discussion document memorandum of understanding mou v1... · discussion document memorandum of...

Discussion document

Memorandum of Understanding

Creation of the BeMVO

Basis for negotiation with all Parties

Version 1.2

January, 17th 2017

MOU - v.1.2 - 17JAN2017– basis for negotiation with all Parties Not to be disclosed to third parties

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Table of content

Definitions ............................................................................................................................................. 3

Introduction and general context ................................................................................................. 7

General description of the system ................................................................................................ 9 The System ....................................................................................................................................................... 9 EMVO ................................................................................................................................................................11 NMVO ................................................................................................................................................................11

General commitments ..................................................................................................................... 12

Scope – Products affected .............................................................................................................. 12

Time line .............................................................................................................................................. 13

Ownership of the System ............................................................................................................... 14 Ownership and financing of the European HUB ...............................................................................14 Ownership and financing of the Belgian repository .......................................................................15

Data set for Product Verification – Data Serialisation ......................................................... 16

Ownership of data ............................................................................................................................ 16

Use of the repository system and its data for Other Purposes ......................................... 17

Access to the System – log in and rights management ........................................................ 18

Access to supplementary information - Stakeholder Access Scenarios and Conditions ........................................................................................................................................... 18

Description of Use of system and the roles and responsibilities of the relevant stakeholders. ...................................................................................................................................... 20

Collaboration with the LMVO ....................................................................................................... 23

Financing of the repository ........................................................................................................... 24 Contributions by the MarketingAH .......................................................................................................25 Pre financing of the development costs of the national repository ..........................................25

Organisational and Governance Structure: Key Parameters ............................................ 27 Purpose and activities................................................................................................................................27 Constituencies ...............................................................................................................................................28 Members .........................................................................................................................................................29 Resignation - Suspension - Exclusion - Procedure of withdrawal of membership rights .33

Governance of the BeMVO ............................................................................................................. 34 The General Assembly ...............................................................................................................................34 The Board of Directors ..............................................................................................................................38 Chair, Vice-chair and Treasurer .............................................................................................................43 Managing Director or General Manager ..............................................................................................43

Commitments to secure an orderly process of development and roll out of the BeMVS. .................................................................................................................................................. 44


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Definitions

1. BeMVO – Belgian Medicines Verification Organisation – the national association that will be 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. 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) will be decommissioned. In this system the operational data will be gathered, updated and reporting activities will be generated.

3. Blue Print Model – A set of documents containing:

(1) 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

(2) 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.

4. 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

5. 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, …


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6. 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 n the EEA to be checked.

7. URS – User Requirements Specifications – The Core documents that are expressly identified as such by EMVO.

8. 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.

9. 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 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.

10. FMD – Falsified Medicines Directive (Directive 2011/62/EU - FMD

amending Directive 2001/83/EC),

11. ICT – Information and Communication Technology.

12. UI - Unique Identifier or randomised number being uploaded in the NMVS ensuring that a product is coming from a genuine and recognised manufacturing plant.

13. Interoperability – Different systems that can interact but have different modi-operandi.

14. LMVO – Luxembourg Medicines Verification Organisation.

15. Manufacturers - For the purposes of this paper, 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


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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.

16. Marketing Authorisation Holder(s) or MAH – For the purpose of this paper 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). 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.

17. 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.

18. 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.

19. Members – Full Members - Full members are part of a constituency with voting rights in the General Assembly and do have the right to appoint a director or a observer in the Board of Directors.

20. Members - Affiliate Members – Affiliate members can participate in the General Assembly but do not have voting rights, nor the right to appoint a director or observer in the Board of Directors.

21. NCA – National Competent Authority, for Belgium FAGG/AFMPS

22. 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

23. Parties – The stakeholders, on a national level and co-signers of the MOU. We aim at having eight Parties (in alphabetic order):

- ABPH-BVZA, - ANGR-NVGV - APB, - BACHI - BAPI, - FEBELGEN,


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- OPHACO, - PHARMA.BE.

24. 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.

25. Pharmacy – Pharmacy cover both community and hospital pharmacies, except when specified differently in the text

26. Stakeholders – May be an individual member of one of the above Parties or any other user of the system, or any interested body including government departments and agencies

27. System - Collectively, the European Hub (European Medicines Verification System) and the national/regional repositories are called the “System”.

28. 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.


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Introduction and general context

29. Patient health and safety is of the utmost importance to the pharmaceutical industry, parallel distributors, wholesalers and pharmacists. The infiltration of falsified medicines in the European supply chain is a real concern.

30. In order to counter this threat, the European Parliament and Council have released a Directive on Falsified Medicines (2011/62/EU amending Directive 2001/83/EC), which aims at improving patient safety by mandating the Marketing Authorisation Holders and manufacturers to put

in place a system to prevent falsified medicines from entering the legal supply chain.

31. The Directive on Falsified Medicines introduces mandatory, harmonised pan-European safety features in the form of

- tamper evident (TE) packaging and - a unique identifier (UI) for medicine authentication

to be applied to all prescription medicines subject to possible exclusions based on risk assessment.

32. The Delegated Regulation (EU) 2016/161 defines the characteristics and technical specifications of the “unique identifier” allowing identification of individual packs, and the accessibility of national product databases or repositories that allow verification of each dispensed pack.

33. The directive also specifies that the manufacturers will fund the cost of the System and that the operation should be supported by a non-profit organization that is set up by the Marketing Authorization Holders and managed by all stakeholders.

34. All Parties fully support this legislation and will work with the EU

Commission, the National Competent Authorities and together in establishing an effective system in the interests of patient safety.

35. To this end, the Parties have collaborated in the elaboration of this Memorandum of Understanding with a view to jointly promoting the development of a cost effective and scalable product verification system - in line with the blueprint model - that is to be run by the stakeholder’s organisation on a non-profit basis in a way that justifies the related costs to be borne by the relevant Parties.

36. This Memorandum of Understanding between the Parties will describe: - The conditions for the joint implementation of the Belgian system

to meet the requirements of the Directive, - The system for coding medicines in Belgium


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- The governance rules of the BeMVO at all levels - The outline of the collaboration model with the LMVO - The ownership of the system and of the data - The potential business model for development of commercial

actions, if any - The organisation model - The principles of the cost allocation model - The financing and pre-financing principles - The scope of the verification activities - The specific roles and responsibilities of each of the stakeholders

within the “system”

37. This MoU is not intended to be legally binding but is an expression of the fundamental policy principles agreed between the Parties who continue to work together in defining the set-up of the BeMVO and the governance rules.


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General description of the system

38. In essence, manufactures will attribute to each pack of medicines – in scope - a unique identifier (UI)

39. The Marketing Authorisation Holder has to upload the UI information in the European Hub.

40. They will be required to print a Data Matrix code, which incorporate the UI to the outer packaging of all medicines under the scope of the FMD in Belgium 1 for each individual sales package. The UI will also be required for all reimbursable medicines.

41. They will be required to apply an anti-tampering device to the outer packaging of all medicines under the scope of the FMD in Belgium for each individual sales package. At the point of dispense the medicines under the scope of the FMD and reimbursable medicines (included reimbursable OTC) will be scanned, checked and verified for authenticity against the national (or supranational) repository. (Only Hospital Pharmacies can decommission earlier in the process).

42. If the UI on the pack matches the information in the repository and the pack is ‘available’, the pack is decommissioned and supplied to the patient. Otherwise, if there is a warning related to the pack, then the system will highlight this as an exceptional event and the package will not be supplied to the patient. An investigation needs to determine whether the pack has been falsified or not.

The System

43. The System is composed of a European Hub connected to a series of national (or regional) data repositories

1 All prescription medicines, with some exceptions cf DR Annex 1; OTC medicines included in Annex 2.


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A. European HUB

44. In a joint initiative, EU stakeholders representing manufacturers, wholesalers and community pharmacist have defined a cost-effective approach to the repositories system according to the requirements of the FMD.

45. The Hub will have following functions/specifications / characteristics:

- Be interoperable between the various countries; - Act as centralized location for upload and storage of product

master data for Marketing Authorisation Holders; - The single entity from which national system can obtain revised

/new product serialisation data;

- Serving as the platform for registered MarketingAH to mark a product pack as ‘decommissioned’ (when product is recalled, taken out of the supply chain, exported out of EU,...)

- A means by which multi-country packs can be systematically marked as ‘decommissioned’ in all affected markets once a pack has been dispensed in one market;

- A mechanism by which parallel distributed product can be reconciled at a batch level;

- A central point from which product recall actions can be initiated (without prejudice to the ability of the responsible Marketing Authorisation Holder to initiate a recall in accordance with established recall procedures at national level);


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- A central point from which those alerts that cannot be handled solely at the national level can be managed; the System design will generate alerts in case the automatic checking procedures detect an Exceptional Event.

46. No pharmacy or wholesale level data shall be available on the European central Hub.

47. The verification of medicines will take place in the National Medicines Verification Systems.

B. National Medicines Verification System (NMVS)

48. The main purpose of the national system is to serve as the verification platform to which pharmacies, other persons authorised to supply medicines to the public and wholesalers connect in order to verify the authenticity of an individual pack.

49. The NMVS fulfils the requirements of a national repository as stipulated by the European legislation. The key tasks of the NMVS are:

- Receiving revised/new product serialisation data from the European Hub.

- Serving as the verification platform for pharmacies or other registered parties such as wholesalers to check a pack’s authenticity.

- Serving as the platform for pharmacies and wholesalers, to mark a product pack as ‘decommissioned’.

EMVO

50. The European Hub will be established and managed by a not-for-profit

stakeholder organisation referred to as the “EMVO” (European Medicines Verification Organisation).

NMVO

51. Article 31 of the DR requests that the national repository system shall be set up and managed by a non- profit legal entity, which is established by manufacturers and marketing authorisation holders. Wholesalers and pharmacists are entitled to participate in the NMVO on a voluntary basis.

52. The name of the Belgian NMVO will be BeMVO.


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General commitments

53. All parties agree that the BeMVO is striving for alignment and compliance with the Blueprint Model.

54. Following Specific Belgian requirements have been defined and will be added to comply to the National Competent Authorities Requirements of BE & GDL:

a) GTIN-CNK conversion table;

b) Export to RIZIV on behalf of all MAH of the UI intended to the Belgian market for allowing the reimbursement delivery verification;

c) Creation of a repository covering the Belgian and Luxemburg market but with separate event databases for Belgium and GD Luxemburg;

d) Summary overview for the MarketingAH on the status of their own packs.

55. The Parties fully accept the need for working in alignment with a comprehensive framework for the implementation of het Directive, determining, amongst other issues, data access, control conditions and operational rules.

56. All Parties are aware of the fact that the implementation of the System will have operational consequences in the supply chain of medicines.

57. All Parties will work together in a cooperative way to make sure that the operational and financial burden of each individual user of the system is minimal and in line with its financial and operational capacity of that user.

Scope – Products affected

58. Products that are in scope of the FMD are all prescription products.

59. The Belgian Competent Authorities enlarged the scope as follows:

- Use of the UI

- All medicinal products subject to prescription - Plus Black List - Minus White List - Plus all reimbursable products in BE bearing a RIZIV/INAMI serial

bar code today.


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- Use of the ATD

- All medicinal products subject to prescription - Plus Black List - Minus White List - Plus all other medicinal products on a voluntary basis

2D bar code for products out of scope

60. 58 The parties confirm that, for the products out of scope, the use of the

2D bar code (without a UI) will be on a voluntary basis.

Time line

61. The FMD requires full implementation of the system no later than 36 months after the publication of the DR in the official journal of the European Union on the 9th of February 2016.

62. For countries that have a system (BE, IT, GR) in place that verifies individual medicines, the FMD foresees the possibility of having an additional 6 years to implement.

63. All parties understood the Belgian Authorities do not want to use the option of additional delay on the implementation; on top a delay is not possible due to collaboration with the Grand Duchy of Luxembourg, a market being served in minimum 80 % of the cases out of Belgian Country packs

64. This means that Belgium must have the national system up and running by 9th February 2019. This includes the connection to the European Hub and the connection to all national users (pharmacies, wholesalers etc.).

65. Practically speaking the system must be ready latest 6 months before the deadline at the latest to be able to:

- Run the mandatory Blueprint Validation period of 6 months to test the repository system and the underlying procedures

- Test all links with the in house systems of related stakeholders, in their different configurations

- Make sure all involved stakeholders are informed about the new approach and procedures

- Allowing sufficient time for training of the users to be full operational by 9th February 2019


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- Test response times on a full operational load to be in line with set target in URS

66. It is foreseen that the development of the national repository will take at least 18 months. By consequence, the signature of the contract between the BeMVO and the ICT provider should not be later than March 2017.

67. As a consequence the BeMVO should be operational by that time.

68. It will be allowed for companies at EU-level to bring packs on the market with the new UI before February 9, 2019 on the condition that they will

have to perform a retro-active upload of the unique identifiers once the system in Belgium will be operational.

69. Companies will be allowed to bring products on the Belgian market with the new coding system as from July 2017. (Note for all Parties: This is a target time line, but is explicit subject for further negotiation))

For this to happen, all parties agree that all efforts have to be done so that:

- The conversion table between the GTIN-product code and the CNK-code is operational and integrated in the software of the distribution chain;

- The tarification instructions of RIZIV/INAMI and underlying legislation are adapted and integrated in the software of the pharmacists so that they can transmit the individual number coming from the sequential bar code or the individual number coming from the 2D bar code depending on the packaging they are dispensing;

- Scanning hardware and software of pharmacists is already adapted

so that they can read the 2D codes

70. All parties agree to act according to these timelines and will do their best efforts to achieve this.

Ownership of the System

Ownership and financing of the European HUB

71. It is known to all Parties that the European stakeholder organisations representing Manufacturing Authorisation Holders agree an equitable and


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proportionate means of sharing the upfront costs and on-going operations costs of establishing the European Hub.

72. It is as well known to all Parties that to the extent that the establishment of the System at the level of the European Hub requires any capital investment in equipment or other assets, including any intellectual property rights, such assets will be the property of the EMVO.

Ownership and financing of the Belgian repository

73. The costs of building the Belgian product verification and authentication system (‘BeMVS’) will be borne by the MarketingAH putting products in scope on the market for Belgium and GD Luxemburg.

74. To the extent that the establishment of the repository at the Belgian level requires any capital investment in equipment or other assets, including any intellectual property rights, such assets will be the property of the BeMVO.

75. To adapt the system to the Belgian situation a conversion table GTIN-CNK will be used.

76. The only valid conversion table GTIN-CNK that will be used, will be produced and managed by APB. This will be the case as long as

- APB will adapt the conversion table on regular bases and each time this is needed for the good functioning of the system and/or if one of the related stakeholders requests this.

- The conversion table covers all products bearing a GTIN – code.

- The conversation table (1) will be for free and (2) openly distributed and available for all parties, without any conditions

- APB guarantees an easy and client friendly distribution procedure.

77. APB is deemed to provide the service as long as one of the concerned stakeholders is requesting for the conversion table service.

78. Capital investments subsequently made by other stakeholders in relation to the System (such as the acquisition of scanners and related software) shall be owned by the respective stakeholders making those investments.

79. All parties are fully aware of the fact that internal working procedures of stakeholders might be impacted by the implementation of the new regulation. Costs to adapt these procedures and underlying systems are borne by the related stakeholder.


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Data set for Product Verification – Data Serialisation

80. Parties agree that the serialisation System shall hold the following essential data components, (as mentioned in act. 33.2 of the DR)

- Product code (as later stipulated GTIN code) - Batch number and, in the case of parallel distributed products,

suffixes where appropriate, in addition to a link to the original manufacturer’s batch number,

- Expiry date, - Serial number,

- The current status of the unique serialisation number (i.e., commissioned, de-commissioned, dispensed),

- By whom/where a change of status has happened, - Time and date of the change of status - A set of product master data

81. For the product code all Parties agree to opt for the GTIN as the leading product identifier.

82. The information that will be stored in the 2D barcode are :

- GTIN Code - Batch No - Expiry date - Unique Identifier

83. The manufacturers and MarketingAH of OTC medicines in Belgium have decided to apply also, on a voluntary basis, the 2D barcode on the external packaging of their products. This 2D barcode will contain:

- GTIN code - Batch No

- Expiry date

Ownership of data

84. In view of the general principles on ownership it is considered that marketing authorization holders and/or parallel importers own their own product data, uploaded in the Hub.

85. This information is enriched with transactional data belonging to the pharmacist, in relations to the pharmacist verification, to the wholesaler, in relation to the wholesaler verification, to the parallel distributor in relation to his activities and MarketingAH in relation to his activities.


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86. Data ownership of sales data and transactional data is still under discussion between the concerned EU organisations. All parties agree to accept the outcome of the agreement between the EU organisations.

Use of the repository system and its data for Other Purposes

87. In addition to providing all stakeholders with more detailed information on counterfeit products found on the market, the implementation of the proposed System that allows product identification at pack level, has the potential to generate other benefits that include,

- Export to RIZIV/INAMI on behalf of all MAH of the UI intended to the Belgian Market for allowing the reimbursement delivery verification

- Higher effectiveness in preventing recalled products (in scope of the FMD) from being supplied to the patient

88. The government has – in line with the providing’s in art 39 of the DR – the right to use the database for three domains

- Supervising the functioning of the repositories and investigating potential incidents of falsification;`

- Reimbursement - Pharmacovigilance or Pharmacoepidemiology

89. All parties agree that the system will not be used for reimbursement purposes.

90. All parties agree that the additional use of the repositories system and/or of the data in the system – be it in general terms (e.g. messaging service with information to patient) – be it more specific terms (e.g. use of specific data created by companies, wholesalers, pharmacies for

statistical purpose) requires the consent of the concerned associations and stakeholders on a case-by-case basis in compliance with Belgian relevant legislation.

91. Specifically concerning the commercial use of data, all parties agree that the current habits inherited from the past (by pharmacists, wholesalers, hospital pharmacies) will not change, under the condition that this habit is not forbidden by the upcoming agreement with between the EU stakeholder associations.

92. Likewise, the Board of Directors of the BeMVO can decide to create a subsidiary of the BeMVO to produce, distribute and sell data. The kind of information, the level of detail and the level of compensation towards the


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pharmacists, wholesalers and hospital pharmacies for allowing these data to be used, is subject of negotiations.

93. To develop this scenario, two levels of decisions are needed

- Level 1 – the association level: the associations can decide upon the use or not use of data for purposes other than verification purpose. Each association has a veto right in the Board of Directors on the collaboration of his members to the system.

- Level 2 – the individual stakeholders level: each individual stakeholder

can decide on the use of his own data – under the condition that on level 1 the concerned association agreed on the principle to use the data for commercial activities.

Access to the System – log in and rights management

94. The Parties recognise that for security reasons, access to the System should be strictly limited on a needs only basis to those trusted stakeholders who physically handle products in the supply chain.

95. Levels of access will vary depending on the nature of the activity as outlined below.

96. The system will provide a rights management system making sure the right levels of access are in accordance with the nature of the activity of the stakeholder.

97. Each Party is committed to stimulate a proper and in-time implementation of the legal mandatory FMD requirements.

Access to supplementary information - Stakeholder Access Scenarios and Conditions

98. The Parties are aware of the fact that the EMVO and his European stakeholders have identified and agreed the following scenarios where relevant stakeholders would seek access to certain serialisation and product verification information for reasons of patient safety:

A. Negative verification and dispensing and unusual activity

99. Access to information in the System on impacted serial numbers would allow for quicker investigations into Exceptional Events that indicate a risk of counterfeit product. The parameters of unusual activity are to be defined within the System. The information involved might include, by way of example, evidence that:


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- The serial number is not in the verification system, - The data elements that are scanned do not match the database

information, - The serial number is already logged as dispensed, - The serial number has already been decommissioned (e.g. where

the product has been repackaged and a new serial number has been established),

- The serial number has already been decommissioned due to recall of a batch,

- Any activity relating to a specific serial number or to a set of serial numbers reflecting practical impossibility relating to time, geography, manufacturer’s capacity, or suggesting an attack on the System.

100. While it is recognised that local regulatory authorities will naturally be involved at a national level, each affected manufacturer will require some extended data to help track down the source of the incident.

101. The design of the System will ensure that only the agreed and relevant extended data are made available under these conditions and the European Hub will be responsible for requesting and receiving such data from the relevant national system(s) in order to provide the requisite level of data abstraction to allow MAH to fulfil their obligations vis-à-vis the regulators.

B. Product recalls

102. Using the status information relating to individual packs, the System would provide near real time identification of information for impacted batches and allow recalls to be more effectively managed.

103. In a product recall scenario, relevant stakeholders would require access

to the status of all impacted serial numbers, including details of which impacted serial numbers have been dispensed or re-packed in accordance with the agreed processes on the handling of Exceptional Events and in line with relevant data protection laws. For repacked parallel distributed products, the original manufacturer’s and the new batch numbers being applied by the parallel distributor must be linked in the System to permit rapid and efficient recalls.

104. Again, the European Hub will allow for the appropriate level of data abstraction in terms of what data can be obtained from national/regional repositories and made available to individual manufacturers.


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C. System check and maintenance

105. When running the ICT system, occasionally it will be necessary to check whether a transaction(s) has taken place or has successfully completed or to change data when an error has occurred. In these circumstances, the ability to run a report or at least to access data will be required. Access in these circumstances would be limited to authorised ICT contractors subject to appropriate safeguards.

Security Audits

106. All Parties endorse the need for and collaboration in the potential ad hoc security audits that could be held in the organisations using the system.

Description of use of system and roles and responsibilities of relevant stakeholders.

107. All Parties agrees that all relevant stakeholders should work according the processes described below.

A. Controlling Entry and Exit

108. For security reasons, access to the System should be strictly limited on a needs only basis to those stakeholders who physically handle products in the supply chain. Levels of access will vary depending on the nature of the activity as outlined below.

109. Entry Points: A key feature of the System is to offer a single point of entry for MARKETING AUTHORIZATION HOLDER data (check in) at European Hub level. Only the MAH can enter serial numbers into the system. That basic information will allow for subsequent verification of the product pack by other stakeholders physically handling product in the supply chain.

110. Exit Points: The System will only work if exit points are identified and comply with the System in accordance with the agreed procedures. The exit points and rights of access to the System are identified below:

- MarketingAH (check in, check out, verification rights), - Authorised wholesalers (verification of authenticity, check out for

specific cases), - Pharmacies (pharmacies open to the public and hospital

pharmacies).


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111. In some specific instances there will be a requirement for an “undo” capability within the System where a serial number has accidently or prematurely been “checked out”, for example, where a product has been prepared for dispense but is not collected by the patient (DR art 13).

B. The “Check Out” Process

112. Once introduced into the System, products must subsequently be “checked out” (meaning that their serialization numbers are to be decommissioned) by the relevant stakeholders in the following scenarios:

- By the MAH in the event of product returns, recalls, accidents, damaged products, the correction of uploading errors in the initial check in phase, unforeseen logistics adjustments, theft of serialisation numbers/packs, retention and reference sample collection, transformation into medical samples or use for clinical trials, early access programs, compassionate use or medical need programs;

- By the parallel distributor (check out prior to repackaging and subsequent application of new serialisation numbers);

- By the retail pharmacists on delivery (using scanning technology) or at the first opening of the pack in case of the IMV dispensation;

- By the hospital pharmacists on reception of the packs or on dispensation to patient (or any moment in between);

- By wholesalers in the event of (1) destruction by the wholesale distributor or (2) when returned by pharmacists, or (3) individual product sale to another EEA Member State, or (4) their export outside of the EEA/other participating countries., or (5) other cases as defined in Article23 of the Delegated Regulations.

113. Unless every individual serialized pack is correctly “checked out” at each of the points listed above, patients will not benefit fully from the safety

features. The unique serial number can only provide protection against counterfeits if it is systematically checked out and the status changed on the database to “dispensed” when the product is handed to the patient or repackaged by a parallel distributor.

C. The Subsequent “Check In” Process for repackaging

114. All participating MAH must commission a new serial number in the systems in the countries of intended sale (“check in”). This will be a highly automated and straightforward process.

115. Subject to the agreed data access principles, the information to be provided by MAH in the code to be affixed to each pack should include


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the product identification code (the expiry date, the originator's batch number, suffix or prefix (where the MAH is repackaging), and the new serial number that ensures the product can be matched with the issuing MAH, as well as satisfying the relevant labelling/identification requirements at national level.

116. A link – at batch level - between the set of newly commissioned serial numbers and the originator’s set of serial numbers is necessary to enable the System in a timely manner to reconcile parallel distributed products by verifying that the number of doses 'decommissioned' does not exceed the number of doses subsequently checked in or 'commissioned' into the

system.

117. In the case of repacking and for practical reasons and reasons of proportionality, the link must be established between a number of decommissioned (checked out) serial numbers from any one production batch of the original MAH, and the number of new serial numbers checked in. This simple rule makes the System as robust as possible in terms of safeguarding patient safety by:

- Facilitating product verification, - Enabling the swift recall of original and repackaged products

should that prove necessary for whatever reason, - Ensuring that leftover products from individual packs that are

assembled into a new pack have the same expiry date.

D. Access by Wholesalers

118. Wholesalers will have “read” access for verification purposes. The delivery units containing medicinal products which carry safety features on the outer packaging must be checked by the wholesale distributor.

119. For medicinal products carrying safety features obtained from the

Manufacturing Authorisation Holder or the Marketing Authorization Holder, or a person who is authorized by them to supply these products, the wholesale distributor is, however, deemed to have satisfied the condition above and thereby Article 80(a)(ca) of the Directive.

120. The receiving wholesale distributor must check the medicinal products carrying safety features on the outer packaging obtained from other authorised sources. Similarly, if medicinal products are returned from persons authorized or entitled to supply to the public, the wholesale distributor must verify that they are not falsified or tampered with by checking the safety features on the outer packaging.


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121. The scope and application of the verification process of the safety features at the level of the wholesale distributor is determined by the Delegated Regulations (articles 20-24).

122. The Parties agree to continue the dialogue to develop ways of working in the case of events which require the removal of products from the supply chain (such as damaged goods) and for which the serial numbers should be decommissioned from the System.

E. Dispensing Pharmacies, Hospitals

123. Pharmacies will have “read” access for verification purposes. The decommissioning of packs that are dispensed by registered pharmacies (including registered on-line pharmacies) hospital pharmacies through the use of scanners must be mandatory so that the system is closed and effective in terms of ensuring patient safety.

F. Importance of decommissioning

124. Unless every individual serialized pack is correctly “checked out” at each of the points listed above, patients will not benefit fully from the safety features. The unique serial number can only provide protection against counterfeits if it is systematically checked out and the status changed on the database to “dispensed” when the product is handed to the patient or repackaged by a parallel distributor.

Collaboration with the LMVO

125. In a continuous attempt to reduce the cost of development of the national repository system and of the operating costs of the BeMVO the Parties agree to investigate, negotiate and conclude collaboration with

the LMVO.

126. In search for economics of scale, the BeMVO could collaborate with third countries, under the condition this collaboration has no impact on timing of decision and roll out of the BeMVS and no impact on the targeted collaboration with the LMVO.

127. The related Luxemburg stakeholders and the competent authority took the decision to create an autonomous NMVO, called LMVO. They are open to investigate the possibility to use the “Belgian” national repository system / platform under some conditions:

- The common system must be able to separate Luxembourg transaction and connection log information from the activities


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originating from Belgian stakeholders. This information should only be accessible to the Luxembourg stakeholders / authorities , according the access security principles, and to the designated operational teams and system administrators

- Adapting the system to specific Luxemburg situations, if any. if these specific requirements induce additional costs, they will be covered by the LMVO

- Having the possibility to define the specific reporting needs. In case the requested reporting is deviating from the Blueprint defined reports and is inducing additional costs, then these costs will be covered by the LMVO

- Receiving technical and operational support from the BeMVO in the use of the system

- The service levels should be similar as defined in the URS and the SLA and governance procedures defined in the Blueprint IT service provider agreement

128. All Parties agree and support the investigation for further collaboration, along the following lines

- The Luxemburg LMVO should pay her fair share in the development and running costs of the system

- Decisions of Board of Directors or the GA on higher / lower contribution fees to finance the development and running cost of the system will have immediate impact on the fair share of the LMVO

- LMVO is responsible for the collection of the allocation fees to be paid by Luxemburg Stakeholders

- Development- and running costs related to Luxemburg specific situation are borne by the Luxemburg stakeholders

- The Luxemburg stakeholders and authorities have no access the Belgian transactional and connection log information

- The collaboration between the two NMVO’s can have no impact on the governing structures of both organisations

129. It is suggested not to go for a tri-partite contract with the ICT provider, but a contract between the ICT provider and the BeMVO. The BeMVO will conclude a contract and service level agreement with the LMVO.

130. During the negotiations BeMVO will be in contact with the LMVO to learn the specific requests of the LMVO stakeholders.

Financing of the repository


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Contributions by the MarketingAH

131. As said the costs of the product verification and authentication system will be borne by the different Marketing Authorization Holders having medicinal products on the Belgian market and bearing the safety features referred to in Article 54a e) of the European Directive.

132. All relevant parties agree that the costs will be shared on a flat fee bases per active MAH distributing medicinal products – within the agreed scope of the FMD (see paragraph 58 and 59) - on the Belgian market.

133. An active MarketingAH can be defined as an MarketingAH that distributes in an organized way on the Belgian market; excluding the accidental cross border delivery on the initiative of a physician prescribing in the interest of a specific patient/individual.

134. The BeMVO will be responsible for the detection and collection of the contributions.

135. For that purpose BeMVO have to conclude a contract with each of the MarketingAH active in Belgium. The identification of these active MAH will be done by way of

- Self registration in the EU-Hub - Upload of this information in the Belgian repository - Control on free-riders in the events database

Pre financing of the development costs of the national repository

136. As the collection of investment funds towards the MarketingAH can only start at the moment the verification system is fully operational (Q1 2019),

the costs of the creation of the BeMVO, the cost concerning the selection of the IP provider as well as the development costs of the national repository system has to be pre financed.

137. The stakeholders financing the national repository will have to elaborate an appropriate pre-financing mechanism. The pre financing mechanism could be a combination of different elements as

- Loan from the IT provider - Adapted /Delayed invoicing mechanism - Comfortable paying scheme - Loan from individual manufactures / MAH - Bank loan organized by the related constituencies or by the BeMVO - ….


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138. All parties agree it is the sole responsibility of the stakeholders financing the BeMVSystem to decide on the pre-financing mechanism.

139. All parties fully accept the possibility of embedding the pre-financing mechanism (eg bankloan) in the BeMVO, once created.

140. All above start-up costs (as mentioned in paragraph 126) borne by individual companies or associations will be reimbursed upon request by simple letter immediately to the concerned companies / associations once the BeMVO is created.


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Organisational and Governance Structure: Key Parameters

141. The BeMVO will be established as a not-for-profit organisation for an unlimited term. Its Statutes will formalise its legal status, financing, organisational structure and decision-making processes.

142. Without prejudice to a final decision on the most cost-effective legal structure and any related mandatory legal requirements, the Parties envisage that the BeMVO will be governed by the principles outlined in this chapter.

143. The BeMVO will hold minimal assets and the project will be outsourced to one ICT supplier in a project financed type programme governed by a contract conferring control rights to the BeMVO tantamount to ownership rights concerning the ICT system (technology).

Purpose and activities

144. The BeMVO will establish and manage on behalf of the Stakeholders the National Repository System and link with European HUB in compliance with all Blueprint requirements.

145. In addition, the association’s non-profit purpose is to cooperate with the relevant stakeholders in the implementation of the EU Directive on Falsified Medicines and its Delegated Regulations.

146. The association’s purpose may be achieved, without limitations, through :

- Outsourcing the design and operation of the national system to one reputable ICT service provider – chosen among the 3 preselected IT providers,

- 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: the regular operation of the System,

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 System


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that shall be objective and transparent and open to any party duly authorised to operate in the legal supply chain,

- Governing the National System on the behalf of the national stakeholders,

- Managing the IT, contractual and human interfaces between the EMVS and BeMVS;

- 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,

- Concluding and administering user agreements and related fee and payment arrangements,

- 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 multi-party 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.

147. The BeMVO shall be authorised to carry out all activities that directly or indirectly relate to the realisation of its remit. To this purpose, it will be authorised in the governing Statutes to buy, sell or rent all real estate

and installations, take a mortgage on such goods, employ relevant personnel and hire contractors as required.

148. The BeMVO can choose to outsource activities with regard to the above responsibilities to the EMVO or IT service provider under a service level agreement.

Constituencies

149. 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.


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150. The stakeholder constituencies, representing material users of the EMVS are:

- The research based pharmaceutical companies, - The generic pharmaceutical companies, - The pharmaceutical parallel distributors

Above constituencies are obliged to be part of the BeMVO

- The self-medication pharmaceutical companies, - The full-line pharmaceutical wholesalers,

- The community pharmacies, - The hospital pharmacies.

These constituencies have the choice to become member.

Members

151. Representative federations are entitled to full membership of the BeMVO

152. The BeMVO is composed of Full Members and Non-Voting Members

Full Membership

153. The parties agree to start with 8 Full Members representing the seven constituencies. They are the founding full members

154. These Full Members are - alphabetic order

- ABPH-BVZA, - ANGR-NVGV - APB, - BACHI - BAPI,

- FEBELGEN, - OPHACO, - PHARMA.BE

155. Although many Full Members cover activities covered by different constituencies, all Full Members have to decide to whixh constituency they belong to.

156. Other association can be admitted as Full Member at a later time.

157. Each full member decides freely about the appointment of the physical persons who will represent him in the General Assembly.


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Admission of new Full Members

158. Admission of new Full Member is open to national associations (cumulative)

- 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)

159. The founding Full Members of each constituency develop – before the creation of the BeMVO - more specific rules and procedures for admission of new Full Members within their constituency.

160. Upon admission of a Full Member it shall be specified which Constituency that Full Member belongs to.

161. The Constituency submits the final proposal for new Full Members within their constituency to the GA for approval.

Rights and obligations of Full Members

162. 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 participate in the Board of Directors (as Director of Deputy Director)

- 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 at their own cost.

- 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


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Assembly or the Board of Directors in accordance with applicable laws and regulations.

Membership Fees

163. Each Full Member will be liable to pay a fixed equal annual fee to contribute to the governance costs of the BeVMO

164. 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.

165. The fee level can be revised by the General Assembly on a recommendation of the Board of Directors.

166. The fixed equal annual fee – per constituency - is set at 5.000,00 euro.

167. 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.

168. 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 trigger a suspension of voting rights of the Full Member and/or its Constituency until such time as fees are settled in full.

Affiliate Membership

169. Affiliate Members are parties admitted as such.

Admission of Affiliates Members

170. 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


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- Wholesalers and persons authorised or entitled to supply medical products to the public.

171. Candidate new Affiliate Members submit their request for Affiliate Membership towards the administration of the BeMVO. The Board of Directors will take decision on admission after consultation and agreement of the related Constituency

Rights and obligations of Affiliate Members

172. The statutes will attribute the following rights and obligations to the

Affiliate Members:

- The right to receive notice of all General Assembly's meetings - The right to attend General Assembly 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 Board of Directors.

- The obligation to pay a yearly affiliate membership fee as may be foreseen pursuant to above paragraph 156;

- The obligation to act in compliance with the Statutes; and - Any other right or obligation set out in the Internal Regulations or

may be decided by the General Assembly or the Board of Directors. Such rights and obligations may differ for each category of Affiliate Membership.

173. Affiliate members do not incur any personal liability for commitments of the association.

174. Other than as set out above, 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.

Membership Fees

175. The membership fee for affiliate members is equal to all and is set at 500 euro per year.

176. The General Assembly may review the level of annual fee for Affiliate Members on a recommendation of the Board of Directors.


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Resignation - Suspension - Exclusion - Procedure of withdrawal of membership rights

177. 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.

178. In case of forced or voluntary dissolution, or insolvency, bankruptcy, cessation of operations and similar events of a member, membership shall be deemed to be terminated upon notification by the Chair of the Board of Directors, or his delegate to that member.

179. 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 member can at any time be excluded by resolution of the General Assembly requiring a majority vote of two thirds of the Constituencies represented by the Full Members present or represented.

180. 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 defence before the relevant meeting before the resolution is voted upon.

181. Any decision to exclude has immediate effect, unless otherwise resolved by the General Assembly.

182. Should any Full Member, once admitted, fail to satisfy the full membership criteria (set out in this document or set out by the governance rules within the concerned constituency), they shall be entitled to maintain full membership rights till the end of the fiscal year. If the criteria remain unfulfilled at the end of the fiscal year.

183. Any disputes as to whether the membership criteria continue to be fulfilled, shall be adjudicated on by an independent third party auditor to be appointed by the Board of Directors.

184. 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.


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Governance of the BeMVO

The General Assembly

The General Assembly - Composition.

185. The General Assembly is composed of all Full Members.

186. The Affiliate Members and representatives of the national relevant competent authorities can attend such meetings in an observer capacity.

187. The Board of Directors may agree to admit other external observers to the General Assembly.

The General Assembly – Powers and decisions

188. The General Assembly shall have full powers to determine the overall policies, objectives, procedures, methods and courses of action required to achieve the remit of the BeMVO.

189. The General Assembly shall determine which decisions may be delegated to the Board. It shall review annually, as an agenda item and based on a report of the Board, the adequacy of the BeMVO structure, and resources available, in light of its objectives.

190. Decisions at General Assembly meetings shall include:

- Approval of the annual budget and the annual accounts, - The raise of the membership fees - All changes to the agree principles on data access - Decide on change of IT provider - Amendment of the Statutes, - Appointment and dismissal of a Chairperson, a Vice Chair and a

Treasurer on a proposal of the Board of Directors, - Approval of new members of the BoD - Acquittal of BoD - Appointment and dismissal of a Statutory Auditor, if any - The admission of new members and the revocation of membership

rights in accordance with the agreed procedures - The timing and manner of effecting the dissolution and liquidation

of the BeMVO.

The General Assembly - Convocation

191. The General Assembly shall meet in ordinary session once a year.


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192. Extraordinary General Assemblies can be convened at the request of a minimum of two Full Members representing different Constituencies.

193. The convocation notice shall include the agenda, date, time and place of the meeting. The convocation notice must be sent by letter, e-mail or any other communication device which produces a written document, at least thirty days prior to the meeting, unless in exceptional urgent cases which shall be set out in writing by the Chair, in which case the notice period is reduced to eight days.

The General Assembly - Place

194. The meetings are held at the registered office of the association or at any other place indicated in the convocation notice.

195. As an alternative to the Extraordinary General Assemblies, the Full Members may unanimously adopt written resolutions. (see item ‘majorities’)

The General Assembly Meeting- Chair

196. 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.

The General Assembly Meeting - Agenda

197. 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 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.

The General Assembly Meeting - Attendance Quorum.

198. The General Assembly can validly deliberate and resolve if a two-thirds majority of the Constituencies that are represented by one of more Full Members, are present or represented by written proxy at the meeting.

199. Each Constituency shall make known the identity of its representative empowered to vote at the General Assembly at least five days prior to each General Assembly.


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200. 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

The General Assembly Meeting- Voting rights

201. Subject to the qualification in the following paragraph, each Full Member shall have one vote in the General Assembly.

202. 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 who shall represent that Constituency at voting and the voting instructions for such person. Absent a written agreement between all Full Members of a Constituency as to who will exercise their vote and how, the Full Members representing such Constituency shall not be able to vote.

203. In order to vote at the General Assembly meetings, each of the Full Members of each Constituency must, at least five business days prior to the meeting, inform the Chair of the Board of Directors, in writing (including e-mail), of its intention to attend the meeting indicating the name and capacity of the person authorised to vote on behalf of that Full Member. Every Full Member entitled to vote has the right to grant to any individual authorised to represent another Full Member, by 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.

The General Assembly Meeting- Majorities

204. Decisions at General Assembly meetings shall be adopted by at least two-thirds of the votes cast on behalf of the Constituencies represented by the Full Members

205. Failure to vote shall be considered as an abstention. Invalid, blank votes and abstentions are not taken into account for the calculation of the majorities.

206. The Full Members can unanimously adopt written resolutions in respect of all matters that fall within the powers of the General Assembly meeting. Resolutions adopted pursuant to this procedure shall be sent to each of the Affiliate Members within ten working days from their adoption.


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The General Assembly Meeting- Veto rights

207. Each 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 community of more than 10.000 euro.

208. The BoD will do the calculation of the above impact.

209. All Constituencies have a veto right in the GA in the following domains

- Membership fees are raised by more than 15%

- In case of changes to the agreed principles on data access and management, provided these changes concern the respective Members own data and are not against the legal rights of public authority to have access to data.

210. 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 in the case each Full Member is represented in person, or by a proxy (according to national law).

211. The Full Members of a Constituency shall, if requested by any of its Full Members, 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, the Full Members of such Constituency shall not be able to use their veto right.

General Assembly Meeting - Minutes of the meeting

212. 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 and shall be formally approved at the next General Assembly meeting.

213. The minutes – with the exception of those that must be enacted in a notarial deed – 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.

214. Full Members and Affiliated Members can consult the minutes at the registered office or receive a copy.


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215. 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.

The Board of Directors

The Board of Directors – Composition

216. Subject to the qualification in the following paragraph, each Founding Full Member shall appoint one Director to the Board of Directors.

217. In the event that a Constituency is formed by more than one Founding Full Member, the Founding Full Members of such Constituency shall appoint a Director in the Board of Directors and a Deputy Director. The Founding Full members of that constituency will decide on the governance rules within the constituency e.g. process to appoint the Director and the Deputy Director

218. The Deputy Directors can participate in the meetings of the Board of Directors with an advisory function only. In absence of the Director the Deputy Director will represent the Constituency and will automatically take over the voting right of the absent Director.

219. The GA has to approve the new members of the BOD; eventually in an extra ordinary GA.

220. Non-Founding Full Members can appoint a ‘Board Observer’.

221. Such Board Observers can participate in the meetings of the Board of Directors with an advisory function only.

222. The Founding Full Members of a Constituency can, by unanimity, decide to appoint a Director in the Board of Directors representing a Non

Founding Full Member.

223. The national competent authority has the right to participate as a Board Observer. This Board Observer cannot be dismissed by the General Assembly.

224. The mandate of the Board of Directors members shall be two years. The mandate is renewable unlimited times for subsequent periods of two years

225. The mandate of the members of the Board of Directors is not remunerated. Attendance fees are not foreseen, nor the reimbursement of costs.


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226. If a legal entity is appointed as Director, it must appoint a representative physical person who shall exercise the mandate as Director of BeMVO.

227. The Directors do not, in the framework of their function, contract any personal obligation and are not responsible, except vis-à-vis the association for the performance of their mandate.

228. The Directors have a duty of stewardship toward the common interests of the members.

The Board of Directors – End of mandate and Vacancy

229. The mandate of a Director ends by: - Voluntary resignation, upon prior notice of thirty days to be notified

in writing to the Board of Directors; - Expiration of the term of the mandate; - Death; - 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 or the appointing Constituency.

230. Each Director, Deputy Director or Board Observer can be dismissed by the Full Member(s) representing the Constituency who appointed such Director or Board Observer at any time without cause or at any time by the General Assembly.

231. When the mandate of a director becomes vacant, the Full Members of the relevant Constituency have the right to fill the vacancy. The newly appointed Director shall – after approval of the GA - continue the term of

the mandate of the director he replaces.

The Board of Directors – The Chair

232. The Chair of the Board of Directors is attributed to one of the Directors of the Board representing one of the MarketingAH Constituencies.

233. The proposal has to be accepted by the GA by 2/3 majority.

The Board of Directors - Decision power – Delegation - Daily management

234. The Board of Directors shall ensure that the BeMVO operates in compliance will all relevant laws and the governing Statutes. The Board


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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 MOU

- To make recommendations to the General Assembly as to the allocation of service fees to be charged to Manufacturing and/or Marketing Authorisation Holders for the use of the National Systems.

- 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") having obtained the approval of the General Assembly to delegate or appoint such person,

- 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

BeMVS performance issues, incident management, operational changes, configuration management, and data access security and to report on such issues to the General Assembly, 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, maintenance and development of the BeMVS,

- To make written and duly reasoned recommendations to the General Assembly as to the admission of new members and the termination of membership as it considers appropriate.


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235. The Board of Directors has the power to establish and dissolve any committees and to determine their composition, remuneration and work method.

236. 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.

The Board of Directors Meetings - Convocation

237. 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.

238. The convocation notice shall include the agenda, date, time and place of the meeting.

239. The convocation notice must be sent by letter, e-mail or any other communication device which produces a written document, at least 15 days prior to the meeting, unless in exceptional urgent cases 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.

The Board of Directors Meetings - Place

240. The meetings are held at the registered office of the association or at any other place indicated in the convocation notice.

241. The meeting of the Board of Directors can be held by conference call or videoconference provided that the resolutions taken at such conference call or videoconference are subsequently recorded in minutes.

The Board of Directors Meetings - Chair

242. 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.

The Board of Directors – Attendance Quorum

243. The Board of Directors shall validly meet and deliberate when at least the ½ +1 of the Directors are present in person or represented by written proxy.


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244. 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.

The Board of Directors Meeting – Voting rights

245. Each director of the BoD has one vote. In case a constituency has also a deputy director and the director of that constituency is absent in the meeting, the deputy director has the right to vote.

The Board of Directors Meeting – Majorities

246. All decisions shall require a 2/3 majority of the votes of the Directors present at a Board of Directors' meeting or validly represented.

247. Failure to vote shall be considered as an abstention.

248. Every Director – in case the Constituency has no deputy director - has the right to grant any other Director or other representative of the same Constituency, 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.

249. The Directors can, by unanimous vote, adopt written resolutions in respect of all resolutions that fall within the powers of the Board of Directors. The Chair shall promptly afterwards send a copy to the Observers.

The Board of Directors - Minutes of the meeting

250. With the exception of the written resolutions adopted pursuant to paragraph above, 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.

251. 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.

252. Directors and Board Observers can consult the minutes at the registered office or receive a copy.

253. 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.


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Chair, Vice-chair and Treasurer

254. The BeMVO shall have as officers a Chair, Vice Chair and Treasurer.

255. The Chair and Vice Chair shall ensure that the Board of Directors is effective in its tasks of setting and implementing strategy. They will preside over meetings of the Board of Directors and the General Assembly and carry out the policies and instructions of both. Their main responsibilities 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. -

Managing Director or General Manager

256. Additionally, one Managing Director or General Manager can be appointed.

257. The Managing Director or General Manager 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-to-day operations of the BeMVO. The Board may specify the matters that belong to daily management in accordance with Article 21.

258. 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.

Representation

(definition to be developed with legal adviser)


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259. 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 1 director from the industry

stakeholders, acting jointly; or - the General Manager(s) or Managing Director(s), acting singly,

within the limits of the delegated daily management powers.

260. No further justification or prior decision of the Board of Directors shall be required in this respect.

Commitments to secure an orderly process of development and roll out of the BeMVS.

261. The introduction of the NMVS is a complex process, whereby a massive number of different stakeholders will be impacted and need to act in a timely manner.

262. All Parties recognize these challenges and agree to set up a dedicated project initiative for their constituency to

- Inform properly and in detail all related stakeholders;

- Investigate in detail the impact for their respective stakeholders;

- Coordinate solutions so all stakeholders can adapt their systems and processes in an effective way at the lowest cost possible;

- Identify all potentially blocking factors (legal, organisation, technical,…) putting the implementation at risk;

- Set up a planning- and follow up system for all activities necessary to realize the implementation within the agreed timeframe.

263. All Parties agree to work closely together with the BeMVO and recognize the BeMVO as the overall program manager for this implementation. In that respect they agree to

- Cooperate and be present on the monthly program management meeting that will be organized by the BeMVO


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- Submit a monthly update of the progress report template – elaborated by the BeMVO