WHA77.17

1. F or the purposes of the International Health Regulations (hereinafter “the IHR” or “Regulations”): “affected” means persons, baggage, cargo, containers, conveyances, goods, postal parcels or human remains that are infected or contaminated, or carry sources of infection or contamination, so as to constitute a public health risk; “affected area” means a geographical location specifically for which health measures have been recommended by WHO under these Regulations; “aircraft” means an aircraft making an international voyage; “airport” means any airport where international flights arrive or depart; “arrival” of a conveyance means: (a) in the case of a seagoing vessel, arrival or anchoring in the defined area of a port; (b) in the case of an aircraft, arrival at an airport; (c) in the case of an inland navigation vessel on an international voyage, arrival at a point of entry; (d) in the case of a train or road vehicle, arrival at a point of entry; (e) “baggage” means the personal effects of a traveller; “cargo” means goods carried on a conveyance or in a container; “competent authority” means an authority responsible for the implementation and application of health measures under these Regulations; “container” means an article of transport equipment: (a) of a permanent character and accordingly strong enough to be suitable for repeated use; (b) specially designed to facilitate the carriage of goods by one or more modes of transport, without intermediate reloading; (c) fitted with devices permitting its ready handling, particularly its transfer from one mode of transport to another; and (d) specially designed as to be easy to fill and empty; “container loading area” means a place or facility set aside for containers used in international traffic; “contamination” means the presence of an infectious or toxic agent or matter on a human or animal body surface, in or on a product prepared for consumption or on other inanimate objects, including conveyances, that may constitute a public health risk; “conveyance” means an aircraft, ship, train, road vehicle or other means of transport on an international voyage; “conveyance operator” means a natural or legal person in charge of a conveyance or their agent; “crew” means persons on board a conveyance who are not passengers; “decontamination” means a procedure whereby health measures are taken to eliminate an infectious or toxic agent or matter on a human or animal body surface, in or on a product prepared for consumption or on other inanimate objects, including conveyances, that may constitute a public health risk; “departure” means, for persons, baggage, cargo, conveyances or goods, the act of leaving a territory; “deratting” means the procedure whereby health measures are taken to control or kill rodent vectors of human disease present in baggage, cargo, containers, conveyances, facilities, goods and postal parcels at the point of entry; “Director-General” means the Director-General of the World Health Organization; “disease” means an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans; “disinfection” means the procedure whereby health measures are taken to control or kill infectious agents on a human or animal body surface or in or on baggage, cargo, containers, conveyances, goods and postal parcels by direct exposure to chemical or physical agents; “disinsection” means the procedure whereby health measures are taken to control or kill the insect vectors of human diseases present in baggage, cargo, containers, conveyances, goods and postal parcels; “event” means a manifestation of disease or an occurrence that creates a potential for disease; “free pratique” means permission for a ship to enter a port, embark or disembark, discharge or load cargo or stores; permission for an aircraft, after landing, to embark or disembark, discharge or load cargo or stores; and permission for a ground transport vehicle, upon arrival, to embark or disembark, discharge or load cargo or stores; “goods” mean tangible products, including animals and plants, transported on an international voyage, including for utilization on board a conveyance; “ground crossing” means a point of land entry in a State Party, including one utilized by road vehicles and trains; “ground transport vehicle” means a motorized conveyance for overland transport on an international voyage, including trains, coaches, lorries and automobiles; “health measure” means procedures applied to prevent the spread of disease or contamination; a health measure does not include law enforcement or security measures; “ill person” means an individual suffering from or affected with a physical ailment that may pose a public health risk; “infection” means the entry and development or multiplication of an infectious agent in the body of humans and animals that may constitute a public health risk; “inspection” means the examination, by the competent authority or under its supervision, of areas, baggage, containers, conveyances, facilities, goods or postal parcels, including relevant data and documentation, to determine if a public health risk exists; “international traffic” means the movement of persons, baggage, cargo, containers, conveyances, goods or postal parcels across an international border, including international trade; “international voyage” means: (a) in the case of a conveyance, a voyage between points of entry in the territories of more than one State, or a voyage between points of entry in the territory or territories of the same State if the conveyance has contacts with the territory of any other State on its voyage but only as regards those contacts; (b) in the case of a traveller, a voyage involving entry into the territory of a State other than the territory of the State in which that traveller commences the voyage; “intrusive” means possibly provoking discomfort through close or intimate contact or questioning; “invasive” means the puncture or incision of the skin or insertion of an instrument or foreign material into the body or the examination of a body cavity. For the purposes of these Regulations, medical examination of the ear, nose and mouth, temperature assessment using an ear, oral or cutaneous thermometer, or thermal imaging; medical inspection; auscultation; external palpation; retinoscopy; external collection of urine, faeces or saliva samples; external measurement of blood pressure; and electrocardiography shall be considered to be non-invasive; “isolation” means separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels from others in such a manner as to prevent the spread of infection or contamination; “medical examination” means the preliminary assessment of a person by an authorized health worker or by a person under the direct supervision of the competent authority, to determine the person's health status and potential public health risk to others, and may include the scrutiny of health documents, and a physical examination when justified by the circumstances of the individual case; “National IHR Authority” means the entity designated or established by the State Party at the national level to coordinate the implementation of these Regulations within the jurisdiction of the State Party; “National IHR Focal Point” means the national centre, designated by each State Party, which shall be accessible at all times for communications with WHO IHR Contact Points under these Regulations; “Organization” or “WHO” means the World Health Organization; “pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and: (i) has, or is at high risk of having, wide geographical spread to and within multiple States; and (ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and (iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and (iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-o f-society approaches. “permanent residence” has the meaning as determined in the national law of the State Party concerned; “personal data” means any information relating to an identified or identifiable natural person; “point of entry” means a passage for international entry or exit of travellers, baggage, cargo, containers, conveyances, goods and postal parcels as well as agencies and areas providing services to them on entry or exit; “port” means a seaport or a port on an inland body of water where ships on an international voyage arrive or depart; “postal parcel” means an addressed article or package carried internationally by postal or courier services; “public health emergency of international concern” means an extraordinary event which is determined, as provided in these Regulations: (i) to constitute a public health risk to other States through the international spread of disease ; and (ii) to potentially require a coordinated international response; “public health observation” means the monitoring of the health status of a traveller over time for the purpose of determining the risk of disease transmission; “public health risk” means a likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger; “quarantine” means the restriction of activities and/or separation from others of suspect persons who are not ill or of suspect baggage, containers, conveyances or goods in such a manner as to prevent the possible spread of infection or contamination; “recommendation” and “recommended” refer to temporary or standing recommendations issued under these Regulations; “relevant health products” means those health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies; “reservoir” means an animal, plant or substance in which an infectious agent normally lives and whose presence may constitute a public health risk; “road vehicle” means a ground transport vehicle other than a train; “scientific evidence” means information furnishing a level of proof based on the established and accepted methods of science; “scientific principles” means the accepted fundamental laws and facts of nature known through the methods of science; “ship” means a seagoing or inland navigation vessel on an international voyage; “standing recommendation” means non-binding advice issued by WHO for specific ongoing public health risks pursuant to Article 16 regarding appropriate health measures for routine or periodic application needed to prevent or reduce the international spread of disease and minimize interference with international traffic; “surveillance” means the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary; “suspect” means those persons, baggage, cargo, containers, conveyances, goods or postal parcels considered by a State Party as having been exposed, or possibly exposed, to a public health risk and that could be a possible source of spread of disease; “temporary recommendation” means non-binding advice issued by WHO pursuant to Article 15 for application on a time-limited, risk-specific basis, in response to a public health emergency of international concern, so as to prevent or reduce the international spread of disease and minimize interference with international traffic; “temporary residence” has the meaning as determined in the national law of the State Party concerned; “traveller” means a natural person undertaking an international voyage; “vector” means an insect or other animal which normally transports an infectious agent that constitutes a public health risk; “verification” means the provision of information by a State Party to WHO confirming the status of an event within the territory or territories of that State Party; “WHO IHR Contact Point” means the unit within WHO which shall be accessible at all times for communications with the National IHR Focal Point. 2. U nless otherwise specified or determined by the context, reference to these Regulations includes the ANNEXes thereto. Article 2 Purpose and scope The purpose and scope of these Regulations are to prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risk and which avoid unnecessary interference with international traffic and trade. Article 3 Principles 1. The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons , and shall promote equity and solidarity. 2. The implementation of these Regulations shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization. 3. The implementation of these Regulations shall be guided by the goal of their universal application for the protection of all people of the world from the international spread of disease. 4. S tates have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to legislate and to implement legislation in pursuance of their health policies. In doing so , they should uphold the purpose of these Regulations. Article 4 Responsible authorities 1. E ach State Party shall designate or establish , in accordance with its national law and context, one or two entities to serve as National IHR Authority and a National IHR Focal Point , and as well as the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations. 1 bis. The National IHR Authority shall coordinate the implementation of these Regulations within the jurisdiction of the State Party. 2. N ational IHR Focal Points shall be accessible at all times for communications with the WHO IHR Contact Points provided for in paragraph 3 of this Article. The functions of National IHR Focal Points shall include: (a) sending to WHO IHR Contact Points, on behalf of the State Party concerned, urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12; and (b) disseminating information to, and consolidating input from, relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments.] 2 bis. States Parties shall take measures to implement paragraphs 1, 1 bis , and 2 of this Article, including, as appropriate, adjusting their domestic legislative and/or administrative arrangements. 3. WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points. WHO IHR Contact Points shall send urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12, to the National IHR Focal Point of the States Parties concerned. WHO IHR Contact Points may be designated by WHO at the headquarters or at the regional level of the Organization. 4. S tates Parties shall provide WHO with contact details of their National IHR Authority and their National IHR Focal Point and WHO shall provide States Parties with contact details of WHO IHR Contact Points. These contact details shall be continuously updated and annually confirmed. WHO shall make the contact details available to all States Parties. PART II – INFORMATION AND PUBLIC HEALTH RESPONSE Article 5 Surveillance 1. E ach State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacit y ies to prevent, detect, assess, notify and report events in accordance with these Regulations, as specified in

1. 2. F ollowing the assessment referred to in paragraph 2 Part A of ANNEX 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances , and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Committee established under Article 50 (hereinafter the “Review Committee”). After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation. 3. WHO shall assist States Parties, upon request, to develop, strengthen and maintain the core capacities referred to in paragraph 1 of this Article. 4. WHO shall collect information regarding events through its surveillance activities and assess their potential to cause international disease spread and possible interference with international traffic. Information received by WHO under this paragraph shall be handled in accordance with Articles 11 and 45 where appropriate. Article 6 Notification 1. E ach State Party shall assess events occurring within its territory by using the decision instrument in ANNEX 2. E ach State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by WHO involves the competency of the International Atomic Energy Agency (IAEA) or other intergovernmental organization(s), WHO shall , pursuant to paragraph 1 of Article 14, immediately notify the IAEA or, as appropriate, the other competent intergovernmental organization(s). 2. F ollowing a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern. Article 7 Information-sharing during unexpected or unusual public health events If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full. Article 8 Consultation In the case of events occurring within its territory not requiring notification as provided in Article 6, in particular those events for which there is insufficient information available to complete the decision instrument, a State Party should nevertheless keep WHO advised thereof through the National IHR Focal Point and consult with WHO on appropriate health measures in a timely manner. Such communications shall be treated in accordance with paragraphs 2 to 4 of Article 11. The State Party in whose territory the event has occurred may request WHO assistance to assess any epidemiological evidence obtained by that State Party. Article 9 Other reports 1. WHO may take into account reports from sources other than notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the State Party in whose territory the event is allegedly occurring. Before taking any action based on such reports, WHO shall consult with and attempt to obtain verification from the State Party in whose territory the event is allegedly occurring in accordance with the procedure set forth in Article 10. To this end, WHO shall make the information received available to the States Parties and only where it is duly justified may WHO maintain the confidentiality of the source. This information will be used in accordance with the procedure set forth in Article 11. 2. S tates Parties shall, as far as practicable, inform WHO within 24 hours of receipt of evidence of a public health risk identified outside their territory that may cause international disease spread, as manifested by exported or imported: (a) human cases; (b) vectors which carry infection or contamination; or (c) goods that are contaminated. Article 10 Verification 1. WHO shall request, in accordance with Article 9, verification from a State Party of reports from sources other than notifications or consultations of events which may constitute a public health emergency of international concern allegedly occurring in the State's territory. In such cases, WHO shall inform the State Party concerned regarding the reports it is seeking to verify. 2. P ursuant to the foregoing paragraph and to Article 9, each State Party, when requested by WHO, shall verify and provide: (a) within 24 hours, an initial reply to, or acknowledgement of, the request from WHO; (b) within 24 hours, available public health information on the status of events referred to in WHO's request; and (c) information to WHO in the context of an assessment under Article 6, including relevant information as described in that Article. 3. W hen WHO receives Upon receiving information of an event that may constitute a public health emergency of international concern, it WHO shall offer to collaborate with the State Party concerned in assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures. Such activities may include collaboration with other standard‑setting organizations and the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer. 4. If the State Party does not accept the offer of collaboration, and when justified by the magnitude of the public health risk, WHO should share with other States Parties the information about the event available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO, taking into account the views of the State Party concerned. Article 11 Provision of information by WHO 1. S ubject to paragraph 2 of this Article, WHO shall send to all States Parties and, as appropriate, to relevant intergovernmental organizations, as soon as possible and by the most efficient means available, in confidence, such public health information which it has received under Articles 5 to 10 inclusive and which is necessary to enable States Parties to respond to a public health risk. WHO should communicate information to other States Parties that might help them in preventing the occurrence of similar incidents. 2. WHO shall use information received under Articles 6 and 8 and paragraph 2 of Article 9 for verification, assessment and assistance purposes under these Regulations and, unless otherwise agreed with the States Parties referred to in those provisions, shall not make this information generally available to other States Parties, until such time as: (a) the event is determined to constitute a public health emergency of international concern , including a pandemic emergency, in accordance with Article 12; or (b) information evidencing the international spread of the infection or contamination has been confirmed by WHO in accordance with established epidemiological principles; or (c) there is evidence that: (i) control measures against the international spread are unlikely to succeed because of the nature of the contamination, disease agent, vector or reservoir; or (ii) the State Party lacks sufficient operational capacity to carry out necessary measures to prevent further spread of disease; or (d) the nature and scope of the international movement of travellers, baggage, cargo, containers, conveyances, goods or postal parcels that may be affected by the infection or contamination requires the immediate application of international control measures. 3. WHO shall consult with the State Party in whose territory the event is occurring as to its intent to make information available under this Article. 4. W hen information received by WHO under paragraph 2 of this Article is made available to States Parties in accordance with these Regulations, WHO may also make it available to the public if other information about the same event has already become publicly available and there is a need for the dissemination of authoritative and independent information. Article 12 Determination of a public health emergency of international concern , including a pandemic emergency 1. The Director-General shall determine, on the basis of the information received, in particular from the State (s) Party (ies) within whose territory (ies) an event is occurring, whether an event constitutes a public health emergency of international concern , including, when appropriate, a pandemic emergency, in accordance with the criteria and the procedure set out in these Regulations. 2. If the Director-General considers, based on an assessment under these Regulations, that a public health emergency of international concern is occurring, the Director-General shall consult with the State (s) Party (ies) in whose territory (ies) the event is occurring arises regarding this preliminary determination. If the Director-General and the State (s) Party (ies) are in agreement regarding this determination, the Director-General shall, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”) on appropriate temporary recommendations. 3. If, following the consultation in paragraph 2 above, the Director-General and the State (s) Party (ies) in whose territory (ies) the event is occurring arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination shall be made in accordance with the procedure set forth in Article 49. 4. In determining whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency, the Director-General shall consider: (a) information provided by the State (s) Party (ies); (b) the decision instrument contained in

5. If the Director-General, having considered the matters contained in subparagraphs (a), (c), (d) and (e) of paragraph 4 of this Article, and following consultations with the State (s) Party (ies) within whose territory (ies) the a public health emergency of international concern , including a pandemic emergency, has occurred, considers that a public health emergency of international concern, including a pandemic emergency, has ended, because it no longer meets the relevant definition in Article 1, the Director-General shall take a decision in accordance with the procedure set out in Article 49. Article 13 Public health response , including equitable access to relevant health products 1. E ach State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacit y ies to prevent, prepare for, and respond promptly and effectively to public health risks and public health emergencies of international concern , including a pandemic emergency, including in fragile and humanitarian settings, as set out in ANNEX 1. WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response core capacities. 2. F ollowing the assessment referred to in paragraph 2 Part A of ANNEX 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Review Committee. After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation. 3. A t the request of a State Party or following its acceptance of an offer by WHO, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary. 4. If WHO, in consultation with the States Parties concerned as provided in Article 12, determines that a public health emergency of international concern , including a pandemic emergency, is occurring, it may offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State (s) Party (ies), including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer. 5. W hen requested by WHO, States Parties should provide, to the extent possible, support to WHO-coordinated response activities. 6. W hen requested, WHO shall provide appropriate guidance and assistance to other States Parties affected or threatened by the public health emergency of international concern , including a pandemic emergency. 7. WHO shall support States Parties, upon their request or following acceptance of an offer from WHO, and coordinate international response activities during public health emergencies of international concern, including pandemic emergencies, after their determination pursuant to Article 12 of these Regulations. 8. WHO shall facilitate, and work to remove barriers to, timely and equitable access by States Parties to relevant health products after the determination of and during a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs. To that effect, the Director-General shall: (a) conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating recommendations pursuant to Articles 15, 16, 17, 18, and 49 of these Regulations; (b) make use of WHO-coordinated mechanisms, or facilitate, in consultation with States Parties, their establishment as needed, and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs; (c) support States Parties, upon their request, in scaling up and geographically diversifying the production of relevant health products, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, subject to Article 2 of these Regulations, and in accordance with relevant international law; (d) share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party. ; and (e) support States Parties, upon their request, and, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, pursuant to subparagraph 8(c) of this Article, to promote research and development and strengthen local production of quality, safe and effective relevant health products, and facilitate other measures relevant for the full implementation of this provision. 9. P ursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through: (a) supporting WHO in implementing actions outlined in this Article; (b) engaging with and encouraging relevant stakeholders operating in their respective jurisdictions to facilitate equitable access to relevant health products for responding to a public health emergency of international concern, including a pandemic emergency; and (c) making available, as appropriate, relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency. Article 14 Cooperation of WHO with intergovernmental organizations and international bodies 1. WHO shall cooperate and coordinate its activities, as appropriate, with other competent intergovernmental organizations or international bodies in the implementation of these Regulations, including through the conclusion of agreements and other similar arrangements. 2. In cases in which notification or verification of, or response to, an event is primarily within the competence of other intergovernmental organizations or international bodies, WHO shall coordinate its activities with such organizations or bodies in order to ensure the application of adequate measures for the protection of public health. 3. N otwithstanding the foregoing, nothing in these Regulations shall preclude or limit the provision by WHO of advice, support, or technical or other assistance for public health purposes. PART III – RECOMMENDATIONS Article 15 Temporary recommendations 1. If it has been determined in accordance with Article 12 that a public health emergency of international concern , including a pandemic emergency, is occurring, the Director-General shall issue temporary recommendations in accordance with the procedure set out in Article 49. Such temporary recommendations may be modified or extended as appropriate, including after it has been determined that a public health emergency of international concern , including a pandemic emergency, has ended, at which time other temporary recommendations may be issued as necessary for the purpose of preventing or promptly detecting its recurrence. 2. T emporary recommendations may include health measures to be implemented by the State (s) Party (ies) experiencing the public health emergency of international concern, including a pandemic emergency, or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods , including relevant health products, and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic. 2 bis. The Director-General, when communicating to States Parties the issuance, modification or extension of temporary recommendations, should provide available information on any WHO‑coordinated mechanism(s) concerning access to, and allocation of, relevant health products, as well as on any other allocation and distribution mechanisms and networks. 3. T emporary recommendations may be terminated in accordance with the procedure set out in Article 49 at any time and shall automatically expire three months after their issuance. They may be modified or extended for additional periods of up to three months. Temporary recommendations may not continue beyond the second World Health Assembly after the determination of the public health emergency of international concern , including a pandemic emergency, to which they relate. Article 16 Standing recommendations 1. WHO may make standing recommendations of appropriate health measures in accordance with Article 53 for routine or periodic application. Such measures may be applied by States Parties regarding persons, baggage, cargo, containers, conveyances, goods including relevant health products, and/or postal parcels for specific, ongoing public health risks in order to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic. WHO may, in accordance with Article 53, modify or terminate such recommendations, as appropriate. 2. The Director-General, when communicating to States Parties the issuance, modification or extension of standing recommendations, should provide available information on any WHO-coordinated mechanism(s) concerning access to, and allocation of, relevant health products as well as on any other allocation and distribution mechanisms and networks. Article 17 Criteria for recommendations When issuing, modifying or terminating temporary or standing recommendations, the Director‑General shall consider: (a) the views of the States Parties directly concerned; (b) the advice of the Emergency Committee or the Review Committee, as the case may be; (c) scientific principles as well as available scientific evidence and information; (d) health measures that, on the basis of a risk assessment appropriate to the circumstances, are not more restrictive of international traffic and trade and are not more intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection; (d bis) availability of, and accessibility to relevant health products; (e) relevant international standards and instruments; (f) activities undertaken by other relevant intergovernmental organizations and international bodies; and (g) other appropriate and specific information relevant to the event. With respect to temporary recommendations, the consideration by the Director-General of subparagraphs (e) and (f) of this Article may be subject to limitations imposed by urgent circumstances. Article 18 Recommendations with respect to persons, baggage, cargo, containers, conveyances, goods and postal parcels 1. R ecommendations issued by WHO to States Parties with respect to persons may include the following advice: – no specific health measures are advised; – review travel history in affected areas; – review proof of medical examination and any laboratory analysis; – require medical examinations; – review proof of vaccination or other prophylaxis; – require vaccination or other prophylaxis; – place suspect persons under public health observation; – implement quarantine or other health measures for suspect persons; – implement isolation and treatment where necessary of affected persons; – implement tracing of contacts of suspect or affected persons; – refuse entry of suspect and affected persons; – refuse entry of unaffected persons to affected areas; – implement exit screening and/or restrictions on persons from affected areas. 2. R ecommendations issued by WHO to States Parties with respect to baggage, cargo, containers, conveyances, goods and postal parcels may include the following advice: – no specific health measures are advised; – review manifest and routing; – implement inspections; – review proof of measures taken on departure or in transit to eliminate infection or contamination; – implement treatment of the baggage, cargo, containers, conveyances, goods, postal parcels or human remains to remove infection or contamination, including vectors and reservoirs; – the use of specific health measures to ensure the safe handling and transport of human remains; – implement isolation or quarantine; – seizure and destruction of infected or contaminated or suspect baggage, cargo, containers, conveyances, goods or postal parcels under controlled conditions if no available treatment or process will otherwise be successful; – refuse departure or entry . 3. R ecommendations issued by WHO to State Parties shall, as appropriate, take into account the need to: (a) facilitate international travel, particularly of health and care workers and persons in life-threatening or humanitarian situations. This provision is without prejudice to Article 23 of these Regulations; and (b) maintain international supply c hains, including for relevant health products and food supplies. PART IV – POINTS OF ENTRY Article 19 General obligations Each State Party shall, in addition to the other obligations provided for under these Regulations: (a) ensure that the core capacities set forth in ANNEX 1 for designated points of entry are developed within the time frame provided in paragraph 1 of Article 5 and paragraph 1 of Article 13; (b) identify the competent authorities at each designated point of entry in its territory; and (c) furnish to WHO, as far as practicable, when requested in response to a specific potential public health risk, relevant data concerning sources of infection or contamination, including vectors and reservoirs, at its points of entry, which could result in international disease spread. Article 20 Airports and ports 1. S tates Parties shall designate the airports and ports that shall develop the core capacities provided in ANNEX 1. 2. S tates Parties shall ensure that Ship Sanitation Control Exemption Certificates and Ship Sanitation Control Certificates are issued in accordance with the requirements in Article 39 and the model provided in

1. C onveyance operators shall prepare for, as appropriate, and facilitate: (a) inspections of the cargo, containers and conveyance; (b) medical examinations of persons on board; (c) application of other health measures under these Regulations , including on board as well as during embar k ation and disembar k ation; and (d) provision of relevant public health information requested by the State Party. 2. C onveyance operators shall provide to the competent authority a valid Ship Sanitation Control Exemption Certificate or a Ship Sanitation Control Certificate or a Maritime Ship Declaration of Health, or the Health Part of an Aircraft General Declaration, as required under these Regulations. Section B Conveyances 1. C ontrol measures applied to baggage, cargo, containers, conveyances and goods under these Regulations shall be carried out so as to avoid as far as possible injury or discomfort to persons or damage to the baggage, cargo, containers, conveyances and goods. Whenever possible and appropriate, control measures shall be applied when the conveyance and holds are empty. 2. S tates Parties shall indicate in writing the measures applied to cargo, containers or conveyances, the parts treated, the methods employed, and the reasons for their application. This information shall be provided in writing to the person in charge of an aircraft and, in case of a ship, on the Ship Sanitation Control Certificate. For other cargo, containers or conveyances, States Parties shall issue such information in writing to consignors, consignees, carriers, the person in charge of the conveyance or their respective agents.

1. WHO shall publish, on a regular basis, a list of areas where disinsection or other vector control measures are recommended for conveyances arriving from these areas. Determination of such areas shall be made pursuant to the procedures regarding temporary or standing recommendations, as appropriate. 2. E very conveyance leaving a point of entry situated in an area where vector control is recommended should be disinsected and kept free of vectors. When there are methods and materials advised by the Organization for these procedures, these should be employed. The presence of vectors on board conveyances and the control measures used to eradicate them shall be included: (a) in the case of aircraft, in the Health Part of the Aircraft General Declaration, unless this part of the Declaration is waived by the competent authority at the airport of arrival; (b) in the case of ships, on the Ship Sanitation Control Certificates; and (c) in the case of other conveyances, on a written proof of treatment issued to the consignor, consignee, carrier, the person in charge of the conveyance or their agent, respectively. 3. S tates Parties should accept disinsecting, deratting and other control measures for conveyances applied by other States if methods and materials advised by the Organization have been applied. 4. S tates Parties shall establish programmes to control vectors that may transport an infectious agent that constitutes a public health risk to a minimum distance of 400 metres from those areas of point of entry facilities that are used for operations involving travellers, conveyances, containers, cargo and postal parcels, with extension of the minimum distance if vectors with a greater range are present. 5. If a follow-up inspection is required to determine the success of the vector control measures applied, the competent authorities for the next known port or airport of call with a capacity to make such an inspection shall be informed of this requirement in advance by the competent authority advising such follow-up. In the case of ships, this shall be noted on the Ship Sanitation Control Certificate. 6.A conveyance may be regarded as suspect and should be inspected for vectors and reservoirs if: (a) it has a possible case of vector-borne disease on board; (b) a possible case of vector-borne disease has occurred on board during an international voyage; or (c) it has left an affected area within a period of time where on-board vectors could still carry disease. 7.A State Party should not prohibit the landing of an aircraft or berthing of a ship in its territory if the control measures provided for in paragraph 3 of this ANNEX or otherwise recommended by the Organization are applied. However, aircraft or ships coming from an affected area may be required to land at airports or divert to another port specified by the State Party for that purpose. 8.A State Party may apply vector control measures to a conveyance arriving from an area affected by a vector-borne disease if the vectors for the foregoing disease are present in its territory.

3. REQUESTS the Director-General: (1) to give prompt notification of the amendments to the International Health Regulations (2005) adopted through this resolution, in accordance with paragraph 1 of Article 65 of the International Health Regulations (2005), on the understanding that, prior to such notification, the Director-General shall ensure the uniformity of the Arabic, Chinese, English, French, Russian and Spanish texts of the amendments, allowing for State Party review and input on language conformity and accuracy; (2) to inform other competent intergovernmental organizations or international bodies of the amendments to the International Health Regulations (2005) adopted through this resolution, including specifically the International Maritime Organization regarding amended Article 37 and ANNEXes 3, 4 and 8 to the International Health Regulations (2005); (3) to commence work, in advance of the entry into force of the amendments adopted through this resolution, on matters addressed in all amended Articles, and to prepare and publish a consolidated version of the amended International Health Regulations (2005); (4) to collaborate with States Parties, to the extent possible, in the mobilization of predictable, sustainable and timely financial resources to support developing countries in developing, strengthening and maintaining the capacities required under the amended International Health Regulations (2005); (5) to facilitate the process for the Eightieth World Health Assembly to review the functioning of the amended International Health Regulations (2005), in accordance with paragraph 2 of Article 54 of the amended International Health Regulations (2005); (6) to facilitate the convening of the first meeting of the States Parties Committee for the Implementation of the International Health Regulations (2005), in accordance with Article 54 bis of the amended International Health Regulations (2005), no later than one year after entry into force of the amended International Health Regulations (2005); (7) to develop, and regularly review in consultation with Member States, the risk assessment approach to inform the determination of public health emergencies of international concern, including pandemic emergencies. ANNEX 6 VACCINATION, PROPHYLAXIS AND RELATED CERTIFICATES 1. V accines or other prophylaxis specified in