Statutes Final version MVO Portugal Associação Portuguesa de Verificação de Medicamentos (Portuguese Medicines Verification Association) CHAPTER I Corporate name, head office and goal Article 1 Corporate name, duration and scope MVO Portugal Associação Portuguesa de Verificação de Medicamentos, which in short may be referred to as Association, is a non-profit, limited duration association, incorporated and ruled in compliance with the Portuguese law, and pursues its activity all over the national territory. Article 2 Head office The Association has its head office in Avenida Dom Vasco da Gama, no. 34, parish of Bélem, in Lisbon municipality, and may, however, set up delegations or other forms of representation in any other location of the national territory. Article 3 Goal 1. The goal of the Association is: a) The development and management of a national system of repository of information (hereinafter referred to as System ) on the safety devices contained in medicinal products which enable to check their authenticity and identify them according to the provisions of subparagraph e) of no. 2 of article 54-A of Directive no. 2001/83/CE, of the European Parliament and the Council, of November 6 th, 2001 as amended by Directive no. 2011/62/UE, of the European Parliament and the Council, of June 8 th, 2011 (hereinafter referred to as Directive ) and the Delegated Regulation (EU) no. 2016/161, of the Commission of October 2 nd, 2015 1
(hereinafter referred to as Delegated Regulation ), and the other legal tools and legal texts which govern or will govern the operation of the System; b) To manage the interoperability between the System and the European system (hereinafter referred to as Central European Hub ), currently managed by the European Medicines Verification Organisation, A.S.B.L. (hereinafter referred to as EMVO ), as well as the contractual interaction between the two bodies; c) To cooperate with other bodies for the implementation of the Directive, the Delegate Regulation or any other delegated acts whish are to be published; d) Any other activity directly or indirectly related to the provisions of the previous subparagraphs. Article 4 Field of activity 1. During its activity, the Association should, namely: a) Apply the requirements set out by EMVO and ensure the general quality of the System s operation, namely data clean up, the System s availability and responsiveness and the appropriate security level; b) Set out the terms and conditions of access to the System, which should be practical and transparent; c) Set out and implement the necessary requirements and procedures for the regular operation of the System, including the identification and settlement of any irregularities; d) Hire one or more accredited providers of Information and Communication Technology Services (hereinafter referred to as ICT Services ) to install and manage the System; e) Hire the required employees and suppliers to pursue its goal; f) Prepare and manage the agreements to use the System and set out the provisions regarding remunerations and methods of payment, taking into account article 31 of the Delegated Regulation and what has been agreed among the Permanent Members; g) Guarantee the communication with the national regulatory authorities on the use of the System to facilitate the procedures of recalling medicinal products and manage other issues regarding the patients safety; 2
h) Prepare and provide the members and the Advisory Board with regular activity reports and statistical reports on the System s operation and performance; i) Carry out periodical strategic assessments to the System to guarantee this progresses along time, for the patients safety interest and in line with the evolution of the health care infrastructure in Portugal and in Europe; j) To invoice and to collect fees, and other participation fees and costs, according to the Directive and the Delegated Regulation and any other amounts owed by the members in terms of the statutes. 1. The Association is forbidden to enter any trade business. Article 5 National information repository system 1. The System consists of a platform to check the authenticity of the medicinal products at any stage of the national supply chain. 2. The structure and operation of the System should comply with the provisions of the Directive and the Delegated Regulation. 3. The System aims exclusively for preventing and discovering falsifications and not to access the member s personal data and any additional use of transactional data should be the subject of a specific agreement among the stakeholders. 4. The contracts signed with ICT Service providers, as well as the respective amendments should safeguard the operation efficiency of each one of the members. CHAPTER II Of the members Article 6 Categories and admittance 1. The Association has the following categories of members: a) Permanent Members; b) Associate Members. 2. Permanent membership of the Association shall be open to the sectorial organizations of corporate bodies with head office in Portugal, which are holders of a Marketing Authorization (hereinafter referred to as MA ), and or which are engaged in 3
production, importation, exportation, wholesaling distribution or dispensing of medicinal products to the public, as well as, individually, the mentioned corporate bodies. 3. Associate membership of the Association shall be open to above mentioned sectorial organizations and corporate bodies which are not Permanent Members, including those which are not part of sectorial organizations, the hospitals, natural persons which are manufacturers or MA holders and other bodies representing the users or potential users of the System for the purposes of verifying the authenticity. 4. The corporate bodies mentioned in the previous number which are associates of sectorial organizations and Permanent members of this Association have the status of Associate Members. 5. The admission of members depends on the decision of the General-Meeting, by means of a proposal of the Board of Directors, after a written application addressed to the Board in which they show the compliance with the requirements mentioned in numbers 2 and 3 as well as their acceptance and adherence to these Statutes. 6. Regarding the admission of Permanent Members, the proposal mentioned in the previous number specifies the group where the Permanent Member candidate will be included according to the provisions of the next article. 7. The members are represented in the Association by the person or persons appointed by them. Article 7 Groups of Permanent Members 1. The Permanent Members which engage in the same main activity constitute a Group for the purposes of voting in General-Meeting, of proposing their candidates for the Board of Directors and of fees payment. The existing groups are exclusively the following: a) Research-based Pharmaceutical Industry; b) Generic and biosimilars Pharmaceutical Industry; c) Wholesale distributors; d) Pharmacies; e) Parallel importers and distributors. 2. The voting and, in general, the definitions of the Group s position are established, by majority, according to the following: 4
a) Research-based Pharmaceutical Industry: each Permanent Member is entitled to a number of votes corresponding to the respective market share, calculated [in value or volume]; b) Generic and biosimilars Pharmaceutical Industry: each Permanent Member is entitled to a number of votes corresponding to the respective market share, calculated [in value or volume]; c) Wholesale distributors: [market share]; d) Pharmacies: each Permanent Member is entitled to a number of votes corresponding to the number of their associated pharmacies; e) Parallel importers and distributors: each Permanent Member is entitled to a number of votes corresponding to the respective market share, calculated [in value or volume]. Article 8 Rights and obligations of the members 1. Permanent Members have the following rights: a) To take part and vote in General-Meetings; b) To take part and vote in set up task groups; c) To elect and be elected to the offices of the Association; d) To call for extraordinary General-Meetings according to n o. 2 of article 16. e) To make suggestions deemed convenient to pursue the statutory purposes; f) To ask for independent audits regarding the safety and performance of the System, provided they take place with reasonable periodicity and are financially borne by the applicant member; g) Any others [rights] which will be decided by the General-Meeting or by the Board of Directors. 2. Permanent Members have the following obligations: a) To timely pay the annual fee and other contributions set out by the General- Meeting; b) To exercise the offices of the Association, they have been elected or appointed for; c) To attend the General-Meetings and other meetings they are summoned to; d) To comply with what is provided in these Statutes, the Association Regulations and the decisions of the governing bodies; 5
e) To comply with the obligations to be imposed following the decisions of the General-Meeting or the Board. 3. The Associate Members have the following rights: a) To attend the General-Meetings as observers; b) To be consulted about the activities of the Association, as decided by the General- Meeting; c) Any other which are to be decided by the General-Meeting or the Board. 4. The Associate Members have the following obligations: a) To timely pay the annual attendance fee and other contributions set by the General- Meeting; b) To comply with what is provided in these Statutes, the Association Regulations and the decisions of the governing bodies: c) Any other which are to be decided by the General-Meeting or the Board. Article 9 Members Resignation or exclusion 1. The following members lose their membership: a) Those which submit their resignation in writing; b) Those which have ceased to practice any of the activities mentioned in article 7; c) Those which fail to pay two fees, two attendance fees or any contribution set out in article 33 and which, after being required to pay do not do so within 30 days, or another timeframe set out by the Board, counting from the date of its reception; d) Those declared insolvent or are voluntarily or unofficially dissolved; e) The members with a conduct incompatible with the goal of the Association and, namely, which by action or omission adopt a conduct which goes against the principles and provisions of these Statutes notwithstanding the civil liability they incur before the Association and/or the other members; 2. It is up to the Board of Directors to decide on the members exclusion for the reason set out in subparagraph b) of the previous number, and such decision should always be preceded by the concerned member s hearing. 3. It is up to the General-Meeting the members exclusion for the reasons set out in subparagraphs c) to e) of number 1. 4. The members who submit their resignation or lose their membership according to the provisions of subparagraph c) of number 1 may be readmitted by the Board of 6
Directors, provided they require to do so and make proof of having previously paid any amounts owed to the Association. CHAPTER III Of the organization and operation Section I General provisions Article 10 Governing bodies The General-Meeting Board, the Board of Directors, the Supervisory Board and the Advisory Board are the governing bodies of the Association. Article 11 Term of office 1. The members of the General Meeting Board, the Board of Directors and the Supervisory Board are elected among the Permanent Members, for a two-year period, renewable up to two times, being its election and dismissal incumbent on the General- Meeting. 2. The election mentioned in number 1 is held by secret ballot and separate lists, in which the positions to be held shall be specified. 3. The application of a Permanent Member to the election for an office is held with simultaneous indication of the natural person who will represent it in the performance of such office. Article 12 Remuneration The elected offices are not to be remunerated. 7
Article 13 Dismissal 1. In case of resignation or dismissal of the governing bodies members of the Association, such bodies shall continue operational provided the majority of the members comprised by them are still in office. 2. There being the Chairman of the Board of Directors resignation or its dismissal by the General-Meeting, with no immediate election of a substitute, the other members of the Board should co-opt a new Chairman within 15 days counting from the resignation or dismissal date. 3. The co-optation of the Chairman of the Board of Directors mentioned in the previous number should be ratified by the first General-Meeting held after the mentioned cooptation. 4. If the new Chairman of the Board of Directors is not co-opted within the timeframe mentioned in number 2 or if the General-Meeting mentioned in the previous number does not ratify the co-optation which took place within that timeframe, all the offices of the other members of the Board cease automatically, and new members should be elected in compliance with these Statutes. Section II Of the General-Meeting Article 14 Constitution 1. The General-Meeting is constituted by all Permanent Members and is governed by a Board made up of a President and two Secretaries. 2. It is up to the Secretaries to assist the President and to replace him in his absence or impediment. 3. In case of the absence or impediment of any member of the Board it is up to the General Meeting, except for the case provided for in the final section of the previous number, to appoint, among the Permanent Members present, who should replace him. 4. Notwithstanding the provisions of subparagraph a) of no. 3 of article 8, the presence of external observers in General-Meetings may also be permitted, by decision of the president of the Board, revocable by decision of the General-Meeting, such as 8
representatives of the European Commission and the national authorities with competence in the medicinal products field. 5. The members of the Association should disclose, up to five days before the date of the General-Meeting, the name of its representative with voting powers. Article 15 Summonses 1. The summon of any General-Meeting should be carried out by the president of the board, by means of a registered letter with acknowledgement of receipt, sent to each one of the members, at least eight days in advance stating the day, time and place of the reunion as well as the respective agenda. 2. No decisions can be made on subjects outside the agenda, except if all Permanent Members are present or duly represented and all agree to the addendum. Article 16 Operation 1. The General-Meeting is held, ordinarily, twice a year, to carry out the approvals mentioned in n o. 1 of article 17. 2. The General-Meeting is held extraordinarily whenever the Board of Directors or the Supervisory Board so require or following the duly reasoned request of, at least, two thirds of the Permanent Members, notwithstanding the provisions of no. 3 of article 173 of the Civil Code. Article 17 Competences 1. It is up to the General-Meeting: a) To elect the respective Board, the members of the Board of Directors and those of the Supervisory Board and it may dismiss them at all times; b) To set out the policies, goals, procedures, methods and broad action lines necessary to the goal of the Association; c) To establish which subjects, except for the management ones, may be delegated on the Board of Directors; 9
d) To review, every year, based on the report prepared by the Board of Directors, the suitability of the structure of the Association and the available resources for its purposes; e) To discuss and approve until December 15th each year the annual budget for the following year; f) To discuss and approve, every year, the Report and Accounts of the Board of Directors, as well as the opinion of the Supervisory Board until April 30 th each year; g) To set, every year, the fees, attendance fees and other contributions to be paid by the Permanent Members and Associate Members, respectively, under proposal of the Board of Directors; h) To approve the internal regulations of the Association; i) To decide on the amendment of the Statutes; j) To decide on the admission of new members; k) To decide on the members exclusion according to the provisions of no. 3 of article 9; l) To decide on the moment and way of winding-up and dissolution of the Association, according to article 39; m) To decide on the admission of new members for the Advisory Board, according to the provisions of nos. 3 and 4 of article 30; n) To decide on the purchase, sale and encumbrance of real estate. 2. In the case provided for at the end section of subparagraph a) of the previous number, General-Meeting which carries out the mentioned discharge should ensure the management of the Association, appointing straight away one or more ad hoc committees made up of people appointed by the Permanent Members who will replace the members of the discharged bodies until new elections are held, these ad hoc committees being limited to the practice of day-to-day management acts of the Association and the General-Meeting should establish the timeframe to hold the elections. Article 18 Quorum 1. The General-Meeting can only be held, at first call, provided, at least, three of the five Groups are present or represented. 10
2. If thirty minutes have elapsed after the agreed time, the requirement provided for in the previous number is not met, the General-Meeting will be held at second call with any number of Permanent Members on the next second working day, at the same place, same time and with the same agenda, and this shall be expressly stated in the summon. Article 19 Decisions 1. Each group of Permanent Members has one vote in the General-Meeting. 2. Notwithstanding the provisions of the previous number, the decisions of the General- Meeting are taken by a majority of two thirds of the votes cast, notwithstanding the right of veto provided for in the next article and the decision provided for in n o. 1 of article 39. 3. The decision on the amendment of these Statutes is taken unanimously. 4. The non-voting is deemed to be an abstention and the abstention does not count for the calculation of the majorities. Article 20 Right of veto 1. Each Group has the right of veto regarding the decisions of the General-Meeting which entail an increase greater than 15% of the fee or the participation fee, each year. 2. Additionally, each of the Groups mentioned in subparagraphs a) and b) of no. 1 of article 7 has the right of veto regarding the decisions of the General-Meeting which entail increases greater than 20% in the annual budget against the previous year, except when that increase is necessary to meet EMVO requirements. Section III Of the Board of Directors Article 21 Composition 1. The management of the Association is entrusted to a Board of Directors elected by the General-Meeting and composed of seven members and it is incumbent on each Group 11
to propose a member, the other members being elected under joint proposal of all the Groups mentioned in no. 1 of article 7. 2. When electing the Board, the Chairman, Vice-Chairman and the Treasurer are appointed, the Chairman being elected by all the Groups mentioned in no. 1 of article 7. 3. The members of the Board of Directors are not remunerated. 4. The Chairman and, in his absence or impediment, the Vice-Chairman, should: a) Guarantee that the Board of Directors pursues, efficiently, its responsibilities of definition and implementation of the strategy set out by the General-Meeting; b) Summon and preside over the meetings of the Board; c) Carry out the policies decided by the Board; d) Propose to the Board suitable plans and once they are approved to manage its execution; e) Establish and maintain a suitable communication with all the members of the Board; f) Represent the Association in or out of court. Article 22 Competences of the Board 1. The Board of Directors should ensure that the Association complies with the legislation in force and these Statutes and, in general, the binding legal and contractual rules. 2. It is incumbent on the Board of Directors all the powers, except the ones provided for in article 17, necessary for the implementation of the policies, purposes, procedures, methods and action lines required to pursue the goal of the Association, namely, the following: a) To ensure that the Association operates in compliance with all the applicable laws and these Statutes; b) To propose to the General-Meeting the value of the membership fees, attendance fees, other contributions and charges to use the System; c) To ensure that the minutes of all meetings of the Board are taken and that its decisions are reported to all the members of the Association; d) To prepare the annual budget, as well as the annual Report and Accounts; e) To prepare a report on the suitability of the structure of the Association and the available resources to achieve its purposes; 12
f) To delegate the daily management or part of its powers on one or more board members, being able to appoint an Executive-Director of General-Director of the Association and/or outsource certain projects to third parties, such as EMVO; g) To set up, whenever necessary internal rules and procedures compatible with the Statutes in order to ensure the normal operation of the Association; h) To rent properties; i) To recruit qualified human resources to pursue the goal of the Association; j) To supervise the implementation and monitor the operation of the System, incident management, operational changes, the configuration management and the safety in accessing the data and to report such matters to the General-Meeting; k) To propose to General-Meeting measures related to the implementation and development of the System; l) To make written and duly substantiated recommendations to General-Meeting regarding the admission of new members and the termination of membership, whenever deemed necessary; m) To decide on the members exclusion according to the provisions of no. 2 of article 9 and on the reinstatement of members according to the provisions of no. 4 of article 9. Article 23 Operation 1. The Board of Directors should meet, at least, once every quarter. 2. Extraordinary meetings can be summoned upon request of, at least half the members of the Board of Directors. Article 24 Quorum The meetings of the Board can take place only when the majority of its members is present or represented by another member of the same body. Article 25 Decisions 1. All decisions regarding issues not provided for in the next number are taken by simple majority of the votes of the present or represented Board members. 13
2. The following acts are also subject to approval by a simple majority, which should include the affirmative votes of the Board members elected under proposal of each one of the Groups mentioned in subparagraphs a) and b) of no. 1 of article 7: a) Approval of expenditure greater than 100.000,00 except when they relate to payments to ICT service providers, which shall be governed by a separate contract; b) Amendment of the provisions of the service agreements with Central European Hub; c) Signing and amending the provisions of the contracts with ICT service providers; d) Approval of new or additional contributions according to the provisions of no. 7 of article 33; e) The appointment and dismissal of the Executive Director and General Director. 3. Each member of the Board of Directors shall have a vote on the decisions of the Board of Directors. 4. Non-voting is deemed to be an abstention and the latter does not count for the calculation of majorities. 5. Each Board member has the right of veto regarding the decisions of the Board of Directors which entail amendments to the principles agreed in terms of data accessing and management, provided these amendments relate to the data of each member of the concerned Group. 6. Additionally, each one of the members of the Board of Directors under proposal of each one of the Groups mentioned in subparagraphs a) and b) of no.1 of article 7 has the right of veto regarding the decisions of the Board which entail: a) Signing the contracts with ICT Service providers; b) Amendment of the contracts with ICT Service providers which involve deviations from the requirements set up by EMVO, notwithstanding those set up by the Directive, the Delegated Regulation or any other delegated acts which will be published. 7. The decision about the subject of subparagraph c) of no. 2 requires the affirmative vote of the board member elected under proposal of the Group mentioned in subparagraph d) of no.1 of Article 7 in so far as the signing of the contracts with ICT service providers may cause damage to the normal operation of pharmacies. 14
Article 26 Obligation of the Association To oblige the Association the signatures of two Board members are necessary and sufficient, one of them being that of the Chairman, the Vice-Chairman or the Treasurer whenever documents regarding cash holdings or accounts are involved. Section IV Of the Supervisory Board Article 27 Constitution 1. The Supervisory Board is constituted by three members, one being the President and two Councillors. 2. One of the members of the Supervisory Board should be a Statutory Auditor. 3. The President is replaced for his impediments and absences by the Councillor appointed by the Supervisory Board itself during its first meeting. Article 28 Competences of the Supervisory Board 1. It is up to the Supervisory Board: a) To examine, whenever deemed appropriate, the accounts of the Association and the treasury services; b) To give advice on the annual Report and Accounts and any other matters submitted to it by the general-meeting or the Board of Directors; c) To ensure the compliance with statutory and regulatory provisions. 2. The opinion of the Supervisory Board on the annual Report and Accounts should be given within, at most, 15 days, counting from the date such documents are submitted to it by the Board of Directors. 3. The members of the Supervisory Board may attend the meetings of the Board of Directors whenever deemed necessary by it, or at request of the latter, although they cannot vote on the respective decisions. 15
Article 29 Operation, quorum and decisions 1. The Supervisory Board is held whenever deemed necessary, but not less than once each quarter, and operates provided the majority of its members is present. 2. The decisions of the Supervisory Board are taken by an absolute majority of the votes of its attending members. Section V Of the Advisory Board Article 30 Constitution 1. Public bodies with regulation and supervision duties or responsibilities in the field of medicinal products may be part of the Advisory Board. 2. The Board members are, by that token, part of the Advisory Board. 3. The admission of members in the Advisory Board depends on the decision of the General-Meeting, which checks the adherence of the interested parties to these Statutes, as well as their respective duties and responsibilities, according to the provisions of number 1. 4. The decision provided for in the previous number depends on a proposal of the Board of Directors, by means of a written request addressed to it by the interested parties showing their compliance with the requirements and conditions necessary for the decision by the General-Meeting. Article 31 Competences of the Advisory Board It is incumbent on the Advisory Board the general follow-up of the System s operation. Article 32 Operation The Advisory Board should meet in ordinary sessions, at least twice a year and whenever deemed necessary. 16
Section VI Of the Financial Scheme Article 33 Costs of the System, membership fees and attendance fees 1. The Groups mentioned in subparagraphs a) and b) of no. 1 of article 7 as well as the manufacturers of medicinal products provided with safety devices which are not Permanent Members ensure the payment of the installation, maintenance and updating costs of the System, according to a proportion of 85% for the former and 15% for the latter, in terms to be set up by the General Meeting under proposal of the Board of Directors. 2. To face the organization and management expenditure of the Association, each Group ensures the payment of an annual fee the amount of which is set by the General- Meeting under proposal of the Board of Directors. 3. The amount of each fee is borne by the Members of each Group according to the principle set out on no. 2 of article 7. 4. The Associate Members are responsible for the payment of an annual attendance fee, the amount of which is set by the General-Meeting under proposal of the Board of Directors. 5. The payment of the membership fees and attendance rates should be made within 30 days counting from the date the respective invoice is issued. 6. The total amount of the membership fees and attendance fees is used to face the installation, organization and management expenditure of the Association. 7. The Board of Directors may propose to the General-Meeting new or additional contributions for Permanent and Associate Members to face the funding of special projects or other expenditures not included in the annual budget, applying the provisions of number 4 of this article and of no. 2 of article 7, with the due adjustments. Article 34 Budget 1. The Association has an annual budget, corresponding to the calendar year, which is prepared by the Board of Directors and approved in General-Meeting and which should cover the expenditure resulting from its management. 17
2. During any accounting year an extraordinary budget may be proposed in duly justified cases. Article 35 Revenue of the Association The revenue of the association includes: a) The amount of the membership fees and attendance fees paid by the Members and all other contributions; b) Interest of bank deposits; c) The revenue of the Association s own assets; d) Subsidies, donations, legacies or gifts granted to it. Article 36 Expenditure of the Association The expenditure of the Association is the one necessary to fulfil its goal. Article 37 Report and Accounts 1. The Board of Directors should prepare the annual Report and Accounts reported to December 31 st of each year. 2. The documents mentioned in the previous numbers should be accompanied with the advice of the Supervisory Board, according to the provisions of subparagraph b) of no. 1 of article 28, and be submitted to be assessed by the annual General-Meeting. CHAPTER IV General Provisions Article 38 Accounting year The accounting year coincides with the calendar year. 18
Article 39 Winding-up and liquidation 1. The Association may be dissolved by unanimous decision of the General-Meeting, expressly summoned for that purpose. 2. It is incumbent on the General-Meeting that decides on the dissolution to appoint a winding-up committee, the type and the deadline for the liquidation of the assets of the Association. 3. The destination of the remaining assets of the Association, which were not allocated to specific purposes is to be decided by the Permanent Members. Article 40 Jurisdiction 1. Permanent Members will use their best endeavours to settle amicably any disputes regarding the interpretation and application of these Statutes. 2. In the absence of an agreement, any of the Parties may submit the issue to arbitrage, which shall be conducted according to the Arbitration Rules of the Portuguese Chamber of Commerce and Industry (Commercial Arbitration Centre) and the arbitration decision cannot be appealed. 19