# L_2009110EN.01005801.xml

| 1.5.2009 | EN | Official Journal of the European Union | L 110/58 |
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1.5.2009

EN

Official Journal of the European Union

L 110/58

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COMMISSION DECISION

of 30 April 2009

amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council

(notified under document number C(2009) 3517)

(Text with EEA relevance)

(2009/363/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (1), and in particular Article 3(c) thereof,

Whereas:

| (1) | According to point 2.1 of Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (2), ‘diseases preventable by vaccination’, including ‘influenza’, are covered by epidemiological surveillance in the Community network pursuant to Decision No 2119/98/EC. |
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(1)

According to point 2.1 of Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (2), ‘diseases preventable by vaccination’, including ‘influenza’, are covered by epidemiological surveillance in the Community network pursuant to Decision No 2119/98/EC.

| (2) | According to Article 2 of Commission Decision 2002/253/EC of 19 March 2002 laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (3), the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data. |
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(2)

According to Article 2 of Commission Decision 2002/253/EC of 19 March 2002 laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (3), the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.

| (3) | Several cases of a novel influenza virus have been reported in North America and more recently in several Member States. This virus is one of the multiple forms that can take the disease ‘influenza’, listed in Annex I to Decision 2000/96/EC. However, given that this new virus poses a risk of a pandemic influenza and requires an immediate coordination between the Community and the national competent authorities, it is necessary to provide for a specific case definition differentiating it from the more general case definition of influenza, that will enable the national competent authorities to communicate relevant information to the Community network pursuant to Article 4 of Decision No 2119/98/EC. |
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(3)

Several cases of a novel influenza virus have been reported in North America and more recently in several Member States. This virus is one of the multiple forms that can take the disease ‘influenza’, listed in Annex I to Decision 2000/96/EC. However, given that this new virus poses a risk of a pandemic influenza and requires an immediate coordination between the Community and the national competent authorities, it is necessary to provide for a specific case definition differentiating it from the more general case definition of influenza, that will enable the national competent authorities to communicate relevant information to the Community network pursuant to Article 4 of Decision No 2119/98/EC.

| (4) | In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (4) (ECDC), the ECDC provided, at the request of the Commission, a technical document on the case definition for this communicable disease assisting the Commission and Member States in the development of intervention strategies in the field of surveillance and response. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution. |
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(4)

In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (4) (ECDC), the ECDC provided, at the request of the Commission, a technical document on the case definition for this communicable disease assisting the Commission and Member States in the development of intervention strategies in the field of surveillance and response. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution.

| (5) | The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 7 of Decision No 2119/98/EC, |
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(5)

The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 7 of Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Decision 2002/253/EC is completed by the additional case definition contained in the Annex to the present Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 30 April 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 268, 3.10.1998, p. 1.

1

(2)  
  OJ L 28, 3.2.2000, p. 50.

2

(3)  
  OJ L 86, 3.4.2002, p. 44.

3

(4)  
  OJ L 142, 30.4.2004, p. 1.

4

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ANNEX

The following wording is inserted in the Annex to Decision 2002/253/EC:

‘NOVEL INFLUENZA VIRUS A(H1N1) (THE SO-CALLED SWINE INFLUENZA VIRUS A(H1N1) AND MEXICAN INFLUENZA VIRUS) (1)

Clinical criteria

Any person with one of the following three:

| — | fever > 38 °C AND signs and symptoms of acute respiratory infection, |
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fever > 38 °C AND signs and symptoms of acute respiratory infection,

| — | pneumonia (severe respiratory illness), |
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pneumonia (severe respiratory illness),

| — | death from an unexplained acute respiratory illness. |
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death from an unexplained acute respiratory illness.

Laboratory criteria

At least one of the following tests:

| — | RT-PCR, |
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RT-PCR,

| — | viral culture (requiring BSL 3 facilities), |
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viral culture (requiring BSL 3 facilities),

| — | four-fold rise in novel influenza virus A(H1N1) specific neutralising antibodies (implies the need for paired sera, from acute phase illness and then at convalescent stage 10-14 days later minimum). |
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four-fold rise in novel influenza virus A(H1N1) specific neutralising antibodies (implies the need for paired sera, from acute phase illness and then at convalescent stage 10-14 days later minimum).

Epidemiological criteria

At least one of the following three in the seven days before disease onset:

| — | a person who was a close contact to a confirmed case of novel influenza A(H1N1) virus infection while the case was ill, |
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a person who was a close contact to a confirmed case of novel influenza A(H1N1) virus infection while the case was ill,

| — | a person who has travelled to an area where sustained human-to-human transmission of novel influenza A(H1N1) is documented, |
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a person who has travelled to an area where sustained human-to-human transmission of novel influenza A(H1N1) is documented,

| — | a person working in a laboratory where samples of the novel influenza A(H1N1) virus are tested. |
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a person working in a laboratory where samples of the novel influenza A(H1N1) virus are tested.

Case classification

A.   Case under investigation

Any person meeting the clinical and epidemiological criteria.

B.   Probable case

Any person meeting the clinical AND epidemiological criteria AND with a laboratory result showing positive influenza A infection of an unsubtypable type.

C.   Confirmed case

Any person meeting the laboratory criteria for confirmation.

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(1)  The name will be changed in line with the definition provided by the World Health Organisation.’.’

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