Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006
The Management Board shall elect a Chairperson and a Deputy Chairperson from among its members with the right to vote. The Chairperson and the Deputy Chairperson shall be elected by a majority of two-thirds of the members of the Management Boards with the right to vote.
The Deputy Chairperson shall automatically replace the Chairperson if she or he is prevented from attending to her or his duties.
The term of office of the Chairperson and the Deputy Chairperson shall be four years. Their term of office may be renewed once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically expire on that date.
The detailed procedure for the election of the Chairperson and the Deputy Chairperson shall be set out in the rules of procedure of the Management Board.
Article 26
Meetings of the Management Board
The Chairperson shall convene the meetings of the Management Board.
The Executive Director shall take part in the deliberations of the Management Board.
The Management Board shall hold at least one ordinary meeting a year. In addition, it shall meet on the initiative of its Chairperson, at the request of the Commission, or at the request of at least one-third of its members.
The Management Board may invite any person, including representatives from civil society organisations, whose opinion may be of interest to attend its meetings as an observer.
The members of the Management Board may, subject to its rules of procedure, be assisted at the meetings by advisers or experts.
The Agency shall provide the secretariat for the Management Board.
Article 27
Voting rules of the Management Board
Without prejudice to Article 24(1), points (c) and (d), Article 25(1), Article 35(6), Article 29(8) and Article 53(2), the Management Board shall take decisions by a majority of its members with the right to vote.
Each member with the right to vote shall have one vote. In the absence of a member with the right to vote, her or his alternate shall be entitled to exercise the right to vote.
The Chairperson and Deputy Chairperson shall take part in the voting.
The Executive Director shall not take part in the voting.
The Management Board’s rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member.
Article 28
Executive Board
The Executive Board shall:
(a) decide on those matters provided for in the financial rules adopted pursuant to Article 42 that are not reserved to the Management Board by this Regulation;
(b) ensure adequate follow up to the findings and recommendations stemming from internal or external audit reports and evaluations, and from investigations by OLAF and by EPPO, as referred to in Article 48;
(c) without prejudice to the responsibilities of the Executive Director, set out in Article 30, monitor and supervise the implementation of the decisions of the Management Board, with a view to reinforcing supervision of administrative and budgetary management.
Where necessary, because of urgency, the Executive Board may take certain provisional decisions instead of the Management Board, in particular on administrative management matters, including the suspension of the delegation of the appointing authority powers and budgetary matters. The conditions for taking such provisional decisions shall be set out in the rules of procedure of the Management Board.
The Executive Board shall be composed of the Chairperson and the Deputy Chairperson of the Management Board, two other members appointed by the Management Board from among its members with the right to vote and the two representatives of the Commission to the Management Board.
The Chairperson of the Management Board shall also be the Chairperson of the Executive Board.
The Executive Director shall take part in the meetings of the Executive Board as an observer. The Executive Board may invite other observers to attend its meetings.
The term of office of members of the Executive Board shall be four years. Their term of office may be renewed once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office in the Executive Board shall automatically expire on that date.
The Executive Board shall hold at least two ordinary meetings a year. In addition, it shall meet on the initiative of its Chairperson or at the request of its members.
The Executive Board shall take its decision by consensus among its members. If the Executive Board is not in a position to take a decision by consensus, the matter shall be referred to the Management Board.
The Management Board shall lay down the rules of procedure of the Executive Board.
Article 29
Executive Director
The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants.
The Management Board shall appoint the Executive Director from a list of at least three candidates proposed by the Commission on the basis of an open and transparent selection procedure. The selection procedure shall include the publication of a call for expressions of interest in the Official Journal of the European Union and in other appropriate media. The Commission shall consult the Management Board on the draft call for expressions of interest. The Commission may include a representative of the Management Board as an observer in the selection procedure.
Before appointment by the Management Board to the post of Executive Director, the shortlisted candidates proposed by the Commission may be invited, without delay, to make a statement before the competent committee or committees of the European Parliament and answer questions from the committee members. After hearing the statement and the responses, the European Parliament may adopt an opinion setting out its views and submit it to the Management Board.
For the purpose of concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.
The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director’s performance, including prior input from the Management Board, and the Agency’s future tasks and challenges.
The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Executive Director once for a period of no more than five years.
The Management Board shall inform the European Parliament if it intends to extend the Executive Director’s term of office. Before the Management Board takes a decision to extend the Executive Director’s term of office, the Executive Director may be invited to make, without delay, a statement before the competent committee or committees of the European Parliament and answer questions from the committee members.
An Executive Director whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period.
The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission. The European Parliament and the Council shall be informed, in a manner that complies with the applicable confidentiality requirements, about the reasons for such a decision.
The Management Board shall reach decisions on the appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with the right to vote.
Article 30
Responsibilities of the Executive Director
The Executive Director shall be responsible for the management of the Agency. The Executive Director shall be accountable to the Management Board.
Without prejudice to the powers of the Commission, of the Management Board and of the Executive Board, the Executive Director shall be independent in the performance of her or his duties and shall neither seek nor take instructions from any government or from any other body.
The Executive Director shall report to the European Parliament on the performance of her or his duties when invited to do so. The Council may invite the Executive Director to report on the performance of her or his duties.
The Executive Director shall be the legal representative of the Agency.
The Executive Director shall be responsible for the implementation of the Agency’s specific tasks set out in Article 5. In particular, the Executive Director shall be responsible for:
(a) the day-to-day administration of the Agency;
(b) preparing and implementing the decisions adopted by the Management Board;
(c) preparing the single programming document referred to in Article 36 and submitting it to the Management Board after consulting the Commission;
(d) implementing the single programming document and reporting to the Management Board on its implementation;
(e) preparing the Agency’s consolidated annual activity report and presenting it to the Management Board for assessment and adoption;
(f) proposing to the Management Board the level of co-financing referred to in Article 33(5), where such co-financing is to be granted to the national focal points;
(g) proposing to the Management Board the method for calculating fees and the way fees are paid in accordance with Article 38;
(h) preparing a follow-up action plan in relation to the conclusions of internal or external audit reports and evaluations, and to investigations by OLAF and EPPO, as referred to in Article 48, and reporting on progress twice a year to the Commission and regularly to the Management Board and the Executive Board;
(i) protecting the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities, without prejudicing the investigative competence of OLAF and EPPO, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative penalties and by reporting any criminal conduct to the EPPO in accordance with Article 24 of Regulation (EU) 2017/1939 in respect of which the EPPO could exercise its competence;
(j) preparing an anti-fraud strategy and efficiency gains and synergies strategies for the Agency and presenting them to the Management Board for approval;
(k) preparing the draft for the financial rules applicable to the Agency;
(l) preparing the Agency’s draft statement of estimates of revenue and expenditure and implementing its budget.
The Executive Director may decide to post one or more liaison officers to the Union institutions and to relevant Union bodies, offices and agencies for the purpose of carrying out the Agency’s tasks in an efficient and effective manner. The Executive Director shall obtain the prior consent of the Commission and the Management Board. Decisions to post liaison officers shall specify, in a manner that avoids unnecessary costs and a duplication of the administrative functions of the Agency, the scope of the activities to be carried out by the liaison officers.
Where called upon by the European Parliament or by the Council, the Executive Director shall attend, without undue delay, meetings organised by the European Parliament or the Council, as the case may be, on any subject related to the Agency’s mandate.
Article 31
Scientific Committee
The Scientific Committee shall be composed of no less than seven and no more than 15 scientists appointed by the Management Board in view of their scientific excellence and their independence, following the publication of a call for expressions of interest in the Official Journal of the European Union and in other appropriate media. The Agency shall inform the competent committee or committees of the European Parliament of appointments to the Scientific Committee and about its work. The procedure for selecting members of the Scientific Committee shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency. The parties involved in appointing members to the Scientific Committee shall aim to achieve gender-balanced representation in the Scientific Committee.
The members of the Scientific Committee shall be appointed in their personal capacity for a four-year period, which shall be renewable once.
The members of the Scientific Committee shall be independent and shall act in the public interest. They shall neither seek nor take instructions from any government or from any other body.
Where a member no longer meets the criteria of independence, she or he shall inform the Management Board. Alternatively, the Management Board may declare, on a proposal of at least one-third of its members or of the Commission, that there is a lack of independence on the part of a member and revoke the appointment of that member. The Management Board shall appoint a new member for the remaining term of office of that member in accordance with the ordinary procedure for the appointment of members.
The Scientific Committee shall deliver an opinion where provided for in this Regulation or on any scientific matter concerning the Agency’s activities which the Management Board or the Executive Director may submit to it. The opinions of the Scientific Committee shall be published on the Agency’s website.
For the purpose of assessing the risks posed by a new psychoactive substance or a group of new psychoactive substances, the Scientific Committee may be extended as considered necessary by the Executive Director, acting on the advice of the Chairperson of the Scientific Committee, by including experts representing the scientific fields relevant for ensuring a balanced assessment of the risks posed by the new psychoactive substance or the group of new psychoactive substances. The Executive Director shall designate those experts from a list of experts. The Management Board shall approve the list of experts every four years.
The Scientific Committee shall elect a Chairperson and a Deputy Chairperson for the duration of the mandate of the Scientific Committee. The Chairperson may participate as an observer in the meetings of the Management Board.
The Scientific Committee shall meet at least once a year.
The list of members of the Scientific Committee shall be made public and shall be updated by the Agency on its website.
Article 32
The European Information Network on Drugs and Drug Addiction
Through the European Information Network on Drugs and Drug Addiction (the ‘Reitox network’) the Member States shall contribute to the Agency’s task of collecting and reporting consistent and standardised information on the drugs phenomenon across the Union. The Reitox network shall consist of the national focal points designated in accordance with Article 33 and a focal point for the Commission.
The Reitox network shall elect a Spokesperson and between one and three Deputy Spokespersons from among its members. The Spokesperson shall represent the Reitox network in relation to the Agency and shall be allowed to participate as an observer in the meetings of the Management Board.
The Reitox network shall hold at least one ordinary meeting a year. The Agency shall convene and chair the meetings. In addition, the Reitox network shall meet on the initiative of its Spokesperson or at the request of at least one-third of its members.
Article 33
National focal point
Each participating country shall designate a single national focal point, set up through appropriate national legal or administrative measures on a permanent basis and with a clear mandate. The designation of a national focal point and the appointment of the head of a national focal point, as well as any changes to those appointments, shall be communicated to the Agency through the national member of the Management Board.
The responsible national authority shall ensure that the national focal point is entrusted with the tasks set out in Article 34(2). The head of the national focal point or an alternate shall represent the national focal point in the Reitox network.
National focal points shall be scientifically independent and ensure the quality of their data.
National focal points shall plan their activities in advance and shall have adequate budgetary and human resources allocated by national budgets and co-financed by the Agency in accordance with paragraph 5 of this Article to fulfil their mandate and carry out their tasks set out in Article 34(2), and shall have sufficient equipment and facilities to support their daily activities.
The core costs of the national focal point of each Member State shall be co-financed through a grant provided by the Agency provided that it complies with the conditions set out in paragraphs 1 to 4. In order to receive that co-financing, the national focal point shall sign a grant agreement with the Agency on an annual basis. The level of co-financing shall be proposed by the Executive Director, approved by the Management Board and regularly reviewed. The Agency may provide additional funding to national focal points on an ad hoc basis for the participation in and delivery of specific projects.
The Agency shall assess national focal points in accordance with Article 35.
Article 34
Tasks of the national focal points
The national focal points shall form the interface, and support interactions, between the participating countries and the Agency.
With a view to supporting the Agency in achieving its general and specific tasks set out in Articles 4 and 5, respectively, thus contributing to coordinated Union action, each national focal point shall carry out the following tasks:
(a) for the purpose of communicating those data to the Agency, coordinate at national level the activities related to drug-related data collection and monitoring;
(b) collect relevant national data and information in the areas covered by Article 4 in accordance with the national reporting package referred to in Article 6(2) and transmit it to the Agency; in doing so, the national focal point shall bring together experience from different sectors, in particular health, justice and law enforcement, and shall, wherever relevant, cooperate with experts and national organisations, the scientific community, civil society organisations and other relevant stakeholders active in the field of drugs policy;
(c) contribute to monitoring drugs and drug use and reporting thereon, including to international organisations;
(d) support, as appropriate, the development of new epidemiological data sources to further the timely reporting of trends in substance use;
(e) support ad hoc and targeted data collection exercises in relation to new health and security threats;
(f) provide the Agency with information on new trends and challenges in the use of existing psychoactive substances or new combinations of psychoactive substances which pose a potential risk to health and with information on possible measures related to health;
(g) contribute to the exchange of information on, and the early warning system for, new psychoactive substances, in accordance with Chapter III;
(h) contribute to the establishment of relevant indicators and other relevant datasets, including guidelines for their implementation, with a view to obtaining reliable and comparable information at Union level, in accordance with Article 6;
(i) nominate, when requested by the Agency, national experts for specific discussions on relevant indicators and for other ad hoc and targeted data collection exercises;
(j) promote the use of the internationally agreed data collection protocols and standards to monitor drugs and drug use in the country;
(k) present an annual report of its activities to the Agency and other relevant stakeholders;
(l) implement quality assurance mechanisms to ensure the reliability of the data and information it obtains.
In accordance with their capacity, the national focal points shall monitor, analyse and interpret relevant information in the areas covered by Article 4. The national focal points shall provide that information and information on policies and solutions applied to the Agency.
The national focal points shall establish and maintain the necessary cooperation with relevant national and regional authorities, bodies, agencies and organisations for the collection of the information they need to carry out their tasks pursuant to paragraph 2.
When collecting data pursuant to this Article, the national focal points shall ensure, where possible, that the data collected are disaggregated by sex or gender. The national focal points shall consider the gender-sensitive aspects of drugs policy when collecting and presenting data pursuant to this Article. The national focal points shall not transmit any data which would make it possible to identify individuals or small groups of individuals. They shall refrain from transmitting any information relating to specific individuals.
Article 35
Assessment of the national focal points
The Agency shall assess whether each national focal point, by carrying out the tasks set out in Article 34(2), contributes to the achievement of the tasks of the Agency. Such assessments shall not concern other functions of the body hosting the national focal point or the overall structure in which the national focal point is embedded.
The assessment referred to in paragraph 1 shall be based on relevant information to be provided by the national focal point. If necessary, the Agency may visit the national focal point.
The Agency shall present each assessment it carries out pursuant to paragraph 1 to the national focal point and national competent authority concerned. Assessments may include recommendations for carrying out the tasks set out in Article 34(2), set a timeline for their implementation and offer support from the Agency to national focal points for the purposes of capacity building.
Where recommendations, together with a timeline for their implementation, have been issued pursuant to paragraph 3, the national focal point concerned shall either inform the Agency that it has accepted the recommendations or, in the event of disagreement, provide the Agency with a written reasoned opinion.
The Agency shall inform the Management Board of the outcome of assessments carried out pursuant to paragraph 1 at its first meeting following the completion of the assessment by the Agency. In the event of disagreement between the Agency and the national focal point as referred to in paragraph 4 of this Article, the Agency shall submit the assessment, the recommendations and the timeline for their implementation for the approval of the Management Board at its next meeting by a majority of its members with the right to vote in accordance with Article 23. The representative of the Member State concerned shall not take part in that vote.
If, by the time specified in an assessment as referred to in paragraph 1, the national focal point does not fulfil the tasks set out in Article 34(2), the Management Board shall take a decision, at its first meeting following the time specified in the assessment by a majority of two-thirds of members with the right to vote, in accordance with Article 23, as to whether not to provide co-financing until the national focal point carries out the tasks set out in Article 34(2). The representative of the Member State concerned shall not take part in that vote.
The first assessment pursuant to paragraph 1 of each national focal point shall be carried out by the Agency by 3 July 2026. Thereafter, the Agency shall assess national focal points at regular intervals, as necessary.
CHAPTER VI
Financial provisions
Article 36
Single programming document
By 15 December of each year, the Management Board shall adopt a draft single programming document containing multiannual and annual programming and the documents listed in Article 32 of Commission Delegated Regulation (EU) 2019/715 (30), based on a draft put forward by the Executive Director, after consulting the Scientific Committee, taking into account the opinion of the Commission, and, in relation to multiannual programming, after consulting the European Parliament. Where the Management Board decides not to follow elements of the opinion of the Commission or elements arising following the consultation of the European Parliament or of the Scientific Committee, it shall provide a justification. The Management Board shall forward the single programming document to the European Parliament, the Council and the Commission by 31 January of the following year.
The Single Programming Document shall become final once the general budget of the Union has been definitively adopted and shall, if necessary, be adjusted accordingly.
The annual work programme shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be coherent with the multiannual work programme referred to in paragraph 4. It shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year.
Multiannual or annual programming shall include information about the implementation of the international cooperation framework referred to in Article 20(1), point (a), and the actions linked to that framework. It shall also include the Agency’s planned research and innovation activities referred to in Article 21.
The Management Board shall amend the adopted annual work programme when a new task is given to the Agency.
Any substantial amendment to the annual work programme shall be adopted by the same procedure as the initial annual work programme. The Management Board may delegate the power to make non-substantial amendments to the annual work programme to the Executive Director.
The multiannual work programme shall set out overall strategic programming including objectives, expected results and performance indicators. It shall also set out resource programming, including the multiannual budget and staff.
The resource programming shall be updated annually. The strategic programming shall be updated where appropriate and, in particular, to address the outcome of the evaluation referred to in Article 51.
The multiannual and annual work programmes shall be prepared in compliance with Article 32 of Delegated Regulation (EU) 2019/715.
Article 37
Budget
Estimates of all revenue and expenditure for the Agency shall be prepared each financial year, corresponding to the calendar year, and shall be shown in the Agency’s budget.
The Agency’s budget shall be balanced in terms of revenue and of expenditure.
Without prejudice to other resources, the Agency’s revenue shall comprise:
(a) a contribution from the Union entered in the general budget of the Union;
(b) any voluntary financial contribution from the Member States;
(c) the fees paid for services rendered in accordance with Article 38;
(d) any financial contributions from the organisations and bodies and third countries referred to in Articles 53 and 54, respectively; and
(e) Union funding under indirect management or in the form of ad hoc grants in accordance with the financial rules applicable to the Agency and with the provisions of the relevant instruments supporting the policies of the Union.
The amount and origin of any revenue as referred to in paragraph 3, points (b) to (e), shall be included in the annual accounts of the Agency and clearly detailed in the annual report on the Agency’s budgetary and financial management referred to in Article 41(3).
The expenditure of the Agency shall include staff remuneration, administrative and infrastructure expenses, and operating costs. The operating costs may include expenditure in support of the national focal points, as referred to in Article 33(5).
Article 38
Fees
The Agency may deliver upon request the following additional services:
(a) customised training;
(b) certain support activities for Member States that have not been identified as a priority but could be beneficially conducted if supported by national resources;
(c) capacity-building programmes for third countries which are not covered by separate dedicated Union funding;
(d) assessment of national bodies set up in third countries, in particular candidate countries, pursuant to Article 20(3);
(e) other customised services rendered at the request of a participating country which require the investment of additional resources in the support of national activities. The Agency shall charge fees for the delivery of services as referred to in the first subparagraph.
At the proposal of the Executive Director and after having consulted the Commission, the Management Board shall set, in a transparent manner, the method for calculating the fees and the way in which they are paid.
Fees shall be proportionate to the costs of the service delivered as provided in a cost-effective way and shall be sufficient to cover those costs. Fees shall be set at such a level as to ensure that they are non-discriminatory and that they avoid placing an undue financial or administrative burden on stakeholders.
Fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the Agency’s budget. If a significant positive balance in the budget, resulting from the provision of the services covered by fees, becomes recurrent, or if a significant negative balance results from the provision of the services covered by fees, the Management Board shall revise the method for calculating the fees in accordance with the procedure set out in paragraph 2.
Where applicable, the Agency shall include a report on the fees levied and their impact on the Agency’s budget as part of the procedure for the presentation of accounts laid down in Article 41.
Article 39
Establishment of the budget
Each year, the Executive Director shall draw up a draft statement of estimates of the Agency’s revenue and expenditure for the following financial year, including the establishment plan, and send it to the Management Board.
The Management Board shall, based on the draft referred to in paragraph 1, adopt a provisional draft statement of estimates of the Agency’s revenue and expenditure for the following financial year.
The provisional draft statement of estimates of the Agency’s revenue and expenditure shall be sent to the Commission by 31 January each year. The Management Board shall send the final draft statement of estimates to the Commission by 31 March.
The Commission shall send the statement of estimates of the Agency’s revenue and expenditure to the budgetary authority together with the draft general budget of the Union.
On the basis of the statement of estimates of the Agency’s revenue and expenditure, the Commission shall enter in the draft general budget of the Union the estimates it considers necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Articles 313 and 314 of the Treaty on the Functioning of the European Union (TFEU).
The budgetary authority shall authorise the appropriations for the contribution to the Agency.
The budgetary authority shall adopt the Agency’s establishment plan.
The Management Board shall adopt the Agency’s budget by a majority of two-thirds of members with the right to vote. The budget shall become final once the general budget of the Union has been definitively adopted. Where necessary, the budget shall be adjusted accordingly.
Delegated Regulation (EU) 2019/715 applies to any building project likely to have significant implications for the budget of the Agency.
Article 40
Implementation of the budget
The Executive Director shall implement the Agency’s budget.
Each year, the Executive Director shall send to the budgetary authority all information relevant for the evaluation procedures set out in Article 51.
Article 41
Presentation of accounts and discharge
By 1 March of the following financial year, the Agency’s accounting officer shall send the provisional accounts to the Commission’s accounting officer and the Court of Auditors.
By 31 March of the following financial year, the Commission’s accounting officer shall send the Agency’s provisional accounts, consolidated with the Commission’s accounts, to the Court of Auditors.
By 31 March of the following financial year, the Agency shall send the report on budgetary and financial management to the European Parliament, the Council and the Court of Auditors.
On receipt of the Court of Auditors’ observations on the Agency’s provisional accounts pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (31), the Executive Director shall draw up the Agency’s final accounts under her or his own responsibility and submit them to the Management Board for an opinion.
The Executive Director shall send the Court of Auditors a reply to its observations by 30 September. The Executive Director shall also send that reply to the Management Board.
The Management Board shall deliver an opinion on the Agency’s final accounts.
The accounting officer shall, by 1 July following each financial year, send the final accounts, together with the Management Board’s opinion, to the European Parliament, the Council, the Commission and the Court of Auditors.
The final accounts shall be published in the Official Journal of the European Union by 15 November of the following year.
The Executive Director shall submit to the European Parliament, at the European Parliament’s request, any information required for the smooth application of the discharge procedure for the financial year in question, in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046.
On a recommendation from the Council acting by a qualified majority, the European Parliament shall, before 15 May of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.
Article 42
Financial rules
The Management Board shall adopt the financial rules applicable to the Agency after consulting the Commission. The financial rules shall not depart from Delegated Regulation (EU) 2019/715 unless such a departure is specifically required for the Agency’s operation and the Commission has given its prior consent.
CHAPTER VII
Staff
Article 43
General provision
The Staff Regulations and the Conditions of Employment of Other Servants and the rules adopted by agreement between the institutions of the Union for giving effect to the Staff Regulations and the Conditions of Employment of Other Servants shall apply to the staff of the Agency.
Where it engages staff from third countries following the conclusion of the agreements referred to in Article 54, the Agency shall comply with the Staff Regulations and the Conditions of Employment of Other Servants.
Article 44
Seconded national experts and other staff
The Agency may make use of seconded national experts or other staff not employed by the Agency. The Staff Regulations and the Conditions of Employment of Other Servants shall not apply to seconded national experts or other staff not employed by the Agency.
The Management Board shall adopt a decision laying down rules on the secondment of national experts to the Agency.
CHAPTER VIII
General and final provisions
Article 45
Privileges and immunities
Protocol No 7 on the Privileges and Immunities of the European Union annexed to the TEU and to the TFEU shall apply to the Agency and its staff.
Article 46
Language arrangements
Council Regulation No 1 (32) shall apply to the Agency.
Article 47
Transparency
Regulation (EC) No 1049/2001 shall apply to documents held by the Agency.
Regulation (EU) 2018/1725 of the European Parliament and of the Council (33) shall apply to the processing of personal data by the Agency.
The Management Board shall, within six months of the date of its first meeting after 2 July 2024, establish measures for the application of Regulation (EU) 2018/1725 by the Agency, including those concerning the appointment of the Agency’s data protection officer. Those measures shall be established after consultation of the European Data Protection Supervisor.
Article 48
Combatting fraud
In order to combat fraud, corruption and other unlawful activities, Regulation (EU, Euratom) No 883/2013 shall apply to the Agency.
The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by OLAF by 1 October 2023 and shall adopt appropriate provisions applicable to all employees of the Agency using the template set out in the Annex to that Agreement.
The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Agency.
OLAF and EPPO may, within the scope of their mandates, carry out investigations, which, with regard to OLAF, may also include on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by the Agency, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (34).
Without prejudice to paragraphs 1 to 4 of this Article, working arrangements and agreements with international organisations and third countries as referred to in Articles 53 and 54, contracts, grant agreements and grant decisions of the Agency shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct the audits and investigations referred to in paragraphs 3 and 4 of this Article, in accordance with their respective competence.
Article 49
Protection of classified and sensitive non-classified information
The Agency shall adopt security rules equivalent to the Commission’s security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444. The security rules of the Agency shall cover, inter alia, provisions for the exchange, processing and storage of such information.
The Agency may only exchange classified information with the relevant authorities of a third country or international organisation or share EUCI with another Union body, office or agency within the framework of administrative arrangements. Administrative arrangements shall be subject to the authorisation of the Management Board after consultation of the Commission. In the absence of an administrative arrangement, any exceptional ad hoc release of EUCI to another Union body, office or agency shall be subject to a decision by the Executive Director after consultation of the Commission.
Article 50
Liability
The Agency’s contractual liability shall be governed by the law applicable to the contract in question.
The Court of Justice of the European Union shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Agency.
In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its staff in the performance of their duties.
The Court of Justice of the European Union shall have jurisdiction in disputes over compensation for damages referred to in paragraph 3.
The personal liability of its staff towards the Agency shall be governed by the Staff Regulations or Conditions of Employment of Other Servants.
Article 51
Evaluation and review
By 3 July 2029, and every five years thereafter, the Commission shall assess the Agency’s performance in relation to its objectives, mandate, tasks and location in accordance with Commission guidelines. Such evaluations shall, in particular, address the possible need to modify the mandate of the Agency and the financial implications of any such modification. In its first evaluation, the Commission shall pay particular attention to the changes to the Agency’s mandate and tasks introduced by this Regulation.
On the occasion of every second evaluation, the Commission shall also assess the results achieved by the Agency having regard to its objectives, mandate and tasks, including whether the continuation of the Agency is justified with regard to those objectives, mandate and tasks.
The Commission shall report to the European Parliament, the Council and the Management Board on the findings of evaluations under this Article. The findings of evaluations shall be made public.
Article 52
Administrative inquiries
The activities of the Agency shall be subject to the inquiries of the European Ombudsman in accordance with Article 228 TFEU.
Article 53
Cooperation with other organisations and bodies
The Agency shall actively seek to cooperate with international organisations and other bodies, in particular Union, governmental and non-governmental bodies, and with technical bodies competent in matters covered by this Regulation, within the framework of working arrangements concluded with such bodies, in accordance with the TFEU and the provisions on the competence of such bodies. Such working arrangements shall not cover the exchange of classified information.
The Management Board shall adopt working arrangements as referred to in paragraph 1 based on drafts submitted by the Executive Director and after the Commission’s prior approval. Where the Commission expresses its disagreement with such working arrangements, the Management Board shall adopt them by a three-fourths majority of members with the right to vote.
The Management Board shall adopt amendments or changes to existing working arrangements which are limited in scope and do not change the overall scope and intention of the working arrangements, or technical working arrangements with other technical bodies, based on drafts submitted by the Executive Director and after informing the Commission.
The Agency shall publish working arrangements entered into pursuant to this Article on its website.
Article 54
Cooperation with third countries
The Agency shall be open to the participation in its work of third countries that have entered into agreements with the Union to that effect.
Under the relevant provisions of the agreements referred to in paragraph 1, arrangements shall be developed specifying, in particular, the nature, extent and manner in which the third countries concerned are to participate in the work of the Agency, including provisions relating to participation in the initiatives undertaken by the Agency, financial contributions and staff.
As regards staff matters, arrangements as referred to in the first subparagraph shall comply with the Staff Regulations.
Article 55
Cooperation with civil society organisations
The Agency shall maintain cooperation with relevant civil society organisations active in the fields covered by this Regulation at national, Union or international level for the purposes of consultation, the exchange of information and the pooling of knowledge through the involvement of those civil society organisations. To that end, the Agency shall designate a single contact point under the authority of the Executive Director to ensure the regular provision of information to civil society organisations on its activities, including by setting up a dedicated webpage or by other relevant means. The Agency shall allow civil society organisations to submit data and information relevant to its activities.
When considering specific topics, the Agency shall, where relevant, conduct dedicated exchanges with civil society organisations with relevant qualifications and experiences on the topic concerned.
Civil society organisations as referred to in paragraphs 1 and 2 shall be registered in the Transparency Register, established by the Interinstitutional Agreement of 20 May 2021 between the European Parliament, the Council of the European Union and the European Commission on a mandatory transparency register (35). The Agency shall make the list of those civil society organisations public.
Article 56
Headquarters Agreement and operating conditions
The necessary arrangements concerning the accommodation to be provided for the Agency in the Member State in which the Agency has its seat, the facilities to be made available by that Member State and the specific rules applicable in that Member State to members of the Management Board, Agency staff, including the Executive Director, and members of their families shall be laid down in a Headquarters Agreement between the Agency and that Member State.
The Member State in which the Agency has its seat shall provide the best possible conditions to ensure the smooth and efficient functioning of the Agency, including multilingual, European-oriented schooling and appropriate transport connections.
Article 57
Legal succession
The Agency shall be the legal successor in respect of all contracts concluded by, liabilities incumbent upon and properties acquired by the EMCDDA.
This Regulation shall not affect the legal force of agreements and arrangements concluded by the EMCDDA before 2 July 2024.
Article 58
Transitional arrangements concerning the Management Board
The Management Board of the EMCDDA shall continue its work and functioning based on Regulation (EC) No 1920/2006 and the rules established thereunder until all representatives of the Management Board are appointed in accordance with Article 23 of this Regulation.
By 1 April 2024, the Member States shall notify the Commission of the names of the persons whom they have appointed as members and alternates of the Management Board in accordance with Article 23.
The Management Board established in accordance with Article 23 shall hold its first meeting by 3 August 2024. On that occasion, the Management Board may adopt its rules of procedures.
Article 59
Transitional arrangements concerning the Executive Director
The Director of the EMCDDA, appointed on the basis of Article 11 of Regulation (EC) No 1920/2006, shall, for the remaining period of her or his term of office, be assigned the responsibilities of Executive Director as provided for in Article 30 of this Regulation. The other conditions of her or his contract shall remain unchanged.
If the term of office of the Director of the EMCDDA ends between 1 July 2023 and 2 July 2024, and if that term has not already been extended under Regulation (EC) No 1920/2006, it shall be extended automatically until 3 July 2025.
Where the Director appointed on the basis of Article 11 of Regulation (EC) No 1920/2006 is unwilling or unable to act in accordance with paragraph 1 of this Article, the Management Board shall designate an interim Executive Director to exercise the duties assigned to the Executive Director for a period not exceeding 18 months, pending the appointment of the Executive Director in accordance with Article 29(2).
Article 60
Transitional arrangements concerning the national focal points
By 1 June 2024, the members of the Management Board shall provide the Agency with the name of the institutions designated as national focal points in accordance with Article 33(1) and the name of the heads of the national focal points. For that purpose, the members of the Management Board may send an e-mail confirming the current status quo.
Article 61
Transitional budgetary provisions
The discharge procedure in respect of the budgets approved on the basis of Article 14 of Regulation (EC) No 1920/2006 shall be carried out in accordance with the rules established by Article 15 of that Regulation.
Article 62
Repeal of Regulation (EC) No 1920/2006
Regulation (EC) No 1920/2006 is repealed with effect from 2 July 2024.References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.
Internal rules and measures adopted by the Management Board on the basis of Regulation (EC) No 1920/2006 shall remain in force after 2 July 2024, unless otherwise decided by the Management Board in the application of this Regulation.
Article 63
Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 2 July 2024.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 June 2023.
For the European Parliament The President R. METSOLA
For the Council The President J. ROSWALL
(1) OJ C 323, 26.8.2022, p. 88.
(2) Position of the European Parliament of 13 June 2023 (not yet published in the Official Journal) and decision of the Council of 27 June 2023.
(3) Council Regulation (EEC) No 302/93 of 8 February 1993 on the establishment of a European Monitoring Centre for Drugs and Drug Addiction (OJ L 36, 12.2.1993, p. 1).
(4) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).
(5) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53).
(6) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(7) 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).
(8) OJ L 136, 31.5.1999, p. 15.
(9) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
(10) 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).
(11) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).
(12) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, p. 1).
(13) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (OJ L 22, 26.1.2005, p. 1).
(14) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, p. 138).
(15) Council Regulation (EC) No 168/2007 of 15 February 2007 establishing a European Union Agency for Fundamental Rights (OJ L 53, 22.2.2007, p. 1).
(16) Regulation (EU) 2015/2219 of the European Parliament and of the Council of 25 November 2015 on the European Union Agency for Law Enforcement Training (CEPOL) and replacing and repealing Council Decision 2005/681/JHA (OJ L 319, 4.12.2015, p. 1).
(17) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(18) 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).
(19) Regulation (EU) 2019/127 of the European Parliament and of the Council of 16 January 2019 establishing the European Foundation for the improvement of living and working conditions (Eurofound), and repealing Council Regulation (EEC) No 1365/75 (OJ L 30, 31.1.2019, p. 74).
(20) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(21) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
(22) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(23) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(24) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(25) 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).
(26) Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority 2021/C 393 I/02 (OJ C 393 I, 29.9.2021, p. 3).
(27) OJ L 56, 4.3.1968, p. 1.
(28) Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 20).
(29) 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).
(30) 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).
(31) 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).
(32) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385).
(33) 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).
(34) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
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