EMVO 0086 OBP On-Boarding Presentation

1 EMVO ON-BOARDINGHOW TO CONNECT TO THE EU HUB?VERSION DECEMBER check the latest version of this Presentation and the On-Boarding Guideline. DISCLAIMER2 EMVO 0086 OBP On-Boarding Presentation (withoutparalleldistributionactivity)and ParallelDistributors(MAHwithparalleldist ributionactivity)andtherelatedPower-Poin tpresentation(the"Guides")areprovided"AS IS" ,including,butnotlimitedto, ,EMVO expresslydisclaimsallwarrantiesofanykind ,whetherexpressedorimplied,including,but notlimitedtothewarrantiesforhiddenorlate ntdefect,ofmerchantability, ,lossorclaims,includinglossofuse,data,pr ofits,benefits,data,business,opportunity ,goodwill,clientele,forthirdparty sclaims,orforanyotherindirect,special,in cidentalorconsequentialdamagesofanykindi nconnectionwithorarisingoutoftheuseofany informationdisclosedhereunder,whetherall egedasabreachofcontract(includinggravefa ult),tort,negligence(includinggrossnegli gence)

2 ,hidden/latentdefects,strictliabilityora nyotherlegaltheory, ,however, partner PORTAL3 EMVO 0086 OBP On-Boarding Presentation InformationHow does the On-Boarding work?14/12/2017ON- boarding partner PORTAL4 EMVO 0086 OBP On-Boarding Presentation InformationHow does the On-Boarding work?14/12/2017 FMD LEGISLATION AND DELEGATED ACT5 EMVO 0086 OBP On-Boarding Presentation Feb 2019 Mandatory verification of all packs in scope9 Feb 2016 Publication of Delegated RegulationJuly 2011 Publication of FMD36 Mon20192016 Connect approx. 2,500 On-Boarding Partners (OBPs) to the EU Hub Establish National Systems in 32 countries Connect many thousand Pharmacies and Wholesalers Serialise all affected pharmaceutical packs ( bn)~ 474 days remainFMD:Falsified Medicines Directive 2017201814/12/2017 RESPONSIBILITIES OF THE SUPPLY CHAIN PARTNERS6 EMVO 0086 OBP On-Boarding Presentation by MAHRisk based verification by WholesalersVerification and check-out at point of dispenseSafety features:Code ( unique identifier )+Tamper evidenceSystem set up and Governance by MAH together with other stakeholders Oversight by competent authoritiesNMVSP roduct #:09876543210982S/N:12345 AZRQF1234567890 Batch:A1C2E3G4I5 Expiry.

3 140531 HUB14/12/2017 EMVO MEMBERS7 EMVO 0086 OBP On-Boarding Presentation Based IndustryGenerics IndustryParallel DistributorsWholesalers14/12/2017 ORGANISATIONALCHARTEMVO 0086 OBP On-Boarding Presentation Management Andreas WalterCommercial & partner Management Tobias BeerFanny TrenteseauxL a Auriol (Intern)Andr GeraldesKirsi Kulmakorpi (Intern)Emmanouela Nikolakopoulou(Legal Counsel)Jannik J ger (Intern)Operations Koen Van GompelPaul Mills (External Consultant)Willem Theunissen (External Consultant)Office Management Marisa Jimenez SanchezQuality Assurance Stephan TheunissenMarkus Gerigk (External Consultant)EMVO Board of DirectorsPresident: Hugh Pullen (EFPIA)Vice-President: Sonia Ruiz Mor n (PGEU)Treasurer: Richard Freudenberg (EAEPC)Monika Derecque-Pois (GIRP)Adrian van den Hoven (Medicines for Europe)SYSTEM LANDSCAPE9 EMVO 0086 OBP On-Boarding Presentation LANDSCAPE II10 EMVO 0086 OBP On-Boarding Presentation : On-Boarding PartnerNMVS: National Medicines Verification SystemNMVO:National Medicines Verification OrganizationWHAT IS AN OBP ?

4 11 EMVO 0086 OBP On-Boarding Presentation means On-Boarding partner . The OBP is the contracting party of EMVO; it concludes the Participation Agreement (PA).oThe OBP represents the Marketing Authorization Holders (MAH) on behalf of whichit will upload data for in the European Hub. It has therefore to be legally authorized to conclude contracts on behalf of a MAH/a group of OBP has to be affiliated (*) to the MAH(s) on behalf of which it will upload data in the European OBP should be located in the European Economic OBP can only upload product data for: its affiliated MAHs a manufacturer as long as the marketing authorization of the related products lies within the OBP corporation.(*) Affiliate shall mean, in relation to a Party, any other person affiliated with such Party within the meaning of Article 11 of the Belgian Code of Companies (it being understood, for the avoidance of doubt, that the definition set out in said Article 11 is agreed to also apply to non-Belgian persons).

5 14/12/2017 Company A (Manufacturing & Marketing Authorization Holder) = On-Boarding partner (OBP)Product AS1 Product AS2 Product AS3 EMVOEU HubEMVO 0086 OBP On-Boarding Presentation with EMVO1214/12/2017 EXAMPLE 1 Company A European headquarter= OBP ( On-Boarding partner )Affiliated Manufacturing & MarketingAuthorization Holder Company A -ES Product ES1 Product ES2 Product ES3 Affiliated Manufacturing & MarketingAuthorization Holder Company A -NL Product NL1 Product NL2 Affiliated Manufacturing & MarketingAuthorization Holder Company A -AT Product AT1 EMVOEU HubPA with EMVO13 EMVO 0086 OBP On-Boarding Presentation 2 Company B -European headquarter= On-Boarding partner (OBP)Affiliated MarketingAuthorization Holder Company B-NL Product NL1 Product NL2 Product NL3 Affiliated Marketing & Manufacturing Authorization Holder Company B -AT Product AT1 Company A European headquarter= On-Boarding partner (OBP)Affiliated Manufacturing & Marketing Authorization Holder Company A -DE Product DE1 Product DE2 Product DE3 Affiliated MarketingAuthorization Holder Company A -FR Product FR1 Product FR2 Affiliated ManufacturingAuthorization Holder Company A -AT EMVOEU HubPA with EMVOPA with EMVO14 The marketing authorisationholder (MAH) is legally responsible for the quality, efficacy and safety throughout the entire life cycle of the product.

6 Activities may be delegated but overall responsibility is retained by the 0086 OBP On-Boarding Presentation 3 WHAT IS AN OBP GATEWAY PROVIDER?15 EMVO 0086 OBP On-Boarding Presentation third-party contractor engaged by the OBP, who assists the OBP entirely or partially with the development, the implementation, the provision, the use, and/or the operational phase related to the OBP interface to the EU Hub via a Gateway Connection,oEvery OBP Gateway Provider has to be promoted by at least one OBP in the On-Boarding Process, oEMVO has then to validate and approve the proposed Gateway Provider, if all requirements are CONTRACT LANDSCAPE16 EMVO 0086 OBP On-Boarding Presentation CPSolidsoftFrame ContractHUBS ervice ContractSupport ContractParticipation AgreementEMVO:European Medicines Verification OrganizationSolidsoft:IT Service Provider for implementation and operation of European HUBOBP: On-Boarding PartnerOBP CP.

7 IT Service Provider -Gateway connection -Direct connection14/12/2017ON- boarding PROCESS17 EMVO 0086 OBP On-Boarding Presentation ) Participation Request Collect information Initial Contact Portal registration2) Contractual Onboarding Company Information Single Point of Contact (SPOC) Invoicing Information Participation Agreement (PA)3) Legitimacy Check Legitimacy check of organizations and person responsible Multi-stage procedure EMVO received Payment4) Technical On-Boarding System Connection System Testing System OperationManaged and administered by EMVO s Commercial & partner ManagementTeamManaged by EMVO s Operations Team14/12/2017ON- boarding partner PORTAL18 EMVO 0086 OBP On-Boarding Presentation InformationHow does the On-Boarding work?14/12/2017 OBP PORTAL19 EMVO 0086 OBP On-Boarding Presentation EMVO sresponsetimeStartingpoint/ triggerfor legitimacycheckPrerequisitetoon-board > MAHs/Parallel Distributors14/12/2017 HOW DOES THE On-Boarding WORK?

8 20 EMVO 0086 OBP On-Boarding Presentation partner Portal(Support software to guide theOBPsthroughtherequirementstoconnectto the EU Hub)14/12/2017 HOW TO SPEED UP THE PROCESS RIGHT FROM THE START?21 EMVO 0086 OBP On-Boarding Presentation EMVO Download Section EMVO Knowledge Data Base will be the On-Boarding partner ? is my Company Registration number and VAT number? can and will be the Authorized Representative? can and will be the Single Point of Contact? many MAHsdoes the OBP represent?14/12/2017 HOW TO REQUEST TO PARTICIPATE22 EMVO 0086 OBP On-Boarding Presentation Via website link2. Fill in User + Company details3. You ll be directed to the confirmation screen4. Check your email to validate your account14/12/2017 HOW TO REQUEST TO PARTICIPATE23 EMVO 0086 OBP On-Boarding Presentation Yourcompany portal willbecreated6.

9 Yourcompany portal is created7. Follow theinstructionsin youremail tologin toyourCompany portal8. YourCompany portal is ready toOn board14/12/2017 INITIAL REGISTRATION REQUESTER CREDENTIALS24 EMVO 0086 OBP On-Boarding Presentation NOTE !The SPOC is the only person having the credentials to access the portal. However, in the event the Initial Registration Requester is the same person as the SPOC, s/he will be able to access the portal with the credential received in the first place. 14/12/2017ON- boarding partner PORTAL25 EMVO 0086 OBP On-Boarding Presentation 2: Participation Agreement + Detailed informationStep 3: ApprovalsStep 1: Provide Initial InformationStep 4: Technical On Boarding14/12/2017 STEP 1: PROVIDE INITIAL INFORMATION26 EMVO 0086 OBP On-Boarding Presentation time to completeTo add or modify the requested informationTrigger step 1:Successful Request to ParticipateStatus: Not StartedIn ProgressComplete14/12 COMPANY INFORMATION 27 EMVO 0086 OBP On-Boarding Presentation makesure to providethe full official nameof yourcompanyCompanyidentification numbers: VAT and Companyregistration number makesure not to getconfusedbetweenthe OBP company, the parent company, and the MAHsinformation.

10 Makesure to includethe full sequenceof digits, no typo, and the initial country identification lettersin front, if necessaryCountry name/ Country of registration makesure to providethe Country name, not the one of the AUTHORISED REPRESENTATIVE28 EMVO 0086 OBP On-Boarding Presentation relatedtothe AuthorisedRepresentativetogetherwitha copy of proofattestingof theauthorisationof thatperson tosignon behalfof thecompany. Note1: The AuthorisedRepresentative (AR) is the person authorisedto sign on behalf of the company. The AR will sign the Participation order toproceedwiththefurtherstepsNote2: A document listingalltheNational Registers in Europe wheretofindtherelevant copy of prooffor yourcompany is availableon ourwebsite in itsdownload of proof of the AuthorisedRepresentativePurpose: check the authorisationof yournamedAuthorisedRepresentative(AR) to signon behalfof the company An official register(pleaseconsultthe National Registerslistfor europeancountries on ourwebsite.)