Belgian Medicines Verification Organisation (BeMVO) Articles of association (Statutes) (*)

Transcription

1 Belgian Medicines Verification Organisation (BeMVO) Articles of association (Statutes) (*) (*) This version is a translation from the Dutch/French articles of association. Should there be differences between the original and the translation, the [Dutch/French] version shall prevail.

2 The undersigned eight parties, founding members of the association (in alphabetic order) : 1) ABPH-BVZA, 2) ANGR-NVGV, 3) APB, 4) BACHI, 5) BAPI, 6) FEBELGEN, 7) OPHACO, 8) PHARMA.BE., have reunited today 2017 and by means of this deed declare to incorporate a non-for-profit association, in accordance with Belgian law founded on the Incorporated Associations Act of June 27 th, 1921, amended May 2 nd 2002, allowing non-profit associations, international non-profit associations and foundations to be incorporated of which the articles of association are composed as follows : Preamble : DEFINITIONS 1) BeMVO Belgian Medicines Verification Organisation the national association hereby established by the Constituencies to manage the (supra-) national data repository that will connect ultimately to the European central hub. It will serve as the verification platform to allow the authenticity of medicines anywhere in the supply chain in the EEA to be checked. 2) EEA European Economic Area. 2

3 3) BeMVS - Belgian Medicines Verification System the Belgian national verification repository system (NMVS), in which the data expected for the Belgian (and Grand Duchy of Luxembourg) market will be decommissioned. In this system the operational data will be gathered, updated and reporting activities will be generated. 4) Blue Print Model A set of documents containing: (a) At EU level agreed procedures and policies regarding the implementation of the FMD and related DR from a governance point of view at EU and national level, and (b) The contractual and technical documents, including the system specifications (User Requirements Specifications URS), which is to be used in the relationship with the IT service provider. 5) Constituency (ies) The stakeholder communities representing material users of the System. Their representatives are entitled to full membership of the BeMVO. We have: - Research pharmaceutical companies, - Generic pharmaceutical companies, - Pharmaceutical parallel distributors. - Self-medication pharmaceutical companies, - Pharmaceutical wholesalers - Community pharmacies - Hospital pharmacies 6) Decommissioning - Is the operation of updating the repository system indicating the Unique Identifier is no longer available for delivery (= withdrawal from the system). Decommissioning can have multiple reasons: Dispensing to patient, Recall product, Export out of EU, Repacking Activity, 7) EMVO European Medicines Verification Organisation The international not-for-profit organisation established by stakeholders to manage the European Hub that will connect to a series of national or regional data repositories that will serve as the verification platforms to allow the authenticity of medicines at the point of delivery to the patient in the EEA to be checked. 8) URS User Requirements Specifications The Core documents that are expressly identified as such by EMVO. 9) EMVS European Medicines Verification System The European Operational system or European Hub being used for introducing the manufacturers master data and upload their products into the specific markets and system allowing cross bordering sales and communication between the National Repository systems. System built under the responsibility of managed by the EMVO. 10) Exceptional Event Any indication that gives rise to a suspicion that a given product may be counterfeit or that the System may be attacked or another problem that prevents normal or uninterrupted use of the System. An Exceptional Event would include, by way of illustration, a 3

4 verification failure (because the serial number is not in the System, or is already logged as having been dispensed or decommissioned due to a batch recall for instance), attempted intrusion by an unauthorised party, or any other activity that suggests an attack on the system. Exceptional events will be assigned escalation levels, and related processes will be set out. 11) FMD Falsified Medicines Directive (Directive 2011/62/EU - FMD amending Directive 2001/83/EC), 12) ICT Information and Communication Technology. 13) UI - Unique Identifier or randomised number being uploaded in the NMVS ensuring that a product is coming from a genuine and recognised manufacturing plant. 14) Interoperability Different systems that can interact but have different modi-operandi. 15) LMVO Luxembourg Medicines Verification Organisation. 16) Manufacturers - For the purposes of this articles of association, this term includes both manufacturers and parallel distributors engaged in repackaging to the exclusion of contractors and subcontractors involved in the manufacturing process but not responsible for putting pharmaceutical products on the market. For the avoidance of doubt, a manufacturer engaging contractors or subcontractors to produce on its behalf shall be considered as Manufacturers. 17) Marketing Authorisation Holder(s) or MAH For the purpose of this articles of association this relates to the entities that hold a marketing authorisation for products to be sold on the Belgian Market (and the Luxemburg market for the LMVO) or are the legal representative from the Marketing Authorization Holder. These are the research pharmaceutical companies, generic pharmaceutical companies, pharmaceutical parallel distributors and the self-medication pharmaceutical companies. Or any other company that holds the marketing authorisation for the concerned geography on behalf of one of the previously listed organisations. 18) Master Data Data related to a sales article that is the same for all packs of this article (e.g. name, article number, dose form, dose count, pack type) that shall be registered in the System. 19) Medicines Those products required to bear safety features in accordance with the Directive on Falsified Medicines (FMD), the related Delegated Acts adopted thereunder and all products identified by FAGG/AFMPS - falling within the scope of the Directive. 20) Memorandum of Understanding The memorandum of understanding regarding the creation of BeMVO, signed by the Founding Full Member on [***]. 21) Full Members - Full members are part of a Constituency and have the rights and obligations specified in the present articles of association. 22) Founding Full Members The eight founding members of BeMVO, with special rights as stipulated in art 7.1 and art 15.1 of these Statutes. 4

5 23) Affiliate Members Affiliate members have the rights and obligations specified in the present articles of association. 24) MVS Medicines Verification System The complete verification system: HUB and all National Repositories combined. 25) NCA National Competent Authority, for Belgium FAGG/AFMPS 26) NMVS - The (supra-)national data repository that is connected to the EMVS and having application programming interface allowing the users to connect to the repository system for verification and modification of the product status. 27) Parties The Founding Full Members of this association BeMVO. 28) Payers of the System The FMD indicates that the Manufacturer Authorisation Holders have to cover the investment- and operating costs of the System. For practical reasons the contributions to cover the investment- and operating costs will be borne by the Marketing Authorisation Holders. 29) Pharmacy Pharmacy cover both community and hospital pharmacies, except when specified differently in the text. 30) Stakeholders May be an individual member of one of the Parties or any other user of the system, or any interested body including government departments and agencies 31) System - Collectively, the European Hub ( European Hub ) (European Medicines Verification System) and the national/regional repositories are called the System. 32) Verification A scan of the 2D matrix to check the existence of the pack in the database and to learn the status of the pack. TITLE I. Name Registered Office - Purpose Term Article 1. Name The Founding Full Members agree to establish an association that has the status of a non-profit association and is governed by the Law of June 27 th, 1921 on non-profit organizations, as amended by the Law of May 2 nd The name of the association shall be Belgian Medicines Verification Organization, in short BeMVO. The name may be used in full or in abbreviated form or both and must at all times be preceded or followed by the wording Vereniging zonder winstoogmerk / Association sans but lucrative or its abbreviation ( V.Z.W. / A.S.B.L. ). 5

6 Article 2. Registered office The registered office of the association is established at [address]. [+ gerechtelijk arrondissement]; Further administrative and operational offices may be established at another address by resolution of the General Assembly. Article 3. Purpose and activities The association s primary non-profit purpose is to establish, operate and manage the National Repository System (NMVS) and link with European HUB in compliance with the EMVS and all Blueprint requirements. In view of achieving its purpose, the association will conclude user agreements with the Marketing Authorisation Holders. In addition, the association s non-profit purpose is to cooperate with relevant stakeholders in the implementation of the EU Directive on Falsified Medicines and its Delegated Regulation. The association s purpose may be achieved, without limitation, through: Choosing and contracting one reputable IT service provider (chosen among the 3 preselected IT providers) to set up the NMVS (outsourcing the design and operation of the national system); Adhering to technical standards set up by EMVO to ensure overall quality : applying the set technical standards and ensuring overall quality (on matters such as the interfaces to and from the European Hub, data cleanliness, the availability and responsiveness of the System, the appropriate level of security to be respected, etc.); Implementing defined specifications and standard operating procedures for : (i) (ii) The regular operation of the NMVS, The identification and handling of Exceptional Events as well as the requisite automated filtering algorithms, the elaboration of severity classes and appropriate follow-up procedures in specific scenarios that shall form part of the Foundation Documents. Defining the terms and conditions governing access to the NMVS that shall be objective and transparent and open to any party duly authorised to operate in the legal supply chain; Managing the IT, contractual and human interfaces between the EMVS and BeMVS; 6

7 Providing regular activity reports to members on issues such as NMVS functioning and performance, and generating statistical reports for the purposes of aiding communications on the functioning of the NMVS; Invoicing and collecting membership fees and any other monies due; Liaising with the relevant national authorities with access and supervisory rights on the practical implementation of the NMVS to facilitate product recalls or other patient safety issues; and Member State use of the data within the NMVS pursuant to the EU Directive on Falsified Medicines; Providing services to stakeholders in the fulfilment of mutually agreed bilateral or multiparty data access as agreed on a case-by-case basis; All activities described in art 37 of the Delegated Regulations; Organise appropriate operational / commercial activities in line with all legislation and after agreement of the concerned associations on a case-by-case basis; and if appropriate - create a company (ies) for that purpose or participate as a shareholder in a company (ies); The association can carry out all activities that directly or indirectly relate to the realisation of its purpose including, but not limited to buy, sell, rent, take possession of all real estate and installations, take a mortgage on such goods, take out loans, employ relevant personnel, engage in legal proceedings and hire contractors as required. The association can choose to outsource activities with regard to the above responsibilities to the EMVO or IT service provider under a service level agreement. Article 4. Term The association has been established for an unlimited term. TITLE II. Members Constituencies The Parties are opting for the approach of Constituencies, as it has been agreed on a European level, in order to obtain a fair and balanced division in the voting rights between groups of stakeholders. 7

8 The Constituencies, representing material users of the EMVS, that are obliged to have a Full Member representing them in BeMVO are: - The research pharmaceutical companies, - The generic pharmaceutical companies, - The pharmaceutical parallel distributors. The Constituencies that have the choice to be represented by a Full Member in BeMVO are: - The self-medication pharmaceutical companies, - The full-line pharmaceutical wholesalers, - The community pharmacies, - The hospital pharmacies. Members Article 5. Types of members 5.1. The association is composed of the following types of members: Full Members and nonvoting Affiliate Members Full Membership Representative federations are entitled to full membership of the BeMVO. Full Members are the 8 founding members, representing the seven Constituencies (in alphabetic order) : - ABPH-BVZA, representing the Constituency hospital pharmacies, - ANGR-NVGV, representing the Constituency full-line pharmaceutical wholesalers, - APB, together with APHACO, representing the Constituency community pharmacies, - BACHI, representing the Constituency self-medication pharmaceutical companies, - BAPI, representing the Constituency pharmaceutical parallel distributors, - FEBELGEN, representing the Constituency generic pharmaceutical companies, - OPHACO, together with APB, representing the Constituency community pharmacies, - PHARMA.BE, representing the Constituency research pharmaceutical companies. and any other association that is admitted as such at a later time. Although many Full Members cover activities covered by different Constituencies, Full Members are not allowed to represent more than one Constituency and are not allowed to change the Constituency they belong to. 8

9 Each Full Member decides freely about the appointment of the physical persons that will represent the Full Member in the General Assembly Affiliate Membership Affiliate Members are parties admitted as such The members (full and affiliate) do not incur any personal liability for commitments of the association The association is composed of a minimum of three Full Members. Article 6. Rights and Obligations 6.1. Full Members have the following rights and obligations: - The right to participate in and vote at the General Assembly meetings in accordance with these Statutes; - The right to be appointed as Director or Board Advisor in accordance with these Statutes and in such capacity participate in the Board of Directors (as Director or Board Advisor); - The right to participate in working groups and task forces as may be established from time to time; - The right to appoint representative members of their organization or of affiliate members to participate in working groups and task forces, on an as needed basis; - The right to review and add specific items in the planned periodic security audits; - The right to request an independent audit of NMVS security and performance provided such audits are carried out only at reasonable intervals and at the expense of the requesting member; - The obligation to pay a yearly membership fee; - The obligation to act in compliance with the Statutes; and - Any other right or obligation that may be decided by the General Assembly or the Board of Directors in accordance with applicable laws and regulations. These rights and obligations of Full Members which are part of a Constituency represented by more than one Full Member are limited as set out in Articles 12, 13 and 15. 9

10 6.2. Affiliate Members have the following rights and obligations: - The right to receive notice of all General Assembly's meetings and the right to attend such meetings in a non-voting observer capacity only; - The right to be consulted on the activities of the NMVO as may be decided from time to time by the General Assembly; - The right to participate in working groups and task forces as may be established from time to time decision to be taken by the Board of Directors; - The obligation to pay a yearly affiliate membership fee as may be foreseen pursuant to Article 9 below; - The obligation to act in compliance with the Statutes; and - Any other right or obligation set out in the internal regulations or that may be decided by the General Assembly or the Board of Directors. Such rights and obligations may differ for each category of Affiliate Membership. Other than as set out below, the rights and obligations of the Affiliate Members shall be set out in the internal regulations or shall be further determined by the General Assembly or Board of Directors. Article 7. Admission 7.1. Admission of new Full Members Admission of new Full Member is open to national associations that cumulatively fulfil all the following conditions: - Falling within any Constituency that is material user of the NMVS; - Proving a stable and significant representation within the activities of the targeted Constituency; - Adhering the statutes of the BeMVO; - Adhering the admission rules set out by the Founding Full Members (see here after); and - Being proposed as Full Member of BeMVO by one of the Constituencies. 10

11 The Founding Full Members of each Constituency develop more specific rules and procedures for admission of new Full Members within their Constituency, it being understood that the General Assembly will decide on the admission of new Full Members. If a Full Member is admitted by the General Assembly, that Full Member will belong to the Constituency, which had submitted a final proposal for approval of such Full Member to the General Assembly. The Constituency submits the final proposal for new Full Members within their Constituency to the General Assembly for approval. The General Assembly will decide, at its own discretion, on the admission of new Full Members Admission of Affiliates Members Affiliate Membership is open towards: - Associations representing any Constituency of users that qualify for but have chosen not to elect for full Membership; - Non-profit or for-profit associations of stakeholders representing users or potential users of the NMVS for authentication purposes; - Government bodies active in domain of FMD; - Individual manufacturers and marketing authorisation holders using the NMVS for authentication purpose; and - Wholesalers and persons authorised or entitled to supply medical products to the public. Candidate new Affiliate Members submit their request for Affiliate Membership towards the Board of Directors of the BeMVO. The Board of Directors will take a decision on admission at its own discretion after consultation and agreement of the related Constituency. Article 8. Procedure - Resignation - Exclusion Every member (Full Member and Affiliate Member) has the right to terminate its membership effective at the end of each fiscal year upon at least six months' prior written notice to the Board of Directors. In case of forced or voluntary dissolution, or insolvency, bankruptcy, cessation of operations and similar events of a Full Member or an Affiliate Member, membership shall be deemed to be terminated upon notification by the Chair of the Board of Directors, or his delegate to that member. 11

12 The violation of any term or condition set forth in the present Statutes, or in the internal regulations, if any, can result in the loss of membership of the association. In such event, a Full Member or an Affiliate Member can at any time be excluded by resolution of the General Assembly requiring a majority vote of two thirds of the votes cast (taking into account that the Full Members representing a Constituency shall together have one vote in accordance with article 12). The exclusion of the member must be included in the agenda of that meeting, and the relevant member shall be given the opportunity to state its defense before the relevant meeting before the resolution is voted upon. Any decision to exclude has immediate effect, unless otherwise resolved by the General Assembly. Should any Full Member, once admitted, fail to satisfy the full membership criteria (set out in these Statutes or set out by the governance rules within the concerned Constituency) as determined by a resolution of the Board of Directors, it shall be entitled to maintain full membership until the end of the fiscal year. If the criteria remain unfulfilled at the end of the fiscal year, the Full Member concerned shall cease to be a Full Member unless the relevant Constituency would no longer be represented by a Full Member and subject to a decision of the General Assembly requiring a majority of two thirds of the votes cast in its sole discretion (taking into account that the Full Members representing a Constituency shall together have one vote in accordance with article 12). Any disputes as to whether the membership criteria continue to be fulfilled shall be adjudicated on by an independent third party to be appointed by the Board of Directors. Resigning or excluded members, and their legal successors, do not have any right with regard to any of the assets of the association and cannot, under any circumstance, claim any reimbursement of any nature whatsoever. Article 9. Membership fees 9.1. Membership Fees Full Members Each Full Member will be liable to pay a fixed annual fee to contribute to the governance costs of the BeVMO. The membership fees for Full Members are determined on the level of the Constituencies, whereby each Constituency (represented through its Full Member(s)) will have to pay an equal annual fee. In the event a Constituency is represented by more than one Full Member, the total fee payable by the Full Members of such Constituency will be divided equally among the Full Members of such Constituency unless those Full Members agree otherwise. The fee level can be revised by the General Assembly on a recommendation of the Board of Directors, but shall not exceed ,00 Euro per year. 12

13 Each Full Member shall be liable vis-à-vis the BeMVO for the payment of its own share of the total fee payable by the Constituency and, for the avoidance of doubt, shall not be jointly liable for the share of the total fee payable by any other Full Member of the same Constituency. Any payments shall be made not later than 60 days of a request for payment. Failure to pay the annual fee in full in a timely manner shall automatically trigger a suspension of voting rights of the Full Member and/or its Constituency until such time as fees are settled in full. Membership fees cannot be recovered in case of a voluntary or forced termination of the membership or upon the exclusion of a member from the association Membership Fees Affiliate Members The annual membership fee for Affiliate Members is equal to all Affiliate Members and is set by the General Assembly on a recommendation of the Board of Directors, but shall not exceed 1.000,00 Euro. Any payments shall be made not later than 60 days of a request for payment. Failure to pay the annual fee in full in a timely manner shall automatically trigger a suspension of all rights of the Affiliate Member until such time as fees are settled in full. Membership fees cannot be recovered in case of a voluntary or forced termination of the membership or upon the exclusion of a member from the association. TITLE III. The General Assembly Article 10. Composition - Powers The General Assembly is composed of all Full Members. The Affiliate Members and one representative appointed by the competent authority being the Federaal Agentschap voor Geneesmiddelen en gezondheidsproducten (FAGG AFMPS) can attend such meetings in an observer capacity, without voting right. The Board of Directors may agree to admit other external observers to the General Assembly The General Assembly is the leading body of BeMVO. All powers not specifically attributed to the General Assembly by the Statutes or the Incorporated Associations Act of June 27 th, 1921, will belong to the Board of Directors. It shall review annually, as an agenda item and based on a report of the Board of Directors, the adequacy of the BeMVO structure, and resources available, in light of its objectives. 13

14 The General Assembly has the exclusive power to decide on the following matters: - Approval of the annual budget (including the annual membership fees) and the annual accounts; - Approval of allocation of services fees to be charged to the MAH for the use of the system on recommendations of the Board of Directors - The determination of the membership fees; - All changes to the agreed principles on (authentication) data access; - Decide on change of IT provider; - Amendment of the Statutes; - Appointment and dismissal of a Chair, a Vice Chair, a Treasurer and the appointment of a Managing Director or General Manager on proposal of the Board of Directors; - Appointment and dismissal of new members of the Board of Directors as well as Board Advisors, without prejudice to article 15.6; - Grant of discharge to the members of the Board of Directors; - Appointment and dismissal of and granting of discharge to a Statutory Auditor, if any; - The admission of new Full Members; - The exclusion of Full Members and of Affiliate Members in accordance with the foreseen procedures; and - The timing and manner of effecting the dissolution and liquidation of the BeMVO. The General Assembly can delegate certain decisions to the Board of Directors, with the exception of (i) the decisions which are subject to veto rights pursuant to Article and (ii) the decisions which cannot be delegated according to the Incorporated Associations Act of June 27 th, Article 11. Meetings Convocations The General Assembly shall meet in ordinary session once a year. Special or Extraordinary General Assemblies can be convened by the Board of Directors whenever the interest of BeMVO so requires or at the request of a minimum of two Full Members who represent different Constituencies or at the request of at least 20% of the Full Members. 14

15 As an alternative to the Extraordinary General Assemblies, the Full Members may unanimously adopt written resolutions pursuant to Article The convocation notice shall include the agenda, date, time and place of the meeting. The convocation notice must be sent by letter, or any other communication device which produces a written document, at least thirty days prior to the meeting, unless in case of urgency which shall be set out in writing by the Chair, in which case the notice period is reduced to eight days The meetings are held at the registered office of the association or at any other place indicated in the convocation notice They are chaired by the Chair of the Board of Directors or, in his absence, by the Vice Chair, or in his absence, by the longest serving Director present. Article 12. Voting rights Representation Subject to the qualification in the following paragraph, each Full Member shall have one vote in the General Assembly In the event that one Constituency is represented by more than one Full Member, the Full Members will be entitled to only one vote per Constituency. Those Full Members shall consult jointly prior to a General Assembly meeting on the voting behavior for such Constituency. Absent a written agreement between all Full Members of a Constituency as to how they will exercise their vote (i.e. either a precise way of voting for a topic on the agenda, either a proxy to the Full Member that will exercise the vote to decide during the meeting on the way the voting right will be exercised for a certain topic) and which Full Member of the Constituency will exercise their vote at the General Assembly, the vote of the Full Members representing such Constituency will be suspended and the Full Members representing such Constituency shall not be able to vote In order to vote at the General Assembly meetings, each Full Members must, at least five business days prior to the meeting, or, in case the meeting is called with a notice period of eight days, at least two days prior to the meeting, inform the Chair of the Board of Directors, in writing (including ), of its intention to attend the meeting indicating the name and capacity of the person authorized to vote on behalf of that Full Member. Every Full Member entitled to vote has the right to grant to any individual authorized to represent another Full Member, a proxy to represent such Member at the occasion of a meeting of the General Assembly and to vote on its behalf. A proxy holder can hold only one proxy. Article 13. Deliberations The General Assembly meeting can validly resolve only (i) upon items included in the agenda, or (ii) upon items that are not included in the agenda, provided that all Full Members are 15

16 present and unanimously resolve thereon. In this respect, unanimity requires that no opposition from a Full Member is recorded in the minutes of the meeting of the General Assembly Attendance Quorum. The General Assembly can validly deliberate and resolve if Full Members representing at least two-thirds of the Constituencies are present at the meeting or are represented by written proxy at the meeting. If this attendance quorum is not met at a first meeting, a second meeting with the same agenda can be called for which no attendance quorum shall apply, without prejudice to the special conditions stipulated in article 25 for amendments to the Statutes. If all Full Members are present or represented at the meeting, the General Assembly's meeting shall be deemed validly convened and no further proof of the duly convening of the meeting shall be required Majorities Decisions at General Assembly meetings shall be adopted by at least two-thirds of the votes cast, except where law requires a higher majority, or unless any Full Member holding a voting right or, as the case might be, two or more Full Members holding together one voting right in accordance with article 12.2, validly exercises any veto right in any of the circumstances listed below. Failure to vote, invalid votes and blank votes shall be considered as an abstention. Abstentions are not taken into account for the calculation of the majorities. The Full Members can unanimously adopt written resolutions in respect of all matters that fall within the powers of the General Assembly meeting, with the exception of the approval of the annual accounts. Resolutions adopted pursuant to this procedure shall be sent to each of the Affiliate Members within ten working days from their adoption Veto rights Subject to the qualifications below in this section 13.4 each Full Member shall have the following veto rights in relation to the General Assembly's decision-making powers after due consultation and debate and provided the exercise of such rights results in an outcome that is compliant with applicable laws : Full Members representing individually or together with one or more other Full Members, one of the four Constituencies representing the MAH paying the development and operations costs of the NMVS will have a veto right in case a decision at stake has an impact on the combined contributions of the stakeholders of that Constituency of more than Euro. The Board of Directors will do the calculation of the above impact. Full Members representing individually or together with one or more other Full Members a Constituency have a veto right in the General Assembly in the following domains : - Membership fees are raised by more than 15% 16

17 - In case of changes to the agreed principles on data access and management, provided these latter changes concern the respective Member s and stakeholders own data and are not against the legal rights of public authority to have access to data. In the event that one Constituency is represented by more than one Full Member, the veto right by the Full Members of such Constituency can only be exercised by a person duly authorized by all Full Members of such Constituency. The Full Members of a Constituency shall consult jointly on whether the veto right of the relevant Constituency shall be exercised with respect to a matter. Absent a written agreement by all Full Members of a Constituency as to how they will exercise their veto right (i.e. either a precise way of using the veto right for a topic on the agenda, either a proxy to the Full Member that will exercise the vote to decide during the meeting on the way the veto right will be exercised for a certain topic), the veto right of the Full Members representing such Constituency will be suspended and the Full Members of such Constituency shall not be able to use their veto right. Article 14. Minutes of the General Assembly meeting The resolutions of the General Assembly meeting must be recorded in minutes. The minutes must be signed by the Chair and the secretary of the meeting The minutes and their annexes are kept in a special register at the registered office of the association, in their original material form, or in a secured electronic form provided that durability, legibility, integrity and truthful reproduction are guaranteed Full Members and Affiliate Members can consult the minutes at the registered office. Unless otherwise determined by law or by the Board of Directors, copies or excerpts of the minutes can be signed by the Chair of the Board of Directors or by two Directors. TITLE IV. Management BOARD OF DIRECTORS Article 15. Composition Subject to the qualification in the following paragraph, each Founding Full Member shall have the right to obtain the appointment of one Director to the Board of Directors from among the candidates it proposes. 17

18 15.2. In the event that a Constituency is represented by more than one Founding Full Member, the Founding Full Members of such Constituency shall collectively have the right to obtain the appointment of one Director in the Board of Directors and one Board Advisor. The Founding Full Members of that Constituency will decide on the governance rules within the Constituency e.g. regarding the process to obtain the appointment of one Director and one Board Advisor The Board Advisor can participate in the meetings of the Board of Directors with an advisory function only The General Assembly has to appoint the Board Advisor Non-founding Full Members can obtain the appointment of a Board Observer. Such Board Observers can participate in the meetings of the Board of Directors with an advisory function only The Founding Full Members of a Constituency can, by unanimity, decide to propose to the General Assembly to appoint a Director in the Board of Directors representing a non-founding Full Member The national competent authority has the right to delegate a representative to participate as a Board Observer The mandate of the Board of Directors members and the Board Advisors shall be two years. The mandates are renewable unlimited times for subsequent periods of two years The mandate of the members of the Board of Directors is not remunerated. Attendance fees are not foreseen, nor the reimbursement of costs If a legal entity is appointed as Director, it must appoint a representative physical person who shall exercise the mandate as Director of BeMVO The Directors do not, in the framework of their function, contract any personal obligation and are not responsible, except for the performance of their mandate. Article 16. Board of Directors: End of mandate - Vacancy The mandate of a Director ends by: Voluntary resignation in writing to the Board of Directors, whereby the resigning Director shall remain in office until the next meeting of the General Assembly, where a decision on replacement shall be taken; Expiration of the term of the mandate; Death; 18

19 End of the contractual or employment relationship between the Director and the Full Member the Director represents; Forced or voluntary dissolution, or insolvency, bankruptcy and similar events of the Director s legal entity; or Dismissal prior to the expiry of his/her term, by the General Assembly s meeting Each Director, Board Advisor or Board Observer can be dismissed by the General Assembly at any time without cause When a director resigns or when the mandate of a director becomes vacant, a meeting of the General Assembly should be called within [two months], whereby the Founding Full Members of the relevant Constituency upon which proposal the director was appointed, have the right to propose candidates to the General Assembly to fill the vacancy. The newly appointed Director shall after appointment of the General Assembly - continue the term of the mandate of the director he replaces. Article 17. Board of Directors: The Chair The Chair of the Board of Directors is attributed to one of the Directors of the Board representing one of the Marketing Authorisation Holder Constituencies. Article 18. Powers of the Board of Directors Delegation - Daily management The Board of Directors shall ensure that the BeMVO operates in compliance will all relevant laws and the Statutes. The Board of Directors shall have all powers except those reserved to the General Assembly to implement overall policies, objectives, procedures, methods and actions of the BeMVO that shall include the following : To propose to the General Assembly a Chair, a Vice Chair and a Treasurer from amongst the Directors serving on the Board; To ensure minutes are kept of all Board of Directors' meetings and to communicate decisions to all members; To prepare a budget and the annual accounts, to open a bank account, and to take any necessary measures to ensure the proper financial management of the BeMVO. To decide on the use of the data for purposes other than verification activities, in line with the procedure set out in paragraph 93 of the Memorandum of Understanding; To make recommendations to the General Assembly as to the service fees to be charged to Marketing Authorisation Holders for the use of the National Systems; 19

20 To delegate, in writing and under its responsibility, the daily management to a Director ("Managing Director"), or to a third party who is not a Director ("General Manager") that has been appointed by the General Assembly; To delegate, in writing and under its responsibility, part of its powers to one or more Directors of the BeMVO or to outsource clearly defined projects to third parties; To propose, as deemed necessary, Internal Regulations compatible with the Statutes, specifying the provisions of the Statutes and fixing the practical modalities to ensure the proper functioning and financing of BeMVO; To supervise implementation and to monitor on a continuous basis BeMVO s performance issues, incident management, operational changes, configuration management, and data access security and to report on such issues to the General Assemby. These tasks shall be executed in cooperation with the EMVO as appropriate in case the NMVS has decided to task the EMVO with the technical running of the system; To propose policies to the General Assembly in relation to the implementation and development of the BeMVS; To make written and duly reasoned recommendations to the General Assembly as to the admission of new Full Members and the termination of membership as it considers appropriate; To decide on the admission of Affiliates Members. The Board of Directors has the power to establish and dissolve any committees and to determine their composition, remuneration and work method. The documents relating to the appointment and the dismissal/resignation of the Directors and, as the case may be, the persons authorized to represent the association, are filed and published in accordance with the applicable legal provisions. Article 19. Meetings of the Board of Directors The BeMVO shall be managed by a Board of Directors that shall meet at least three times a year. An extraordinary session of the Board of Directors shall be convened if at least two of the Directors request such a meeting The convocation notice shall include the agenda, date, time and place of the meeting. The convocation notice must be sent by letter, or any other communication device which produces a written document, at least 15 days prior to the meeting, unless in case of urgency which shall be motivated, in which case the notice period is reduced to seven days. Such convocation notice shall also be sent to the Board Observers. 20

21 19.3. The meetings are held at the registered office of the association or at any other place indicated in the convocation notice The Chair, or, in the absence of the Chair, the Vice Chair, if any, or in the absence of the Vice Chair, if any, the longest serving Director present and representing the industry, shall chair the meetings of the Board of Directors. If all Directors are present or represented at the meeting, the Board of Directors' meeting shall be deemed validly convened and no further proof of the duly convening of the meeting shall be required. Article 20. Deliberations of the Board of Directors The Board of Directors shall validly meet and deliberate when at least 50 % + 1 of the Directors are present in person or represented by written proxy. If this attendance quorum is not met at a first meeting, a second meeting with the same agenda can be called for which no attendance quorum shall apply Each Director of the Board of Directors has one vote All decisions shall require a 2/3 majority of the votes of the Directors present at a Board of Directors' meeting or validly represented. Failure to vote shall be considered as an abstention. Every Director has the right to grant any other Director, by a document carrying his signature, a proxy to represent such Director at the occasion of a meeting of the Board of Directors and to vote on its behalf. A proxy holder can hold only one proxy The Directors can, by unanimous vote, adopt written resolutions in respect of all resolutions that fall within the powers of the Board of Directors, with the exception of the approval of the annual accounts that will be submitted to the General Assembly. The Chair shall promptly afterwards send a copy to the Observers. Article 21. Minutes of the meeting of the Board of Directors All resolutions of the Board of Directors must be recorded in minutes. The minutes must be signed by the Chair or by two Directors and formally approved at the next meeting The minutes and their annexes are kept in a special register at the registered office of the association, in their original material form, or in a secured electronic form provided that durability, legibility, integrity and truthful reproduction are guaranteed Directors, Board Advisors and Board Observers can consult the minutes at the registered office or receive a copy. 21

22 Excerpts can be delivered to third parties who can justify a legitimate interest thereto. Unless otherwise determined by law or by the Board of Directors, copies or excerpts of the minutes, must be signed by the Chair of the Board of Directors or by two Directors. Article 22. Representation and Officers The BeMVO shall have as officers a Chair, Vice Chair and Treasurer The Chair shall ensure that the Board of Directors is effective in its tasks of setting and implementing strategy. He will preside over meetings of the Board of Directors and the General Assembly and carry out the policies and instructions of both. The main responsibilities of the Chair shall include : - To convene all meetings of the General Assembly and the Board of Directors, - To carry out the policies decided by the Board of Directors and to propose to the Board of Directors appropriate plans and manage their execution once approved, - To establish and maintain proper communications with all members, - To cooperate with EMVO representatives with a view to ensuring the functioning and governance of the system, - To ensure appropriate communication with the NMVS users, - To represent the BeMVO and its members to third parties, including governmental and regulatory bodies. In case of absence of the Chair, the Vice Chair shall assume the functions of the Chair and shall execute the powers of the Chair Additionally one Managing Director or General Manager can be appointed. The Managing Director or General Manager, if any, shall be entrusted with the daily management of the BeMVO. Such daily management covers (i) all matters that arise in the BeMVO's ordinary course of business or (ii) that need to be dealt with in an expedient manner so as not to block the day-today operations of the BeMVO. The Board may specify the matters that belong to daily management. The Managing Director or General Manager will provide the Board in due time with all information necessary for the Board to carry out its duties and will be responsible and accountable to the Board for the discharge of their responsibilities. 22

23 22.4. Representation Notwithstanding the general power of the Board of Directors as a collegial body, the association is validly represented in legal proceedings and vis-à-vis third parties, including, but not limited to, public officers (such as the mortgage clerk) by either : - A special ad hoc proxy holder appointed by the Board of Directors; - The Chair of the Board of Directors, acting singly; - Two Directors, of which at least one Director from the industry stakeholders, acting jointly; - The General Manager(s) or Managing Director(s), acting singly, within the limits of the delegated daily management powers. No further justification or prior decision of the Board of Directors shall be required in this respect. TITLE V. Fiscal year annual accounts budget - audit Article 23. Fiscal year annual accounts The accounting year starts on January 1 and ends on December 31 of each year. Each year, the Board of Directors shall prepare the annual accounts of the fiscal year that ended in accordance with applicable law, as well as the budget for the following fiscal year. These are submitted to the General Assembly's meeting for approval. The approved annual accounts must be deposited in the file of the association kept by the clerk s office of the competent Commercial Court. The accounting shall be done in accordance with applicable laws and regulations. Article 24. Audit statutory auditor If so required pursuant to applicable law, an annual audit of the financial situation of the association, of the annual accounts, and of the compliance with applicable law and the present Statutes of the operations to be included in the annual accounts, shall be entrusted to a statutory auditor, to be appointed by the General Assembly's meeting. The auditors are appointed for a renewable term of three years. 23

24 TITLE VI. Amendments to the Statutes - Dissolution Article 25. Special conditions for amendments to the Statutes The Statutes can be amended at any time by resolution of the General Assembly's meeting The General Assembly's meeting cannot validly resolve upon a modification of the Statutes unless this item was included in the convocation notice and provided that Full Members representing at least two thirds of the Constituencies are present or represented by written proxy at the meeting. If this attendance quorum has not been reached, a second meeting shall be convened, with the same agenda and under the same conditions as the first meeting, which shall validly deliberate provided that Full Members representing at least half of the Constituencies are present or represented. The second meeting cannot be held within a period of fifteen days after the first meeting or later than six weeks after the first meeting Without prejudice to article 25.4 and article 25.5, any amendment of the Statutes requires a majority of at least two-thirds of the votes cast, except where law requires a higher majority, or unless any Full Member holding a voting right or, as the case might be, two or more Full Members holding together one voting right in accordance with article 12.2, validly exercise their veto right. An abstention is not taken into account when calculating the majority concerned Any amendment of the veto rights in Article 13.4 shall require (i) a unanimous vote of the Full Members present or represented in relation to the veto rights conferred on all Full Members representing a Constituency, and (ii) a unanimous vote of the Full Members present or represented, representing the four Constituencies representing the Marketing Authorisation Holders in relation to the veto right conferred only on them An amendment of the purpose of the association requires a majority of at least four-fifths of the votes cast, unless any Full Member holding a voting right or, as the case might be, two or more Full Members holding together one voting right in accordance with article 12.2, validly exercise their veto right. An abstention is not taken into account when calculating the majority concerned Any amendment of the purpose of the association immediately enters into force except when required otherwise by national law. Article 26. Dissolution - Liquidation - Allocation of the assets Without prejudice of the Incorporated Associations Act of June 27 th, 1921, amended May 2 nd 2002, the Association can be dissolved at any time by resolution of the General Assembly's meeting, adopted by a majority of at least four-fifths of the votes cast. 24