emergency caused by biological, chemical and radiation factors, shall immediately provide all information at its disposal to the National Regulatory Body and cooperate in organising appropriate response measures.
19. Each body may submit a recommendation to the National Regulatory Body regarding Rules on issues related to its field for consideration by the Standing Interdepartmental Commission on the Application of International Healthcare (Medical and Sanitary) Rules with a view to submitting a corresponding proposal for consideration by the Health Assembly.
20. Each body shall, in accordance with the list of measures approved by the Protocol Decision of the Government of the Republic of Armenia “On Approval of the Strategy for the Introduction of International Healthcare (Medical and Sanitary) Rules and the Programme of Measures for the Introduction of International Healthcare (Medical and Sanitary) Rules” No 44 of 22 October 2009, within the prescribed time limits, inform the National Regulatory Body about the implementation of only a separate measure implemented by the given body.
In case of impossibility of implementing the measures within the schedule or time limits specified by the Rules, the body shall submit a written justification to the National Regulatory Body.
21. Each body shall, upon the request of the National Regulatory Body, submit detailed information on the presence of risk factors for public health in its field.
22. Each authorised body regulating the fields related to chemical, biological and radiation factors may nominate candidates for experts for the purpose of their inclusion in the national expert group for assistance to foreign States according to the Decision of the Government of the Republic of Armenia “On approval of the procedure for the formation of a National Expert Group for assistance to foreign States” No 1446-N of 10 December 2009.
23. Each body shall participate in the trainings organised by the National Regulatory Body in order to test the effectiveness of coordination mechanisms in the event of actual biological, chemical and radiation threats.
24. Each body shall, upon the request of the National Regulatory Body and in coordination with the Ministry of Emergency Situations of the Republic of Armenia, develop, approve, in a prescribed manner, and implement an action plan for responding to emergency situations in the field of public health in accordance with the established procedure.
25. In order to ensure the compliance with the requirements set forth by the Rules and implement the measures for the introduction of the Rules, each body shall, jointly with the National Regulatory Body, review the legislation regulating its sector.
III. PROCEDURES FOR COORDINATION OF THE MEASURES FOR COMPLIANCE WITH THE REQUIREMENTS OF THE RULES OF INTERESTED BODIES BY THE NATIONAL REGUATORY BODY FOR INTERNATIONAL HEALTHCARE (MEDICAL AND SANITARY) RULES
26. The National Regulatory Body shall regulate:
(1) the process of drawing up the list of responsible persons of interested bodies and gathering their contact details;
(2) when reporting an event, the process of providing consultation to interested bodies on the development of a procedure of reporting to the responsible person, giving consent to the procedure for reporting to the responsible person on the event, as well as shall gather the duplicate copies of the document approved by separate bodies, agreed with the National Regulatory Body;
(3) the activities aimed at the evaluation of information on the event, received from interested bodies. In the cases where the body having recorded the event is not the authorised body in the given field, the National Regulatory Body shall contact the body authorised in the given field in order to provide complete, detailed information related to the event;
(4) the process of evaluating information on unexpected or unusual events provided by the bodies having identified the event;
(5) where the body having the recorded the event has failed to inform the National Regulatory Body, in a prescribed manner, the National Regulatory Body shall, while getting informed of the event from other sources, make an official inquiry to the body having recorded the event. When learning about the event from non-official sources, the National Regulatory Body shall offer relevant body to clarify and specify the information received;
(6) the reporting activities in case the National Regulatory Body qualifies the event as a “public health emergency of international significance”, and shall inform through feedback to the body having recorded the event and, within 24 hours, shall report to World Health Organisation in accordance with the procedure established by the Decision of the Government of the Republic of Armenia “On approving the procedure for ensuring regular communication between the points of communication of the National Coordinating Body and World Health Organisation” No 913-N of 6 August 2009. In case of disagreements between the National Regulatory Body and the body having recorded the event, related to identification of the event, the issue shall be submitted for consideration by the existing Standing Interdepartmental Commission for Application of International Healthcare (Medical and Sanitary) Rules. The Commission shall consider the event and shall deliver its position on reporting the event to World Health Organisation;
(7) the process of evaluating information by each body on the organisation, implementation, results and effectiveness of public health measures taken in relation to the event according to the Rules;
(8) the process of providing consultation regarding the measures to be taken to respond to the event to the body having recorded the event (in cooperation with the State Committee for Nuclear Safety Regulation Adjunct to the Government of the Republic of Armenia during events caused by radiation factors);
(9) shall organise the provision of support to the response process undertaken by the body having identified the event;
(10) in order to respond to a request or clarification of information submitted by the World Health Organisation from other sources about an event allegedly having occurred in the territory of the Republic of Armenia, the information submitted for each field shall be reported to each body. World Health Organisation shall summarise and provide with a preliminary response containing confirmation or denial of the information submitted by them;
(11) the process of evaluating the available resources for capacities of incident detection, evaluation and provision of response in the Republic, as well as the process of developing, strengthening and maintaining these capacities. It shall summarise, analyse and evaluate the information obtained as a result of evaluation of this process by separate bodies;
(12) the process of providing each body with the necessary consultation for the development, strengthening and maintenance of capacities for event detection, evaluation and provision of response (in cooperation with the State Committee for Nuclear Safety Regulation Adjunct to the Government of the Republic of Armenia during events caused by radiation factors);
(13) shall coordinate the national system of epidemiological control of infectious diseases, which is based on separate systems of epidemiological control of infectious diseases, implemented by interested bodies;
(14) the process of gathering and summarising annual information on policies, strategies and programmes related to biological, chemical and radiological agents and hazards implemented by separate bodies within the framework of the Rules;
(15) shall consider measures applied in relation to an event submitted for coordination by relevant body that significantly impede international traffic and are not prescribed by temporary or permanent recommendations of World Health Organisation, and shall give consent or shall recommend not to apply the given measure;
(16) shall consider recommendations, aimed at submission for consideration by the Health Assembly, made by separate bodies on the Rules in respect of the issues related to its field, and the process of submitting them to the Standing Interdepartmental Commission for Application of International Healthcare (Medical and Sanitary) Rules for consideration;
(17) the process of implementing programme measures for the activities aimed at introduction of the Rules. It shall consider the written justification of the body on the impossibility of implementing the measures approved by the Protocol Decision of the Government of the Republic of Armenia “On approval of the strategy for the implementation of the International Healthcare (Medical and Sanitary) Rules and the Programme of Measures for the Introduction of International Healthcare (Medical and Sanitary) Rules” No 44 of 22 October 2009 in accordance with the implementation schedule or within the time limits specified by the Rules, and in case of a substantiated reasoning, the issue shall be submitted for consideration by the Standing Interdepartmental Commission for Implementation of International Healthcare (Medical and Sanitary) Rules. The Commission shall consider the issue and deliver its position. An amendment shall be made, in a prescribed manner, in the legal act in, or the country shall apply to World Health Organisation with a request to extend the established period for capacity building;
(18) communication of information to the interested bodies about the decision adopted by World Health Organisation on the end of “public health emergency of international significance”;
(19) shall receive information from the interested body on evaluation of the risk to public health in the given sector and shall compare it with the information received from other bodies due to the same factor or shall request the necessary information from relevant body;
(20) shall perform multi-factor analysis based on the information on events, received from interested bodies. For the purpose of ensuring the completeness of analysis, it may delegate relevant research to various state, public, scientific organisations, etc.;
(21) according to the Decision of the Government of the Republic of Armenia No 1446-N of 10 December 2009, the process of nominating candidates for experts by authorised bodies coordinating the fields related to chemical, biological and radiation agents aimed at involving in the national expert group in order to assist foreign States;
(22) shall coordinate the development of standard procedures for activities and the enforcement thereof;
(23) it may organise trainings involving specialists from interested departments in order to verify coordination mechanisms in the event of actual biological, chemical and radiation threats;
(24) activities for receiving semi-annual information regarding the issues for the implementation of the requirements and introduction of the Rules issued by the bodies;
(25) any information received from the points of communication of World Health Organisation, including information on public health risks and an event that may constitute a “public health emergency of international significance”, as well as recommendations (permanent and temporary) and any information related to the Rules shall be communicated to relevant interested bodies for the country to implement measures in accordance with the Rules;
(26) the National Regulatory Body may review coordination mechanisms in the event of actual biological, chemical and radiation risks or as a result of trainings;
(27) shall coordinate the development and implementation of an emergency response action plan in the sector of public health by interested bodies, with the participation of relevant representatives of the Ministry of Emergency Situations of the Republic of Armenia;
(28) shall coordinate the activities on making amendments and supplements to the legislation of the Republic of Armenia in order to increase the effectiveness of the measures for the implementation of the requirements of the Rules and introduction of the Rules, as well as on the discussion of recommendations submitted by interested bodies on the review and elaboration of the strategy for the introduction of the Rules and the measures arising therefrom.
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Chief of Staff of the Government of the Republic of Armenia |
D. Sargsyan |
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Annex No 2 to the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010 |
Form
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(name of the body related to the biological, chemical and radiation factor)
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REPORTING
ON PUBLIC HEALTH EMERGENCIES CAUSED BY BIOLOGICAL, CHEMICAL AND RADIATION FACTORS
(shall be sent to the National Regulatory Body, not later than within 24 hours from the moment of detecting the event under the conditions the data were priorly communicated by phone) | ||||||||||||||||||||||||||
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1. Type of the event — biological, chemical, radiation (underline)
2. Place for recording the event ___________________________________ __________________________region__________________________________
3. Head of the organisation considered as the place for recording the event ________________________ (surname, name, patronymic, phone number) __________________________________________________________________
4. Date of the event (1) emergence _______________________________________________ (2) detection _________________________________________________ (3) identification ______________________________________________
5. The event has the potential to cause significant consequences for public health
(1) the event was caused by a pathogen, which had high potential to cause an epidemic (factor contagiousness, high mortality, multiple pathways of infection or healthy carrier); (2) ineffectiveness of treatment (new or developing resistance to antibiotics, failure of vaccination, antidote ineffectiveness or resistance to the latter); (3) the event poses a significant risk to public health even where events where humans were infected were not recorded or small number of events have been recorded; (4) a number of events among medical workers; (5) population at risk is especially vulnerable (refugees, people having low level of vaccinations, children, elderly, people with low immune system, undernourished ones, etc.); (6) accompanying factors (natural disasters, armed conflicts, unfavourable weather conditions, multiple outbreaks across the country), which may postpone the response measures in the sector of public healthcare; (7) the event occurred in a densely populated region; (8) the spread of toxic, infectious and other dangerous substances, which may spread naturally or otherwise, which have infected or polluted or have the potential to spread infection or contamination among population and (or) in big geographic areas.
6. Is external help necessary, in order to reveal, study the current phenomenon, to respond to it, to control and manage it or to prevent new events from happening:
(1) insufficient human, financial, material or technical resources, in particular: a. insufficient laboratory or epidemiological capabilities for the examination of the event (equipment, personnel, financial resources), b. insufficient number of antidotes, medicines and (or) vaccines and (or) protective equipment, outwear, disinfection equipment or supportive means required for meeting the evaluated needs, c. the current epidemiological control system is not sufficient for timely detection of new events.
10. Is there a factor that may alert about the possible cross-border movement of the biological impulse, carrier or host? (1) the event is recorded in the given area for the first time in the current period, such event was never recorded, the event is related to recent events (event); (2) the event is related to international trips (or in case the pathogen is known, it complies with the secret period); (3) the event is related to the participation in international mass events (pilgrimage, sports event, symposium, etc.); (4) close communication with the international traveller or highly mobile population.
11. Has the event occurred as a result of contamination of the environment that has the potential to spread across international borders? (1) explosion; (2) leakage of chemical substance; (3) accident in the radiation source; (4) unknown source.
12. Is the event in an area of international traffic that has limited sanitary control capabilities for environmental detection or decontamination?
13. Has a similar event in the past caused restrictions on international trade and (or) traffic?
17. Have they contacted international organisations or international media outlets for additional information about the event?
18. Implemented primary anti-epidemic measures and additional information: _________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ _________________________________________________________________ |
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Chief of Staff of the Government of the Republic of Armenia |
D. Sargsyan |
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Annex No 3 to the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010 |
SCHEME
FOR REPORTING AND EVALUATING EVENTS CONSTITUTING A PUBLIC HEALTH EMERGENCY OF INTERNATIONAL SIGNIFICANCE
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Chief of Staff of the Government of the Republic of Armenia |
D. Sargsyan |
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Annex No 4 To the Decision of the Government of the Republic of Armenia No 1138-N of 26 August 2010 |
EXAMPLES OF SCHEMES
FOR THE ADOPTION OF A DECISION APPLICABLE TO THE EVALUATION AND REPORTING OF EVENTS THAT HAVE THE POTENTIAL TO CONSTITUTE PUBLIC HEALTH EMERGENCY OF INTERNATIONAL SIGNIFICANCE
1. The examples presented in this Annex shall not be mandatory and shall intend to assist in interpreting the criteria of the decision-making scheme for management purposes.
2. In the case where two of the 4 standard questions (I, II, III, IV) receive the answer “YES”, the event shall be subject to reporting to World Health Organisation, and therefore, immediate reporting to the National Regulatory Body for International Healthcare (Health and Sanitary) Rules.
DOES THE EVENT MEET BOTH OF THE CRITERIA PRESENTED BELOW?
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Does the event bear serious consequences for public healthcare? |
I. Does the event bear serious consequences for public healthcare?
Answer “Yes”, if You would answer “Yes” to questions 1, 2, 3. | ||
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1. Is the number of events or deaths for this type of event (phenomenon) greater than expected for the given area, period and population? | |||
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2. Does the event have the potential to cause significant consequences for public healthcare? (1) SIGNIFICANT IMPACT ON PUBLIC HEALTHCARE Was the event caused by a pathogen with high potential to cause an epidemic (contagiousness of the pathogen, high mortality, multiple routes of transmission or healthy carriers)? a. ineffectiveness of treatment (new or developing resistance to antibiotics, failure of vaccination, ineffectiveness of antidote or resistance to it); b. the event poses a significant risk to public healthcare, even where yet no event was recorded among people or small number of events were recorded; c. events were recorded among medical workers; d. vulnerable risk groups (refugees, low level of vaccinations, children, elderly, people with low immune system, undernourished ones, etc.); e. accompanying factors (natural disasters, armed conflicts, unfavourable weather conditions, multiple outbreaks in the area), which may postpone the response measures in the sector of public healthcare; f. the event occurred in a densely populated region; g. the spread of toxic, infectious and other dangerous substances, which may spread naturally or otherwise, which have infected or have the potential to infect the population and (or) big geographic areas. | |||
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3. Is external assistance necessary to identify, investigate, respond to, control and manage the current phenomenon or prevent new events from occurring? (1) HELP MAY BE NEEDED IN CASE OF BELOW MENTIONED EVENTS insufficient human, financial, material or technical resources, in particular: a. insufficient laboratory or epidemiological capabilities for the examination of the event (equipment, personnel, means of transportation, financial resources); insufficient number of antidotes, medicines and (or) vaccines and (or) protective equipment, disinfection equipment or supportive means required to meet the evaluated needs; b. the current epidemiological control system is not sufficient for timely detection of new events (where a disease is new and still scientifically unknown, etc.). | |||
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Is the event unusual or unexpected? |
II. Is the event unusual or unexpected?
Answer “Yes”, if You would answer “Yes” to questions 4, 5. | ||
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4. Is the event unusual? (1) THE BELOW MENTIONED ONES ARE EXAMPLES OF UNUSUAL EVENTS a. the event was caused by an unknown trigger, or the source, transmitter, route of transmission is unusual or unknown, b. the course of events is more severe than expected (including morbidity or mortality), or events have unusual symptoms, c. the origin of the event is itself unusual for the area, weather or for the population. | |||
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5. Is the event unexpected from the point of public healthcare? (1) the event was caused by a disease (trigger) that had already been eliminated, had been eradicated in the territory of the State or had not been previously reported. | |||
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Is there a significant risk to spread internationally? |
III. Is there a significant risk to spread internationally?
Answer “Yes”, if You would answer “Yes” to questions 6, 7. | ||
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6. Are there reliable data or epidemiological relation to similar events in other States? | |||
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7. Is there a factor that may alert about the trigger, carrier or the possible cross-border movement of the host?: (1) Is there evidence about the spread (indicator (index), event or events that occurred during last month) related to: | |||
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a. international trips (or in case the pathogen is known,equivalent to the secret period); b. participation in an international mass event (pilgrimage, sports event, symposium, etc.); c. close communication with the international traveller or mobile population; d. the event was caused by environmental pollution with the potential to spread internationally; e. the event took place in the territory of international heavy traffic, which has limited capabilities of sanitary control for detection and neutralisation in the environment. | |||
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There is a risk of international limitations. |
IV. Is there a significant risk to international traffic or trade?
Answer “Yes”, if You would answer “Yes” to questions 8-11. | ||
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8. Have similar events in the past caused international trade and (or) traffic limitations? | |||
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9. Is the factor of transmission of the suspected or known infection some food, water or other goods, which may have been contaminated and which is imported from other States or is exported to other States. | |||
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10. Did the event occur in connection with international gatherings or in places of active international tourism. | |||
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11. Have foreign officials or international media outlets requested additional information about the event? |
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Chief of Staff of the Government of the Republic of Armenia |
D. Sargsyan |
Published on a joint site 09.07.2025.