EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 02004R0851-20221226
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
Consolidated text: 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
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
02004R0851 — EN — 26.12.2022 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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 (OJ L 142 30.4.2004, p. 1) |
Amended by:
|
|
Official Journal |
||
No |
page |
date |
||
REGULATION (EU) 2022/2370 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 November 2022 |
L 314 |
1 |
6.12.2022 |
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
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
‘competent body’ means any structure, institute, agent or other scientific body recognised by Member States’ authorities as providing independent scientific and technical advice or capacity for action in the field of the prevention and control of human disease;
‘coordinating competent body’ means a body in each Member State with a designated national coordinator responsible for institutional contacts with the Centre, as well as national focal points and operational contact points responsible for strategic and operational collaboration on scientific and technical issues for specific disease areas and public health functions;
‘dedicated network’ means any specific network on diseases, related special health issues or public health functions that is supported and coordinated by the Centre and is intended to ensure collaboration between the coordinating competent bodies of the Member States;
‘communicable disease’ means a communicable disease as defined in Article 3, point (3), of Regulation (EU) 2022/2371 of the European Parliament and of the Council ( 1 );
‘serious cross-border threat to health’ means a serious cross-border threat to health as defined in Article 3, point (1), of Regulation (EU) 2022/2371;
‘epidemiological surveillance’ means epidemiological surveillance as defined in Article 3, point (5), of Regulation (EU) 2022/2371;
‘related special health issues’ means related special health issues as referred to in Article 2(1), point (a)(ii), of Regulation (EU) 2022/2371;
‘monitoring’ means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371;
‘health system capacity’ means health system capacity as defined in Article 3, point (13), of Regulation (EU) 2022/2371.
Article 3
Mission and tasks of the Centre
In the case of other outbreaks of diseases of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that is clearly not of a communicable disease, the Centre shall act only in cooperation with the coordinating competent bodies and upon their request, and provide a risk assessment.
In pursuing its mission, the Centre shall respect the responsibilities of the Member States, the Commission and other Union bodies or agencies, and the responsibilities of third countries and international organisations active within the field of public health, in particular the WHO, in order to ensure that there is comprehensiveness, coherence and complementarity of action and that actions are coordinated.
The Centre shall support the work of the Health Security Committee (HSC), established by Article 4 of Regulation (EU) 2022/2371, the Council, the Member States and, where relevant, other Union structures, in order to promote effective coherence between their respective activities and to coordinate responses to serious cross-border threats to health, within its mandate.
The Centre shall perform the following tasks:
search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, using the most effective technologies, such as, where relevant, artificial intelligence, respecting European standards regarding ethical aspects;
develop, in close collaboration and consultation with Member States, relevant common indicators for standardised data collection procedures and risk assessments;
provide analyses, scientific and technical advice, opinions, guidelines, science-based recommendations and support for actions by the Union and Member States, to prevent and control communicable diseases and related special health issues, including risk assessments, analysis of epidemiological information, prevention, preparedness and response planning and epidemiological modelling, anticipation and forecasting;
promote and coordinate the networking of bodies, organisations and experts operating in the Union in the fields relevant to the Centre’s mission, including networks arising from public health activities supported by the Commission, and operate dedicated networks on surveillance, while ensuring full compliance with the rules on transparency and conflicts of interest;
promote and facilitate the exchange of scientific and technical information and expertise and of best practices, including through training, among Member States and other Union agencies and bodies;
monitor, in close cooperation with Member States, their health system capacity and support the collection of data on their health system capacity to the extent necessary for the management of and response to communicable disease threats and related special health issues, based on the preparedness indicators referred to in Article 5b(2), point (b), of this Regulation and the elements set out in Article 7(1) of Regulation (EU) 2022/2371.
organise on-site visits in Member States, on a case-by-case basis, in close collaboration with the Member States concerned, to provide additional support to prevention, preparedness and response planning activities as referred to in Article 5b;
support national monitoring of response to major communicable diseases;
contribute to defining research priorities and to facilitating the development and implementation of actions funded by relevant Union funding programmes and instruments, including the implementation of joint actions in the area of public health;
provide, at the request of the Commission or the HSC, or on its own initiative, guidelines, recommendations and proposals for coordinated action for surveillance, monitoring, diagnosis and case management of communicable diseases and related special health issues, and support for professional networks to improve treatment guidelines in cooperation with relevant organisations and associations, national competent bodies and international organisations such as the WHO, while avoiding any duplication of existing guidelines;
support, for example through the EU Health Task Force referred to in Article 11a, epidemic and outbreak response in Member States, based on in-depth country knowledge, and in third countries in cooperation with the WHO, in a manner that is complementary to, and in close coordination with, other emergency response instruments, in particular the Union Civil Protection Mechanism, and relevant instruments on the stockpiling of medical countermeasures;
contribute to strengthening preparedness capacities under the IHR, including training, in Member States and in third countries, in particular partner countries, while ensuring that synergies with the work of the WHO are achieved;
provide, at the request of the Commission or the HSC, or on its own initiative, timely, easily accessible and evidence-based communication messages to the public, in all official languages of the Union, on communicable diseases and threats to health posed by communicable diseases, as well as on the relevant prevention and control measures, with due regard for the competences of the Member States.
Article 4
Obligations of Member States
Member States shall coordinate and collaborate with the Centre, in relation to the mission and tasks set out in Article 3, by:
communicating regularly to the Centre, in accordance with agreed timelines, case definitions, indicators, standards, protocols and procedures, data on the surveillance of communicable diseases, related special health issues and other serious cross-border threats to health undertaken in accordance with Article 13 of Regulation (EU) 2022/2371, and available scientific and technical data and information necessary for the Centre to fulfil its mission referred to in Article 3(2), point (e), of this Regulation, including relevant data on the capacity of health systems for crisis preparedness in relation to detecting, preventing, responding to and recovering from outbreaks of communicable diseases;
notifying the Centre of any serious cross-border threats to health, as soon as detected, through the Early Warning and Response System (EWRS) provided for under Article 18 of Regulation 2022/2371, and promptly communicating any response measures taken, as well as any relevant information that is useful for coordinating the response as referred to in Article 21 of that Regulation;
identifying, within the scope of the mission of the Centre, competent bodies and public health experts and organisations that could be available to assist in the Union response to serious cross-border threats to health, such as by undertaking missions to Member States, cross-border regions and third countries in cooperation with the WHO, in order to provide expert advice and carry out field investigations in the event of disease clusters or outbreaks;
preparing national prevention, preparedness and response plans in accordance with Article 6 of Regulation (EU) 2022/2371 and reporting on prevention, preparedness and response planning and implementation at national level in accordance with Article 7 of that Regulation;
facilitating the digitalisation of data collection and the data communication process between national and European surveillance systems to provide timely delivery of the necessary information; and
informing the Centre about any delay in meeting the timelines referred to in point (a).
CHAPTER 2
OPERATIONAL PROCEDURES
Article 5
Operation of dedicated networks and networking activities
It shall in particular:
ensure the continuous development of automated digital platforms and applications, including the digital platform for surveillance established under Article 14 of Regulation (EU) 2022/2371, that are subject to human oversight, support epidemiological surveillance at Union level, and support Member States with scientific and technical data and advice to establish integrated surveillance systems enabling real-time surveillance for preparedness, where appropriate and feasible, benefiting from existing Union space infrastructure and services;
provide quality assurance by monitoring and evaluating the epidemiological surveillance activities of the dedicated networks on surveillance to ensure optimal operation, including by developing surveillance standards and monitoring data completeness and indicators;
maintain databases for such epidemiological surveillance, coordinate with the hosts of other relevant databases and work towards harmonised approaches to data collection and modelling in order to produce comparable Union-wide data; in carrying out that role, the Centre shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, and shall establish robust procedures for data quality review;
communicate the results of the analysis of data to the Commission, the HSC and the Member States, make databases accessible to and usable by Member States to support national policymaking and bilateral and multilateral collaboration between Member States, and propose communication messages to Member States to inform the public;
promote and support harmonised and rationalised operating methodologies for epidemiological surveillance in collaboration with the competent bodies;
ensure the interoperability of automated applications and other digital tools that support cross-border public health activities, including for contact tracing and warning applications, developed at Union level or national level in close collaboration with Member States;
ensure the interoperability of the digital platforms for surveillance with digital infrastructure enabling health data to be used for healthcare, research, policy-making and regulatory purposes, and make use of other relevant data, for example environmental factors or phenomena with the potential to have a severe impact on health at Union or cross-border interregional level, or socio-economic risk factors, among others, if useful as regards fulfilling the Centre’s mission more effectively.
The digital platforms and applications referred to in the second subparagraph, point (a), shall be implemented with privacy-enhancing technologies taking into account the state of the art.
The Centre, through the operation of the network for epidemiological surveillance, shall:
monitor and report on trends in communicable diseases over time and across Member States and in third countries in cooperation with the WHO, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from Member States;
detect, monitor and report on serious cross-border threats to health referred to in Article 2(1), points (a)(i) and (a)(ii), of Regulation (EU) 2022/2371, including threats to substances of human origin, or in Article 2(1), point (d), of that Regulation, with regard to source, time, population and place in order to provide a rationale for public health action;
support the national reference laboratories referred to in Article 15 of Regulation (EU) 2022/2371 in the implementation of the external quality control schemes, including professional testing schemes;
contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for science-based recommendations to strengthen and improve those programmes at Union and national level;
monitor and assess the capacity of health systems to diagnose, prevent and treat major communicable diseases, as well as the resilience of the national health systems in the event of major disease outbreaks, based on preparedness indicators referred to in Article 5b(2), point (b);
identify population groups at risk and in need of targeted prevention and response measures, and support Member States in ensuring that those measures also target persons with disabilities;
contribute to the assessment of the burden of communicable diseases, such as with regard to disease prevalence, clinical complications, hospitalisation and mortality, by using among other types of data, stratified data on age, gender, disability and other elements, if available;
carry out epidemiological modelling, anticipation and scenario development for response, and coordinate such efforts with a view to exchanging best practices, improving modelling capacity across the Union and ensuring international cooperation; and
identify risk factors for disease transmission and the associated disease burden, provide analysis of the correlation between disease transmission, on the one hand, and social, economic, climatic and environmental risk factors, on the other, following the ‘One Health’ approach for zoonotic, food and waterborne diseases and other relevant diseases and special health issues, and identify population groups most at risk, including the correlation between disease incidence and severity with societal and environmental factors, and research priorities and needs.
The national focal points shall form networks that provide scientific and technical advice to the Centre.
National focal points and operational contact points designated for disease-specific interactions with the Centre shall form disease-specific or disease-group-specific networks whose tasks shall include the transmission of national surveillance data as well as the submission of proposals for the prevention and control of communicable diseases to the Centre.
Member States shall notify the Centre and other Member States of the designations provided for in this paragraph and of any change thereto.
Article 5a
Prevention of communicable diseases
Article 5b
Prevention, preparedness and response planning
The Centre shall, in close collaboration with the Member States and the Commission:
without prejudice to Member States’ competences in the area of prevention, preparedness and response planning, contribute to the development, regular review and updating of frameworks for national preparedness plans and of threat-specific preparedness plans for adoption by the HSC, and to the development, regular review and updating of the Union prevention, preparedness and response plan in accordance with Article 5 of Regulation (EU) 2022/2371;
develop preparedness, monitoring and evaluation frameworks, and develop indicators for preparedness based on the IHR, in cooperation with the WHO, which frameworks and indicators are to be discussed within the HSC;
facilitate self-assessments by Member States of their prevention, preparedness and response planning and external evaluation of such planning, when accepted by the Member State concerned and in a manner that is complementary to the IHR, and contribute to the activities referred to in Articles 7 and 8 of Regulation (EU) 2022/2371;
ensure assessment of preparedness gaps and the provision of targeted support to Member States and, at their request and in cooperation with the WHO, to third countries that conclude agreements with the Union in accordance with Article 30;
develop exercises, stress tests, in-action and after-action reviews, and support and complement Member States in those activities, and organise additional actions to address gaps identified in preparedness capacity and capability;
develop and support specific preparedness activities addressing, amongst other things, vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity, based on identified gaps or at the request of the Member States or the Commission;
support the integration of research preparedness in the prevention, preparedness and response plans;
support and complement additional targeted activities addressing at-risk groups and community preparedness;
based on indicators referred to in Article 3(2), point (b), and in point (b) of this subparagraph, and in close cooperation with the Member States, monitor the capacity of Member States’ health systems to detect, prevent, respond to and recover from outbreaks of communicable diseases, identify gaps and provide science-based recommendations for the strengthening of health systems, to be implemented with Union support, as appropriate;
bolster the modelling, anticipation and forecasting capacity of the Centre; and
maintain regular secondment mechanisms between the Centre, the Commission, Member States’ experts and international organisations, including a EU Health Task Force, which support the activities referred to in points (d), (f), (h) and (i) of this subparagraph and Article 5a(1).
The secondment mechanisms referred to in the first subparagraph, point (k), shall contribute to the strengthening of the operational interface between the Centre and Member States.
Article 6
Scientific opinions and studies
To promote and initiate the studies referred to in the first subparagraph, the Centre shall request access to health data made available or exchanged through digital infrastructure and applications, so that such health data can be used for healthcare, health research, policy-making and regulatory purposes linked to public health.
For the purposes of the studies referred to in the first subparagraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors.
Article 7
Procedure for scientific opinions
The Centre shall issue a scientific opinion on matters falling within its mission:
in all cases where Union legislation provides that the Centre is to be consulted;
at the request of the European Parliament or a Member State;
at the request of the Commission, the HSC or EMA; and
on its own initiative.
Article 8
Operation of the Early Warning and Response System
The Centre shall:
analyse the content of messages it receives via the EWRS;
provide information, expertise, advice, training and risk assessments to Member States and the Commission; and
ensure that the EWRS is efficiently and effectively linked with other Union alert systems.
Article 8a
Public health risk assessment
Risk assessments referred to in paragraph 1 shall include general and targeted science-based recommendations and options for response as a basis for coordination in the HSC, such as concerning:
a forecast of the evolution of a health crisis and the risk of a health emergency;
the Member States’ health system capacity to the extent it is necessary for the management of and the response to communicable disease threats and related special health issues, in order to support Member States;
identification of vulnerable groups in society;
identification of possible protective non-pharmaceutical measures and assessment of their efficacy.
The Centre shall establish rules of procedure for risk assessments, especially regarding the involvement of experts to ensure that Member State expertise is independent and representative.
The Centre shall work together with Member States to improve their risk assessment capacity.
Article 8b
Response coordination
The Centre shall support response coordination in the HSC as referred to in Article 21 of Regulation (EU) 2022/2371, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), of that Regulation, including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of that Regulation, in particular by providing science-based recommendations and options for:
national or cross-border interregional responses to the serious cross-border threat to health;
the adoption of guidelines for the Member States for the prevention and control of the serious cross-border threat to health.
Article 9
Scientific and technical assistance and training
Article 10
Identification of emerging health threats
Article 11
Collection and analysis of data
The Centre shall:
coordinate standardisation of data collection procedures, and validation, analysis and dissemination of data at Union level;
seek, where appropriate, the expertise and guidance of the Member States to ensure that there is a correct understanding of the health data made available, their limitations and the national context and information systems.
The Centre shall collect data and information, and provide links to relevant research data and outputs on:
epidemiological surveillance;
the progression of epidemic situations, including for modelling, anticipation and scenario development and the assessment of vulnerable groups;
unusual epidemic phenomena or new communicable diseases of unknown origin, including those in third countries, in cooperation with the WHO;
pathogen data, including at molecular level, if required for epidemiological surveillance and for detecting or investigating serious cross-border threats to health;
health systems data required for managing communicable diseases and related special health issues; and
implementation of the Centre’s recommendations by Member States and the outcomes thereof.
For the purposes of paragraph 1, the Centre shall:
develop, together with the competent bodies of the Member States and the Commission, appropriate procedures to facilitate consultation and data transmission and access;
carry out scientific and technical evaluations of prevention and control measures at Union level;
work in close cooperation and in a transparent manner with relevant bodies operating in the field of data collection of the Union, third countries, the WHO and other international organisations;
develop solutions to access relevant health data, whether publicly available or made available or exchanged through digital infrastructure, in order to allow the health data to be used for healthcare, health research, policy-making and regulatory purposes linked to public health; and provide and facilitate controlled and timely access to health data to support public health research.
Article 11a
Support for international and field preparedness and response
The Centre shall develop capacities to conduct field epidemiology and research, and gather relevant data, such as on the variants of communicable diseases, using the dedicated network of EU reference laboratories or its own resources.
At the joint request of the Commission and Member States, the enhanced emergency capacity of the EU Health Task Force shall be mobilised. The Commission shall, by means of implementing acts, adopt the procedures concerning the mobilisation of the enhanced emergency capacity of the EU Health Task Force. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30a(2).
Article 12
Communications on the activities of the Centre
The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to its activities and the results of its work. The Centre shall make scientific information available to the general public, including through a dedicated website, as well as through an active presence on social media or analogous platforms. It shall also publish its scientific opinions, produced in accordance with Article 6, in a timely manner. Information relevant for citizens of the Union shall be made available in all the official languages of the Union to ensure appropriate outreach to citizens of the Union. The Centre shall facilitate the fight against misinformation regarding vaccination and against the causes of vaccine hesitancy.
CHAPTER 3
ORGANISATION
Article 13
Bodies of the Centre
The Centre shall comprise:
a management board;
a director and his/her staff;
an advisory forum.
Article 14
Management Board
Alternates who represent the member in his/her absence shall be appointed by the same procedure.
Members’ term of office shall be three years and may be extended.
The Management Board shall elect one of its members as its Chair for a two-year period, which shall be extendable.
The Management Board shall meet at least twice a year at the invitation of the Chair, or at the request of at least a third of its members.
The Management Board shall:
exercise disciplinary authority over the director and appoint or dismiss him/her pursuant to Article 17;
ensure that the Centre carries out its mission and performs the tasks assigned to it under the conditions laid down in this Regulation including on the basis of regular independent and external evaluations to be carried out every five years;
compile a list of competent bodies referred to in Article 5 and make it public;
adopt, before 31 January each year, the Centre’s work programme for the coming year;
adopt a draft single programming document in line with Article 32 of Commission Delegated Regulation (EU) 2019/715 ( 3 ) and the related Commission guidelines for the single programming document; the single programming document shall be adopted where a positive opinion has been given by the Commission and, as regards multiannual programming, after consulting the European Parliament and the Council;
ensure that the Centre’s work programme for the coming year and multiannual programmes are consistent with the Union’s legislative and policy priorities in the area of the Centre’s mission and tasks, and fully take into account the recommendations adopted in the annual Commission opinion on the draft single programming document referred to in Article 32(7) of Delegated Regulation (EU) 2019/715;
adopt, before 31 March each year, the general report on the Centre’s activities for the previous year;
adopt the financial rules applicable to the Centre after the Commission has been consulted;
determine by unanimity of its members, by way of derogation from Article 15(1), the rules governing the languages of the Centre, including the possibility of a distinction between the internal workings of the Centre and the external communication, taking into account the need to ensure access to, and participation in, the work of the Centre by all interested parties in both cases.
The financial rules applicable to the Centre as referred to in the first subparagraph, point (h), of this paragraph shall not derogate from Delegated Regulation (EU) 2019/715, unless specifically required for the Centre’s operation and the Commission has given its prior consent.
Article 15
Voting
Article 16
Director
The director shall be the legal representative of the Centre and shall be responsible for:
the day-to-day administration of the Centre;
drawing up draft work programmes, taking into account the recommendations adopted in the annual Commission opinion on the draft single programming document in accordance with Article 32(7) of Delegated Regulation (EU) 2019/715; the Commission opinion shall be submitted to the Management Board at the earliest possible stage;
preparation of discussions within the Management Board;
implementing the work programmes and the decisions adopted by the Management Board;
ensuring the provision of appropriate scientific, technical and administrative support for the Advisory Forum;
ensuring that the Centre carries out its tasks in accordance with the requirements of its users, in particular with regard to the scientific excellence and independence of activities and opinions, the adequacy of the services provided and the time taken;
preparing the statement of revenue and expenditure and executing the budget of the Centre;
all staff matters, and in particular the exercise of powers laid down in Article 29(2).
Each year, the director shall submit to the Management Board for approval:
a draft general report covering all the activities of the Centre in the previous year;
draft work programmes;
the draft annual accounts for the previous year;
the draft budget for the coming year.
Article 17
Appointment of the director
Article 18
Advisory Forum
The Advisory Forum shall constitute a mechanism for an exchange of information on health threats and the pooling of knowledge. It shall ensure close cooperation between the Centre and the competent bodies in the Member States in particular on the following items:
coherence of the Centre’s scientific studies with Member States;
in those circumstances where the Centre and a national body cooperate;
the promoting, starting up and supervising of the European networks within the fields of the Centre’s mission;
where the Centre or a Member State identifies an emerging public health threat;
the setting up of scientific panels by the Centre;
scientific and public health priorities to be addressed in the work programme; and
key publications under preparation by the Centre, such as forecasting studies.
CHAPTER 4
TRANSPARENCY AND CONFIDENTIALITY
Article 19
Declaration of interest
Article 20
Transparency and protection of information
▼M1 —————
Article 20a
Personal data protection
Article 21
Professional secrecy and confidentiality
The Commission’s rules on security regarding the protection of EU classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 ( 7 ) and (EU, Euratom) 2015/444 ( 8 ), shall apply to the work of the Centre and its staff.
CHAPTER 5
FINANCIAL PROVISIONS
Article 22
Drawing-up of the budget
The revenue of the Centre shall, without prejudice to other resources, comprise:
a subsidy from the Community entered in the general budget of the European Union (Commission section);
payments received for services rendered;
any financial contributions from the competent bodies referred to in Article 5;
any voluntary contribution from the Member States; and
any revenue from contribution agreements or grant agreements exceptionally concluded between the Commission and the Centre.
Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 23
Implementation of the Centre’s budget
The Centre shall inform the Commission without delay of cases of presumed fraud and other financial irregularities, of any completed or ongoing investigations by the European Public Prosecutor’s Office (EPPO) or the European anti-Fraud Office (OLAF), and of any audits or controls by the Court of Auditors or the Internal Audit Service (IAS), without endangering the confidentiality of the investigations. That obligation to inform the Commission is without prejudice to Article 24(1) of Council Regulation (EU) 2017/1939 ( 11 ).
Article 24
Application of the Financial Regulation
Article 70 of Regulation (EU, Euratom) 2018/1046 shall apply to the discharge of the Centre’s budget, its audits and accounting rules.
Article 25
Combating fraud
CHAPTER 6
GENERAL PROVISIONS
Article 26
Legal personality and privileges
Article 27
Liability
Article 28
Examination of legality
Article 29
Staff
Article 30
Participation of third countries
Article 30a
Committee procedure
Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
CHAPTER 7
FINAL PROVISIONS
Article 31
Review clause
By 2025, the Commission shall submit a report to the European Parliament, the Council and the Management Board on the Centre’s activities, including an assessment of:
how the Centre progressed with implementing the amended mandate in light of the COVID-19 pandemic;
the Centre’s compliance with the obligations laid down in Regulation (EU) 2022/2371 and other relevant Union legislation;
how effectively the Centre’s activities address international, Union or national health priorities;
the extent to which the work of the Centre is targeted at and affects Member States’ capacities.
The report shall reflect the views of the stakeholders, at both Union and national level.
The report shall be accompanied by an independent study commissioned by the Commission.
The independent external evaluation shall, in particular, address the possible need to amend the mandate of the Centre and the financial implications of any such amendment. The first evaluation shall examine the feasibility of extending the mandate of the Centre to address the impact of cross-border threats to health on non-communicable diseases.
The Management Board shall examine the conclusions of the independent external evaluation and may issue recommendations, if necessary, to the Commission regarding changes in the Centre, its working practices and the scope of its mission. The Commission shall forward the evaluation report and the recommendations to the European Parliament and the Council.
Article 32
Commencement of the Centre’s operation
The Centre shall be operational by 20 May 2005.
Article 33
Entry into force
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
( 1 ) Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26.).
( 2 ) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
( 3 ) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1).
( 4 ) OJ L 145, 31.5.2001, p. 43.
( 5 ) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regards to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
( 6 ) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
( 7 ) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
( 8 ) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
( 9 ) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).
( 10 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
( 11 ) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
( 12 ) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
( 13 ) OJ L 136, 31.5.1999, p. 15.
( 14 ) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).