Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation in respect of that State Party, the capacity to detect, evaluate, notify and declare Events pursuant to this Regulation, as shown in Annex 1.

2. As a result of the assessment under s. 2 of Part A of Annex 1, a State Party may report to the WHO on the grounds of a justified need and an action plan and, in so doing, obtain an additional period of two years to fulfil its obligation under s. 1 of this article. In exceptional circumstances and by submitting a new action plan, the State Party may request that the time limit be extended to the Director General for a further period of two years, taking into account the technical advice of the Committee established under s. 50 (hereinafter the "Review Panel"). After the period provided for in par. 1 of this Article, the State Party which has obtained an additional period shall report annually to the WHO on the progress made in the full implementation.

3. The WHO assists States Parties, at their request, in acquiring, strengthening and maintaining the capabilities referred to in s. 1 of this article.

4. WHO collects information on events as part of its surveillance activities, and assesses the risk of international spread of diseases and the barriers to international traffic that they can create. The information received by the WHO under this paragraph shall be treated in accordance with the provisions of Art. 11 and 45 where applicable.

Each State Party shall evaluate the events taking place in its territory by means of the instrument of decision presented in Annex 2. Each State Party shall notify the WHO, through the most effective means of communication available to it, by The intermediary of the national focal point RSI and within 24 hours of the evaluation of public health information, any event in its territory which may constitute an international public health emergency in the light of The decision instrument, as well as any health measures taken to deal with these events. If the notification received by the WHO affects the competence of the International Atomic Energy Agency (IAEA), the WHO will immediately inform the IAEA.

2. After notification, the State Party shall continue to communicate in due time to WHO the accurate and sufficiently detailed public health information available to it, if possible including case definition, laboratory results, The source and type of risk, the number of cases and deaths, the factors affecting the spread of the disease and the health measures used; and indicates, if necessary, the difficulties encountered and the assistance it needs to cope with The potential international public health emergency.

If a State Party has elements indicating the occurrence of an unexpected or unusual event on its territory, regardless of its origin or source, which may constitute an international public health emergency, it shall provide to WHO Any relevant public health information. In this case, the provisions of s. 6 apply in full.

In the event that events do not require the notification provided for in s. 6, in particular events for which it does not have sufficient information to use the decision-making instrument, a State Party may nevertheless keep the WHO informed through its national focal point RSI, and Consult WHO on the health measures to be taken. Such communications shall be governed by the provisions of s. 2 to 4 of the art. 11. The State Party on whose territory the event occurred may ask WHO to assist it in verifying the epidemiological information it has been able to obtain.

1. The WHO may take account of reports from sources other than notifications or consultations and evaluates these reports in accordance with established epidemiological principles; it then provides information on the event in question. The State Party on whose territory this event is supposed to occur. Before taking any action on the basis of these reports, WHO shall consult the State Party on whose territory the event is intended to occur and shall endeavour to verify such information with the State Party in accordance with the procedures of the Audit defined in s. 10. To this end, WHO shall make the information received available to the States Parties, knowing that, only in cases where this is duly justified, the WHO may preserve the confidential nature of the source. This information shall be used in accordance with the procedure laid down in Art. 11.

2. States Parties shall, as far as possible, inform the WHO within 24 hours of receipt of data establishing the existence, outside their territory, of a risk identified for public health which may be at the origin of the International spread of disease, as evidenced by export or import:

(a)

Human cases;

(b)

Vectors of infection or contamination; or

(c)

Of contaminated goods.

1. WHO, pursuant to s. 9, requests the State Party to verify reports from sources other than notifications or consultations, according to which events that could constitute an international public health emergency would occur on its Territory. In such cases, the WHO shall inform the State Party concerned of the reports it seeks to verify.

2. In accordance with the provisions of the preceding paragraph and of Art. 9, each State Party, at the request of the WHO, shall carry out the necessary checks and:

(a)

Provides a first response or acknowledgement of receipt of the request within 24 hours;

(b)

Provides within 24 hours the public health information available on the events referred to in the request of the WHO; and

(c)

Communicates information to the WHO in the context of the art assessment. 6, including the information described in this article.

When the WHO is informed of an event which may constitute a public health emergency of international concern, it proposes to collaborate with the State Party concerned in the assessment of the risk of international spread of diseases, of hindrance The international traffic that could be created and the adequacy of control measures. These activities may include collaboration with other standards organisations and the offer to mobilise international assistance in order to assist national authorities in leading and coordinating on-the-spot appraisals. At the request of the State Party, the WHO shall provide information in support of that offer.

4. If the State Party does not accept the offer of collaboration, the WHO may, where justified by the extent of the risk to public health, communicate to other States Parties the information available to it, while urging the State Party to Accept WHO's offer of collaboration, taking into account the views of the State Party concerned.

1. Subject to the provisions of subs. 2 of this Article, the WHO shall communicate to all States Parties and, as appropriate, the relevant intergovernmental organizations, as soon as possible and by the most effective means available, in a confidential manner, the information of Public health that she received pursuant to s. 5 to 10 and which are necessary to enable States Parties to address a risk to public health. WHO should provide information to other States Parties to assist them in preventing the occurrence of similar incidents.

2. WHO uses information received in application of art. 6 and 8 and para. 2 of the art. 9 for the purposes of verification, evaluation and assistance under this Regulation and, except where otherwise agreed with the States Parties referred to in those provisions, it shall generally not communicate this information to other States Parties before:

(a)

It is determined that the event constitutes an international public health emergency under s. 12; or

(b)

Information demonstrating the international spread of infection or contamination has been confirmed by WHO in accordance with established epidemiological principles; or

(c)

It is established that:

(i)

Measures against international spread are unlikely to succeed due to the nature of the contamination, the pathogen, the vector or the reservoir, or

(ii)

The State Party shall not have sufficient operational capacity to implement the measures necessary to prevent further spread of the disease; or

(d)

The nature and extent of the international movement of travellers, baggage, cargoes, containers, means of transport, goods or parcels that may be affected by infection or contamination require immediate implementation of International control measures.

The WHO shall consult the State Party on whose territory the event occurred with regard to its intention to provide information under this Article.

4. When communicating to the States Parties, in accordance with this Regulation, information which it has received pursuant to s. 2 of this article, the WHO may also make this information public if other information concerning the same event has already been published and if the dissemination of reliable and independent information is necessary.

The Director-General shall determine, on the basis of the information he receives, in particular from the State Party on whose territory an event occurs, whether an event constitutes an international public health emergency in respect of the Criteria and procedure set out in this Regulation.

(2) If the Director-General considers, on the basis of an assessment under this Regulation, that there is an international public health emergency, he shall consult the State Party on whose territory the event occurs in respect of This preliminary finding. If the Director General and the State Party agree to that conclusion, the Director General, in accordance with the procedure set out in Art. 49, seeks the views of the Committee established pursuant to Art. 48 (hereinafter referred to as the "Emergency Committee") Concerning the appropriate temporary recommendations.

3. If, following the consultation provided for in s. 2 above, the Director-General and the State Party on whose territory the event occurs does not agree within 48 hours on whether the event constitutes an international public health emergency, Decision shall be made in accordance with the procedure set out in Art. 49.

4. In determining whether an event is an international public health emergency, the Director General shall consider:

(a)

Information provided by the State Party;

(b)

The decision instrument contained in Annex 2;

(c)

The opinion of the Emergency Committee;

(d)

Scientific principles, as well as scientific evidence and other relevant information; and

(e)

An assessment of the risk to human health, the risk of international spread of diseases and the risk of obstacles to international traffic.

5. If the Director-General, after consulting the State Party on whose territory the international public health emergency has occurred, considers that the public health emergency of international scope has ended, he shall take a Decision in accordance with the procedure set out in Art. 49.

1. Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation in respect of that State Party, the ability to react promptly and effectively in the event of risk For public health and public health emergencies of international concern, as set out in Annex 1. WHO publishes, in consultation with Member States, guidelines to assist States Parties in acquiring the capacity for public health action.

2. As a result of the assessment under s. 2 of Part A of Annex 1, a State Party may report to the WHO on the grounds of a justified need and an action plan and, in so doing, obtain an additional period of two years to fulfil its obligation under s. 1 of this article. In exceptional circumstances and by submitting a new action plan, the State Party may request that the time limit be extended to the Director General for a further two years, taking the decision taking into account the technical advice of the Review Committee. After the period provided for in par. 1 of this Article, the State Party which has obtained an additional period shall report annually to the WHO on the progress made in the full implementation.

3. At the request of a State Party, WHO collaborates in the event of a risk to public health and other events by providing technical advice and assistance and assessing the effectiveness of the control measures put in place, Including, where appropriate, mobilizing international teams of experts to provide on-site assistance.

4. If the WHO, in consultation with the States Parties concerned in accordance with Art. 12, establishes that there is an international public health emergency, it may offer, in addition to the support indicated in s. 3 of this Article, additional assistance to the State Party, including an assessment of the seriousness of the international risk and the adequacy of control measures. As part of this collaboration, it may offer to mobilize international assistance to assist national authorities in the conduct and coordination of on-site evaluations. At the request of the State Party, the WHO shall provide information in support of that offer.

5. At the request of WHO, the States Parties shall, as far as possible, support the action coordinated by the WHO.

6. At their request, WHO offers to provide appropriate advice and assistance to other States Parties affected or threatened by the international public health emergency.

WHO shall cooperate and, where appropriate, coordinate its activities with other intergovernmental organizations and international bodies responsible for the implementation of this Regulation, in particular by similar agreements and arrangements.

2. In the event that the notification or verification of an event, or the action taken to deal with it, falls primarily within the competence of other intergovernmental organizations or international bodies, WHO coordinates its activities With such organizations or organizations for the purpose of implementing measures to protect public health.

Notwithstanding the above, no provision of this Regulation shall prevent or restrict the provision by WHO of advice, support or technical or other assistance for public health purposes.

1. If it has been established, pursuant to s. 12, that there is an international public health emergency, the Director General publishes temporary recommendations in accordance with the procedure set out in s. 49. These temporary recommendations may be amended or extended, depending on the case, particularly after it has been established that an international public health emergency has ceased, after which other temporary recommendations may be Published, as required, for the purpose of preventing or rapidly detecting a resurgence.

(2) The temporary recommendations may concern health measures to be implemented by the State Party in which the international public health emergency occurs, or by other States Parties, in respect of persons, baggage, Cargo, containers, means of transport, goods and/or parcel post to prevent or reduce the international spread of diseases and avoid unnecessary interference with international traffic.

3. Temporary recommendations may be cancelled at any time in accordance with the procedure set out in Art. 49 and automatically expire three months after publication. They may be amended or extended for additional periods of up to three months. Temporary recommendations cannot be maintained beyond the second World Health Assembly following the decision on the international public health emergency to which they relate.

WHO may make permanent recommendations for the systematic or periodic implementation of appropriate health measures in accordance with art. 53. Such measures may be applied by States Parties with regard to persons, baggage, cargoes, containers, means of transport, goods and/or parcel post in the event of specific persistent risks to public health for the purposes Prevent or reduce the international spread of diseases and avoid unnecessary obstacles to international traffic. The WHO may, by virtue of s. 53, amend these recommendations or cancel them, if applicable.

When formulating, amending or cancels temporary or permanent recommendations, the Director General shall take into account:

(a)

The views of the States Parties directly concerned;

(b)

The opinion of the Emergency Committee or the Review Committee, as appropriate;

(c)

Scientific principles and scientific evidence and information available;

(d)

Health measures which, on the basis of a risk assessment adapted to the situation, do not impede international trade and commerce and are no more intrusive to persons than other reasonably available measures which Provide the required health protection;

(e)

Relevant international standards and instruments;

(f)

Activities of other relevant intergovernmental organizations and international organizations; and

(g)

Other specific and appropriate information about the event.

In the case of temporary recommendations, the urgency of the situation may limit the Director-General's consideration of the elements referred to in paras. (e) and (f) of this article.

Recommendations addressed by the WHO to States Parties with regard to persons may include the following advice:

-

No specific health measures are recommended;

-

Review travel history in affected areas;

-

Review the evidence that a medical examination and laboratory analysis were conducted;

-

Require medical examinations;

-

Examine evidence of immunizations or other prophylactic measures;

-

Require vaccination or prophylactic measures;

-

Placing suspect persons under observation for public health purposes;

-

Quarantine or apply other health measures to suspect persons;

-

Isolate or treat affected persons if necessary;

-

Search for contacts of persons who are suspect or affected;

-

Deny entry to suspect and affected persons;

-

Deny entry of unassigned persons to affected areas; and

-

Screening people from affected areas and/or applying exit restrictions.

2. Recommendations addressed by the WHO to States Parties with regard to baggage, cargo, containers, means of transport, goods and parcel post may include the following advice:

-

No specific health measures are recommended;

-

Examine the manifest and the itinerary;

-

Conducting inspections;

-

Examine evidence of measures taken initially or during transit to eliminate infection or contamination;

-

Carry out the processing of baggage, cargo, containers, means of transport, goods, parcel post or human remains to eliminate infection or contamination, including vectors and reservoirs;

-

Apply specific health measures to ensure the safe handling and transport of human remains;

-

Isolation or quarantine;

-

Require, in the absence of effective treatment or processes, the seizure and destruction under the control of baggage, cargo, containers, means of transport, infected, contaminated or suspect goods or parcels; and

-

Deny departure or entry.

In addition to other obligations under this Regulation, each State Party shall:

(a)

Ensure that the capabilities set out in Schedule 1 relating to designated entry points are acquired within the time limits set out in s. 1 of the art. 5 and para. 1 of the art. 13;

(b)

Specifies the competent authorities at each entry point designated in its territory; and

(c)

Provides WHO, as far as possible when requested to address a potential public health risk, relevant data on sources of infection or contamination, including vectors and reservoirs, At its ports of entry, which may lead to the international spread of diseases.

States Parties shall designate airports and ports to acquire and maintain the capabilities provided for in Annex 1.

2. States Parties shall ensure that certificates of exemption from ship sanitary control and certificates of ship sanitary control are issued in accordance with the requirements of Art. 39 and the model set out in Annex 3.

Each State Party shall communicate to the WHO the list of ports entitled to propose:

(a)

The issue of the certificates of ship health control and the provision of the services referred to in Annexes 1 and 3; or

(b)

Only the issuance of certificates for exemption from ship sanitary control; and

(c)

The extension of the certificate of exemption from the sanitary control of a ship for a period of one month until the ship arrives in the port to which the certificate may be delivered.

Each State Party shall inform the WHO of any change in the status of the ports on the list. The WHO shall publish the information received pursuant to this paragraph.

4. The WHO may, at the request of the State Party concerned, take the necessary steps to certify, following an appropriate investigation, that an airport or port in the territory of that State Party meets the conditions set out in par. 1 and 3 of this article. WHO may periodically review such certifications in consultation with the State Party.

5. The WHO, in collaboration with intergovernmental organizations and relevant international bodies, shall develop and publish the guidelines for the certification of airports and ports referred to in this Article. WHO also publishes a list of certified airports and ports.

1. Where justified in relation to public health, a State Party shall designate the border posts which will acquire the capabilities provided for in Annex 1, taking into account:

(a)

The volume and frequency of the various types of international traffic at border posts which may be designated by a State Party, in relation to other entry points; and

(b)

Public health risks in areas from which international traffic originates, or passes through, prior to arrival at a particular border crossing.

2. States Parties with common borders should consider:

(a)

Enter into bilateral or multilateral agreements or arrangements concerning the prevention or control of international transmission of diseases at border crossings in accordance with art. 57; and

(b)

To jointly designate adjacent border posts for the capabilities described in Annex 1, in accordance with par. 1 of this article.

1. Competent authorities:

(a)

Ensure that luggage, cargo, containers, means of transport, goods and parcel post and human remains from affected areas are kept in a state such that they are free from sources of infection or Contamination, including vectors and reservoirs;

(b)

Ensure, as far as possible, that facilities used by travellers at ports of entry are maintained in good hygienic conditions and remain free from sources of infection or contamination, including vectors and Tanks;

(c)

Supervise the removal, disinfection, disinfecting or decontamination of baggage, cargo, containers, means of transport, goods, parcel post and human remains or health measures applied to persons, In accordance with this Regulation;

(d)

Warn the operators of means of transport, as far in advance as possible, of their intention to apply control measures to a means of transport, and provide them, where appropriate, with written information on the methods to be used. Use;

(e)

Supervise the hygienic removal and disposal of contaminated water or food, as well as human or animal excreta, waste water and any other contaminated material on board a conveyance;

(f)

Shall take all possible measures compatible with this Regulation to monitor and prevent the discharge by ships of waste water, waste, ballast water and other potentially pathogenic materials that could contaminate the water A port, river or canal, strait, lake or other international waterway;

(g)

Are responsible for the supervision of service providers concerning travellers, baggage, cargoes, containers, means of transport, goods and parcel post and human remains at ports of entry, including the conduct of Inspections and medical examinations as required;

(h)

Provide for effective emergency provisions to deal with an unforeseen event affecting public health; and

(i)

Communicate with the national RSI focal point about relevant public health measures taken pursuant to this Regulation.

2. Health measures recommended by WHO for travellers, baggage, cargoes, containers, means of transport, goods, parcel post and human remains from an affected area may be applied again upon arrival There are verifiable indications and/or evidence that the measures applied at the start of the affected area have failed.

3. Decontamination, deratification, disinfection, decontamination and any other sanitary procedures shall be carried out in such a way as to avoid causing injury and, as far as possible, an inconvenience to persons or damage to the environment Damage to public health, or damage to luggage, cargo, containers, means of transport, goods and parcel post.

No health document other than those provided for in this Regulation or by WHO recommendations shall be required in international traffic, provided, however, that this Article does not apply to travellers seeking a Authorisation for temporary or permanent residence, nor does it apply to documents relating to the public health status of goods

Or cargo entering the international trade required by the applicable international agreements. The competent authority may require travellers to complete forms of contact information and health questionnaires, provided that the conditions set out in s. 23.

1. The vaccines and prophylaxis measures administered to travellers under this Regulation or of the recommendations, and the related certificates, shall be in accordance with the provisions of Annex 6 and, if applicable, Annex 7 concerning Certain diseases.

2. A traveller with a certificate of vaccination or a certificate attesting to another measure of prophylaxis issued in accordance with the provisions of Annex 6 and, if applicable, of Annex 7, shall not be refused due to the disease referred to in the Certificate, even if it comes from an affected area, unless the competent authority has verifiable indications and/or evidence that vaccination or prophylaxis has not had an effect.

1. Prior to its first port of call in the territory of a State Party, the master of a ship shall ensure the state of health on board and, unless requested by that State Party, he shall complete and deliver to the competent authority of the port, on arrival or before arrival If the ship is equipped with the necessary equipment and if the State Party requires that it be given to it in advance, a Maritime Declaration of Health which is countersigned by the flight surgeon, if there is one.

2. The master or, if there is one, the flight surgeon, shall provide the competent authority with all information on the state of health on board during the international voyage.

3. The Marine Health Declaration must be consistent with the model set out in Appendix 8.

4. A State Party may decide:

(a)

Not to require all vessels upon arrival to submit the Maritime Declaration of Health; or

(b)

To require the presentation of the Maritime Health Declaration pursuant to a recommendation concerning ships from affected areas or to require ships that may otherwise carry a source of infection or Contamination.

The State Party shall inform the operators of vessels or their representatives of such requirements.

(1) In flight or landing on the first airport of the territory of a State Party, the commander of an aircraft or his representative shall perform his best and shall deliver to the competent authority of that airport, unless that State Party so requires, The part of the General Aircraft Declaration on Health Issues, which must conform to the model set out in Annex 9.

(2) The commander of an aircraft or his representative shall provide the State Party with all the information it requests on the state of health on board during the international voyage and on the health measures that may be applied to the aircraft.

A State Party may decide:

(a)

Not to require all aircraft upon arrival to present the portion of the General Aircraft Declaration relating to health matters; or

(b)

Require the submission of the portion of the General Statement of Aircraft relating to health matters pursuant to a recommendation concerning aircraft coming from affected areas or requiring aircraft that may otherwise be Carriers of a source of infection or contamination.

The State Party shall inform aircraft operators or their representatives of such requirements.

1. Ships sanitary exemption certificates and ship health control certificates are valid for a maximum of six months. This period of validity may be extended by one month if the inspection or control measures required cannot be carried out at the port.

2. If a certificate of exemption from the sanitary control of a ship or a certificate of health control of a valid ship cannot be produced or if the existence on board of a risk to public health is established, the State Party may proceed as Indicated in par. 1 of the art. 27.

3. The certificates referred to in this Article shall conform to the model set out in Annex 3.

4. Whenever possible, control measures shall be implemented when the ship and the holds are empty. If the ship is on ballast, they are carried out prior to loading.

5. Where control measures are required and have been implemented satisfactorily, the competent authority shall issue a certificate of sanitary control of a ship, in which the signs and measures of control are noted Applied.

6. The competent authority may issue a certificate of exemption from the sanitary control of a ship in any port referred to in s. 20 if she is satisfied that the vessel is free of infection and contamination, including vectors and reservoirs. Such a certificate is normally issued only if the inspection of the ship was carried out while the ship and the holds were empty or contained only ballast or other material of that nature or disposed of in such a way that an inspection Full of the holds was possible.

7. If the conditions under which control measures are applied are such that, in the opinion of the competent authority of the port where the operation is carried out, a satisfactory result cannot be obtained, the competent authority shall include a note to This effect on the ship's health control certificate.

1. Except for travellers who apply for temporary or permanent residence permits, and subject to s. 2 of this Article, the State Party shall not collect any other rights under this Regulation for the following measures to protect public health:

(a)

Any medical examination provided for in this Regulation, or any further examination, which may be required by the State Party in order to ascertain the health of the traveller under examination;

(b)

Any vaccination or other measure of prophylaxis given to a traveller on arrival, that is not subject to a published prescription or that has been prescribed published less than 10 days prior to the administration of vaccination or Another measure of prophylaxis;

(c)

Appropriate isolation or quarantine measures imposed on a traveller;

(d)

Any certificate issued to the traveler stating the measures applied and the date of application; or

(e)

Any health measures relating to baggage accompanying travellers.

2. States Parties may levy fees for health measures other than those referred to in s. 1 of this article, including those applied primarily in the interest of the traveller.

3. If rights are levied for the application of these health measures to travellers under this Regulation, there shall be only one tariff in each State Party for those rights, which shall all:

(a)

Are in accordance with this tariff;

(b)

Do not exceed the actual cost of the service provided; and

(c)

Are collected irrespective of the nationality, domicile or place of residence of the travellers concerned.

4. The tariff, and any amendment thereto, shall be published at least ten days before the collection of any right contained therein.

5. Nothing in this Regulation shall prevent States Parties from seeking reimbursement of expenses incurred as a result of the health measures referred to in s. 1 of this article:

(a)

To operators or owners of means of transportation with respect to their employees; or

(b)

To the insurers concerned.

Travellers or operators of means of transport shall in no case be denied the possibility of leaving the territory of a State Party pending the settlement of the rights referred to in s. 1 and 2 of this article.

(1) If duties are levied for the application of health measures to baggage, cargo, containers, means of transport, goods or parcels under this Regulation, there shall be in each State Party only one tariff for These rights, which all:

(a)

Are in accordance with this tariff;

(b)

Do not exceed the actual cost of the service provided; and

(c)

Are collected irrespective of nationality, flag, registration or owner of luggage, cargoes, containers, means of transport, postal goods or parcels concerned. In particular, no distinction is made between luggage, cargoes, containers, means of transport, domestic and foreign goods or parcels.

2. The tariff, and any amendment thereto, shall be published at least ten days before the collection of any right contained therein.

Health measures taken under this Regulation shall be implemented and carried out without delay and applied in a transparent and non-discriminatory manner.

1. This Regulation shall not prevent States Parties from applying, in order to deal with specific risks to public health or public health emergencies of international concern, health measures in accordance with their Applicable national law and its obligations under international law which:

(a)

Provide a level of health protection that is identical to or superior to the recommendations of the WHO; or

(b)

Are otherwise prohibited by s. 25, art. 26, paras. 1 and 2 of Art. 28, art. 30, para. 1 (c) of Art. 31 and art. 33;

Provided that such measures are otherwise compatible with this Regulation.

Such measures shall not be more restrictive for international traffic or more intrusive or invasive for persons than other reasonably applicable measures that would ensure the appropriate level of health protection.

2. The States Parties shall base their decision on the implementation of the sanitary measures referred to in s. 1 of this art. Or other health measures referred to in s. 2 of the art. 23, para. 1 of the art. 27, para. 2 of the art. 28 and para. 2 (c) of art. 31 on:

(a)

Scientific principles;

(b)

The available scientific evidence indicating a risk to human health or, if insufficient, the available information, including from WHO and other intergovernmental organizations and international bodies Competent; and

(c)

Any specific advice or advice available from WHO.

(3) A State Party that applies the additional sanitary measures referred to in s. 1 of this article, which significantly impeding international traffic, provides the WHO with public health reasons and the scientific information that justifies it. WHO shall communicate this information to other States Parties and shall provide information on the health measures applied. For the purposes of this Article, significant interference generally refers to the refusal to allow entry or departure of international travellers, baggage, cargo, containers, means of transport, goods and related objects, or Deferral of more than 24 hours of entry or departure.

4. After evaluating the information provided pursuant to s. 3 and 5 of this Article and other relevant information, the WHO may request the State Party concerned to reconsider the appropriateness of applying the measures.

5. A State Party that applies the additional sanitary measures referred to in s. 1 and 2 of this Article which significantly impede international traffic shall inform the WHO, within 48 hours of their implementation, of such measures and their health justification unless they are the subject of a Temporary or permanent recommendation.

6. A State Party that applies a sanitary measure under s. 1 or by. 2 of this article shall review it within three months, taking into account the advice of the WHO and the criteria set out in s. 2 of this article.

7. Without prejudice to the rights conferred on it by s. 56, any State Party which suffers the consequences of a measure taken under s. 1 or by. 2 of this Article may request the State Party applying this measure to consult it in order to clarify the scientific information and the public health reasons underlying the measure and find a solution Acceptable to both States Parties.

8. The provisions of this Article may apply to the implementation of measures concerning travellers taking part in large gatherings.

1. The States Parties undertake to cooperate with each other, to the extent possible, for:

(a)

Detect, evaluate and respond to events in accordance with these Regulations;

(b)

To ensure or facilitate technical cooperation and the provision of logistical support, in particular for the acquisition, strengthening and maintenance of public health capacity in accordance with this Regulation;

(c)

To mobilize financial resources to facilitate the implementation of their obligations under this Regulation; and

(d)

To formulate draft laws and other legal and administrative provisions for the purposes of this Regulation.

2. WHO shall, to the extent possible, collaborate with the States Parties to:

(a)

Assess and assess their public health capacity in order to facilitate the effective implementation of this Regulation;

(b)

Ensure or facilitate technical cooperation and the provision of logistical support to States Parties; and

(c)

Mobilize financial resources that will help developing countries acquire, strengthen and maintain the capabilities set out in Annex 1.

The collaboration provided for in this article can be implemented at multiple levels, including bilaterally, through regional networks and WHO regional offices, and through intergovernmental organizations And international organizations.

1. Health information collected or received by a State Party of another State Party or of the WHO pursuant to this Regulation and which relates to an identified or identifiable person shall be kept confidential and treated in a manner As provided for in national legislation.

2. Notwithstanding s. 1, States Parties may disclose and use personal data if this is necessary to assess and manage a risk to public health, but States Parties, in accordance with national legislation, and WHO ensure that That this data:

(a)

Shall be treated impartially and in accordance with the law and shall not be used in a manner inconsistent with that purpose;

(b)

Be adequate, relevant and do not exceed what is necessary for this purpose;

(c)

Be accurate and, if applicable, up to date; all reasonable steps must be taken to ensure that inaccurate or incomplete data are erased or corrected;

(d)

Are not stored any longer than is necessary.

3. WHO shall, as far as possible, provide to the person concerned the request for the personal data referred to in this Article, in an intelligible form, without undue delay or expense, and, if necessary, Make corrections.

In accordance with national legislation and applicable international guidelines, States Parties shall facilitate the transport, entry, exit, treatment and disposal of biological substances, diagnostic specimens, Reagents and other diagnostic equipment for the purposes of verification and action required by this Regulation.

1. The States Parties and the Director General shall report to the Assembly of Health on the implementation of this Regulation according to the decision of the Health Assembly.

2. The Assembly of Health shall periodically review the operation of this Regulation. To this end, it may seek advice from the Review Committee through the Director General. The first of these examinations shall take place no later than five years after the entry into force of this Regulation.

3. The WHO shall conduct periodic studies to examine and evaluate the operation of Annex 2. The first of these reviews shall be undertaken not later than one year after the entry into force of this Regulation. The results of these reviews shall be submitted, as appropriate, to the consideration of the Health Assembly.

1. Any State Party or the Director General may propose amendments to this Regulation. These amendments are submitted to the Health Assembly for consideration.

2. The text of any proposed amendment shall be communicated to all States Parties by the Director General at least four months before the Health Assembly to which this amendment is submitted for consideration.

3. The amendments to this Regulation adopted by the Assembly of Health pursuant to this Article shall enter into force in respect of all States Parties under the same conditions and subject to the same rights and obligations as those provided for in Art. 22 of the WHO Constitution and art. 59 to 64 of this Regulation.

1. If a dispute arises between two or more States Parties concerning the interpretation or application of this Regulation, the States Parties concerned shall first endeavour to settle them by negotiation or by any other peaceful means of their choice, Including through the use of good offices or mediation by a third party or conciliation. In the event of failure, the parties to the dispute remain obliged to continue their efforts to reach a settlement.

2. If the dispute is not resolved by means at par. 1 of this Article, the States Parties concerned may agree to refer the dispute to the Director General, who shall make every effort to resolve the dispute.

A State Party may at any time declare in writing to the Director General that it agrees to submit to binding arbitration all disputes concerning the interpretation or application of this Regulation to which it is a party or a dispute The opponent to any other State Party which accepts the same obligation. Arbitration shall be conducted in accordance with the Optional Rules of the Permanent Court of Arbitration for Arbitration of Disputes between two States in force on the date of submission of the Request for Arbitration. States Parties which have agreed to accept arbitration as compulsory shall accept the arbitral award as binding and final. The Director-General shall inform the Assembly of the Health if necessary.

4. None of the provisions of this Regulation shall affect the right of States Parties under any international agreement to which they are parties to resort to the dispute settlement mechanisms established by others Intergovernmental organizations or under an international agreement.

5. In the event of a dispute between the WHO and one or more States Parties concerning the interpretation or application of this Regulation, the matter shall be referred to the Health Assembly.

States Parties recognize that the IHR and other relevant international agreements shall be interpreted in such a way as to ensure their compatibility. The provisions of the IHR shall not affect the rights and obligations of States Parties arising from other international agreements.

2. Subject to subs. 1 of this Article, no provision of this Regulation shall prohibit States Parties which have certain common interests because of their health, geographical, social or economic situation to enter into separate treaties or arrangements for Facilitate the application of this Regulation, in particular as regards:

(a)

The direct and rapid exchange of information on public health between neighbouring territories of different states;

(b)

Sanitary measures applicable to international coastal traffic and international traffic in waters under their jurisdiction;

(c)

Health measures applicable in the contiguous territories of different states on their common borders;

(d)

The organisation of the transport of affected persons or human remains affected by a specially adapted means of transport; and

(e)

Deratification, disinfestation, disinfection, decontamination or any other treatment designed to make goods free of pathogens.

3. Without prejudice to their obligations under this Regulation, States Parties which are members of a regional economic integration organization shall apply the common rules in force within that organisation within the framework of their Mutual relations.

1. Subject to the provisions of s. 62 and the following exceptions, this Regulation shall replace between the States which it binds and between these States and the WHO the provisions of the following international health agreements and regulations:

(a)

International Health Convention, signed at Paris on 21 June 1926;

(b)

International Health Convention for Air Navigation, signed at The Hague on 12 April 1933;

(c)

International Agreement Concerning the Removal of Medical Patents, signed at Paris on 22 December 1934;

(d)

International Agreement Concerning the Removal of Consular Visas on Health Patents, signed at Paris on 22 December 1934;

(e)

Convention amending the International Health Convention of 21 June 1926, signed at Paris on 31 October 1938;

(f)

International Health Convention of 1944 amending the Convention of 21 June 1926, opened for signature in Washington on 15 December 1944;

(g)

International Health Convention for Air Navigation of 1944 amending the Convention of 12 April 1933, opened for signature in Washington on 15 December 1944;

(h)

Protocol of 23 April 1946 extending the International Health Convention of 1944, signed in Washington;

(i)

Protocol of 23 April 1946 extending the International Health Convention for Air Navigation of 1944, signed in Washington;

(j)

1951 International Health Regulations ¹ Additional Regulations, 1955, 1956, 1960, 1963 and 1965; and

(k)

International Health Regulations, 1969 ² And amendments from 1973 and 1981.

2. The Pan American Health Code, signed at Havana on 14 November 1924, remains in force, with the exception of art. 2, 9, 10, 11, 16 to 53 inclusive, 61 and 62, to which the relevant provisions of s. 1 of this article.

1. The period prescribed in s. 22 of the Constitution of the WHO to refuse this Regulation or an amendment thereto or to make reservations to it shall be 18 months from the date of notification by the Director General of the adoption of this Regulation or of the amendment thereof To this Regulation by the Health Assembly. A refusal or reservation received by the Director General after the expiration of that period shall have no effect.

2. This Regulation shall enter into force 24 months after the date of notification referred to in par. 1 of this article except in respect of:

(a)

A State which has refused the Regulation or an amendment to it in accordance with Art. 61;

(b)

A State which has made a reservation, and in respect of which the Regulation enters into force as provided for in Art. 62;

(c)

Of a State which becomes a Member of the WHO after the date of the notification by the Director General referred to in s. 1 of this Article and which is not already a party to this Regulation, in respect of which the Regulation enters into force as provided for in Art. 60; and

(d)

Of a Member State which is not a Member of the WHO but which accepts this Regulation and in respect of which it enters into force in accordance with paragraph 1. 1 of the art. 64.

3. If a State is unable to adjust its national legislative and administrative provisions within the period laid down in par. 2 of this Article in order to bring them into full compliance with this Regulation, it shall send it to the Director General within the period specified in par. 1 of this Article a declaration concerning the remaining adjustments and shall make such adjustments no later than 12 months after the entry into force of this Regulation in respect of that State Party.

Any State which becomes a Member of the WHO after the date of notification by the Director General referred to in s. 1 of the art. 59, and which is not already a Party to this Regulation, may indicate that it refuses or has reservations within a period of twelve months from the date of the notification addressed to it by the Director General after it has become Member of WHO. Subject to the provisions of Art. 62 and 63, and except in the case of refusal, this Regulation shall enter into force in respect of that State at the expiration of the said time limit. This Regulation shall not enter into force in respect of that State less than 24 months after the date of the notification referred to in par. 2 of the art. 59.

If a State notifies the Director General of its refusal of this Regulation or of an amendment thereof within the time limit laid down in par. 1 of the art. 59, this Regulation or the amendment concerned shall not enter into force in respect of that State. Any international agreement or health regulation referred to in s. 58 to which that State is already a Party shall remain in force in respect of that State.

(1) Any State may make reservations to the Regulations under this Article. Such reservations shall not be incompatible with the object and purpose of this Regulation.

2. Any reservation to this Regulation shall be notified to the Director General in accordance with the provisions of s. 1 of the art. 59 and art. 60, para. 1 of the art. 63 or par. 1 of the art. 64 as applicable. A non-WHO Member State shall notify the Director General of any reservations it makes in its notification of acceptance of this Regulation. Any State which formulates reservations must make known the reasons to the Director General.

3. A partial refusal of this Regulation or an amendment to it is equivalent to a reservation.

4. Pursuant to the provisions of s. 2 of the art. 65, the Director General shall notify any reservations received under subs. 2 of this article. The Director General shall:

(a)

If the reservation has been formulated before the entry into force of this Regulation, requests those Member States which have not refused this Regulation to make known to it within six months any objection that they would have to oppose to that reservation; or

(b)

If the reservation has been formulated after the entry into force of this Regulation, requests the States Parties to make known to it within six months any objections that they would have to oppose to that reservation.

States objecting to a reservation must indicate the reasons for the objection to the Director General.

(5) After this period, the Director-General shall notify all States Parties of the objections received concerning reservations. If, at the end of the period of six months from the date of the notification referred to in par. 4 of this Article, one third of the States referred to in s. 4 of this Article shall not object to the reservation, it shall be deemed to be accepted and this Regulation shall enter into force with respect to the reserving State, with the exception of the provisions which are the subject of the reservation.

6. If at least one third of the States referred to in par. 4 of this Article shall preclude a reservation before the expiry of the period of six months from the date of the notification referred to in par. 4 of this Article, the Director General shall notify the reserving State so that it intends to withdraw its reservation within three months from the date of the notification addressed to it by the Director General.

7. The reserving State shall continue to fulfil all obligations relating to the subject matter of the reservation which it has accepted in the context of an international health agreement or regulation referred to in Art. 58.

8. If the reserving State does not withdraw the reservation within a period of three months from the date of the notification by the Director General referred to in subs. 6 of this Article, and if requested by the reserving State, the Director General shall request the opinion of the Review Committee. The Review Committee shall inform the Director General, as soon as possible and in accordance with the provisions of Art. 50, the practical impact of the reservation on the application of this Regulation.

9. The Director General shall submit the reservation and the opinion of the Review Committee, if any, to the Health Assembly for its consideration. If the Assembly of Health, by a simple majority vote, objects to the reservation on the ground that it is incompatible with the object and purpose of this Regulation, the reservation shall not be accepted and this Regulation shall not enter into force in respect of The reserving State only after it has withdrawn its reservation in accordance with Art. 63. If the Health Assembly accepts the reservation, this Regulation shall enter into force with respect to the reserving State with that reservation.

1. A refusal issued under s. 61 may, at any time, be withdrawn by a State with a notification addressed to the Director General. In such case, the Regulation shall enter into force in respect of that State on the date of receipt by the Director General of the notification, unless the State issues a reservation when it withdraws its refusal, in which case the Regulation shall enter into force as provided for in the Art. 62. In no case shall the Regulation enter into force in respect of that State before a period of 24 months after the date of the notification referred to in par. 1 of the art. 59.

(2) All or part of a reservation may at any time be withdrawn by the State Party concerned by notification addressed to the Director General. In such case, the withdrawal shall take effect as from the date of receipt by the Director General of the notification.

1. Non-WHO Member States, but which are Parties to an international health agreement or regulation referred to in Art. 58 or to which the Director General has notified the adoption of this Regulation by the World Health Assembly, may become a Party to this Regulation by notifying its acceptance to the Director General. Subject to the provisions of Art. 62, this acceptance shall take effect on the date of entry into force of this Regulation or, if notified after that date, three months after the date of receipt by the Director General of that notification.

2. States not Members of the WHO which have become Parties to this Regulation may at any time denounce their participation in this Regulation by a notification addressed to the Director General; such denunciation shall take effect six months after receipt of the Notification. The State which has denounced its participation shall once again apply the provisions of any international health agreement or regulation referred to in Art. 58 to which it was previously a Party.

(1) The Director General shall notify the adoption of this Regulation by the Assembly of Health to all Member States and Associate Members of WHO, as well as to other Parties to any international health agreement or regulation referred to in Art. 58.

2. The Director General shall also notify these States, as well as any other State which has become a Party to this Regulation or any amendment to this Regulation, of any notification received by the WHO pursuant to s. 60 to 64, respectively, and any decision taken by the Health Assembly pursuant to s. 62.

The English, Arabic, Chinese, English, French and Russian texts of this Regulation shall be equally authentic. The original texts of this Regulation shall be deposited in the WHO archives.

2. Certified true copies of this Regulation shall be sent by the Director General to all Members and Associate Members, as well as to other Parties to any international agreement or health regulations referred to in Art. 58, with the notification provided for in para. 1 of the art. 59.

3. At the time of entry into force of this Regulation, the Director General shall transmit certified copies thereof to the Secretary-General of the United Nations for registration, in accordance with art. 102 of the United Nations Charter ¹ .