THE ONBOARDING PROCESS TO THE EMVO MUSTKNOWS AND

THE ON-BOARDING PROCESS TO THE EMVO MUST-KNOWS AND TIMELINE FOR A SUCCESSFUL ON-BOARDING Fanny Trenteseaux Commercial & Partner Management Department

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion SKUL WORKSHOP

FMD LEGISLATION AND DELEGATED ACT 2011 2016 July 2011 Publication of FMD • • 10. 04. 2018 SKUL WORKSHOP 2017 9 Feb 2016 Publication of Delegated Regulation 2018 36 Mon. Connect approx. 2, 291 companies to the EMVS Establish National Systems in 32 countries Connect many thousand Pharmacies and Wholesalers Serialise all affected pharmaceutical packs (10. 5 bn) 2019 9 Feb 2019 Mandatory verification of all packs in scope

RESPONSIBILITIES OF THE SUPPLY CHAIN PARTNERS 10. 04. 2018 SKUL WORKSHOP

SYSTEM LANDSCAPE 10. 04. 2018 SKUL WORKSHOP

EMVO MEMBERS Pharmacies Wholesalers Hospitals Parallel Distributors Research Based Industry Generics Industry 10. 04. 2018 SKUL WORKSHOP

SYSTEM COSTS 10. 04. 2018 SKUL WORKSHOP • Participation Agreement • One-time On-boarding Fee (table) • Contracting partner : OBP NMVO Contracting EMVO On-boarding EMVO ON-BOARDING / NMVO CONTRACTING • Contract in • Annual fee model) • Contracting partner : MAH place (flat

CURRENT SITUATION 656 OBPs on the EMVO Portal 10. 04. 2018 SKUL WORKSHOP 545 Participation Agreements Signed 13 Connection in PRD

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion 10. 04. 2018 SKUL WORKSHOP

WHAT IS AN “OBP”? o OBP means On-Boarding Partner. The OBP is the contracting party of EMVO; it concludes the Participation Agreement (PA). o The OBP represents the Marketing Authorization Holders (MAH) it 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 MAHs. o The OBP has to be affiliated (*) to a MAH/a group of MAHs o The OBP can only upload product data for affiliated manufacturers as long the marketing authorization of such products lie 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). SKUL WORKSHOP

EMVO THE ROLE AMONG A CORPORATION EU Hub PA with EMVO “Company A” EXAMPLE 1 (Manufacturing & Marketing Authorization Holder) = On-boarding Partner (OBP) Product AS 3 SKUL WORKSHOP Product AS 2 Product AS 1 10. 04. 2018

EMVO EXAMPLE 2 EU Hub PA with EMVO “Company A” – European headquarter = OBP (On-boarding Partner) Affiliated Manufacturing & Marketing Authorization Holder “Company A -ES” “Company A -NL” “Company A -AT” Product AT 1 Product NL 2 Product NL 1 Product ES 3 SKUL WORKSHOP Affiliated Manufacturing & Marketing Authorization Holder Product ES 2 Product ES 1 10. 04. 2018 Affiliated Manufacturing & Marketing Authorization Holder

EMVO EXAMPLE 3 EU Hub Product DE 1 Product DE 2 PA with EMVO Product NL 3 Product NL 1 Product FR 2 PA with EMVO Product NL 2 “Company A” – European headquarter “Company B”- European headquarter = On-boarding Partner (OBP) Affiliated Manufacturing & Marketing Authorization Holder Affiliated Marketing Authorization Holder “Company A -FR” “Company A -DE” Affiliated Manufacturing Authorization Holder “Company A -AT” Affiliated Marketing & Manufacturing Authorization Holder Affiliated Marketing Authorization Holder Company AAT acts as CMO for Com pany B -NL “Company B-NL” “Company B -AT” Product AT 1 Product NL 3 Product NL 2 Product NL 1 Product FR 2 Product FR 1 Product DE 3 Product DE 2 Product DE 1 The marketing authorisation holder (MAH) is legally responsible for the quality, efficacy and safety throughout the entire life cycle of the product. Activities may be delegated but overall responsibility is retained by the MAH. 10. 04. 2018 SKUL WORKSHOP

CMO CONNECTION 10. 04. 2018 SKUL WORKSHOP

MASTER DATA – DATA FLOW Master Data are considered as the set of data elements associated with a specific product record and contain the elements of information about the product that do not belong to a specific batch. Can be static or Market Specific. 10. 04. 2018 SKUL WORKSHOP

MASTER DATA o Detailed information available on EMVO Website : EMVS Master Data Guide & Coding requirements General Requirements Master Data Elements ( DR 2016/161) ü common ü market ‘applies to all markets’ collection of data specific collection of data 1. Common Master Data Elements (Product Code, Coding Sheme, Name, Strength, Pack Type, . . ) 2. Market Specific Master Data Elements (ISO Code, National Code, MAH ID, . . ) Ø One off or occasionally uploaded function Ø Procedure: SMP = 1 x CMDE + 1 x MSMDE; MMP = 1 x CMDE + MSMD for each market 10. 04. 2018 SKUL WORKSHOP

MASTER DATA 10. 04. 2018 SKUL WORKSHOP

BATCH DATA – DATA FLOW Batch Data are the data that provides the link between the pack data and the Product Master Data 10. 04. 2018 SKUL WORKSHOP

PACK DATA – DATA FLOW Pack Data essentially describes the serial numbers of each pack and the batch to which the packs belong 10. 04. 2018 SKUL WORKSHOP

SKUL WORKSHOP OBP A OBP’s System a Gateway Provider X OBP B OBP’s System b OBP C Gateway Connection OBP B Gateway Connection OBP A Gateway Connection OBP C Hub Connection OBP B Hub Connection OBP A Hub Connection 2 OBP A Hub Connection 1 CONNECTION TYPES EU Hub Gateway Provider Y OBP C OBP’s System c

HOW TO SPEED UP THE PROCESS RIGHT FROM THE START? Collect Information: 1. Visit EMVO Download Section https: //emvo-medicines. eu/downloads/ 2. Consult our training videos: • OBP Check-list for contractual On-boarding • The On-boarding Partner Portal 1. Visit EMVO Knowledge Data Base https: //emvo-medicines. eu/faq/ • Who will be the On-Boarding Partner? • What is my Company Registration number and VAT number? • Who can and will be the Authorized Representative? • Who can and will be the Single Point of Contact? • How many MAHs does the OBP represent? • And many more… 10. 04. 2018 SKUL WORKSHOP

HOW DOES THE ON-BOARDING WORK? https: //emvo-medicines. eu/pharmaceutical-companies/obp-portal/ 10. 04. 2018 SKUL WORKSHOP

STEP 1: PROVIDE INITIAL INFORMATION Trigger step 1: Successful Request to Participate To add or modify the requested information Estimated time to complete Status: Not Started In Progress Complete 10. 04. 2018 SKUL WORKSHOP

1. 1 COMPANY INFORMATION 10. 04. 2018 SKUL WORKSHOP

FREQUENTLY COMMITTED ERRORS o Company name make sure to provide the full official name of your company o Individuals’ name make sure to provide the full name of the person, as it appears in the national register o Company identification numbers : VAT and Company registration number make sure not to get confused between the OBP company, the parent company, and the MAHs information. make sure to include the full sequence of digits, no typo, and the initial country identification in front, if necessary Company Type: o Parallel Distributor - decommisionning and upload of data of new data related to repacked products Original Pack Manufacturer – upload of initial pack data • • ! The type of connection in the Hub is different for each of them ! 10. 04. 2018 SKUL WORKSHOP

1. 2 AUTHORISED REPRESENTATIVE Action: A prefilled NDA will be generated Mandatory in order to proceed with the further steps 10. 04. 2018 SKUL WORKSHOP Note : The Authorised Representative (AR) is the person authorised to sign on behalf of the company. The AR will sign the Non-Disclosure Agreement and the Participation Agreement.

FREQUENTLY COMMITTED ERRORS Copy of proof of the Authorised Representative Purpose: check the authorisation of your named Authorised Representative to sign on behalf of the company an official register – a notary certificate – a CEO Letter the AR expressly named together with his/her autorisation and/or his/her position among the senior management validity of the document with respect to a potential expiration date 10. 04. 2018 SKUL WORKSHOP rs e t s i g e R l a n e o t i i t s a b N e f List o le on our w b a l i a v a

STEP 2: DETAILED INFORMATION AND PARTICIPATION AGREEMENT Trigger step 2: Successful Initial Information and Authorised Representative copy of proof Download General Info Pack Status: Not Started Completed View and Download prefilled Participation Agreement (PA) Status: Not Started Awaiting Approval Approved Rejected A sample of the PA is available on our website in its download section. 10. 04. 2018 SKUL WORKSHOP Status: Not Started Completed

2. 2 SINGLE POINT OF CONTACT Note: • The SPOC contact details will be listed in the Participation Agreement. • By signing the PA, the Authorised Representative will confirm the SPOC appointement. • The SPOC will be the responsible for providing all the required information in the OBP Portal. And will be the only person allowed to confirm the information provided. IMPORTANT NOTE : CREDENTIALS When Legitimacy Check is successfully passed, the Assistant will receive individual user credentials to access the portal. The Initial Registration Requester will looses his/her access if he/she is not the same person than the SPOC. 10. 04. 2018 SKUL WORKSHOP

OBP CONTRACT WITH EMVO The Participation Agreement (PA) § Contractual framework for participation in the On-boarding project, e. g. • • § Use of the EMVO Gateway Interface development Connect to the HUB SDK Includes a Non-Disclosure Agreement covering the provision of Confidential Information by EMVO, e. g on • European Hub • EMVO Gateway § 10. 04. 2018 SKUL WORKSHOP Purpose: Execution of Technical On-Boarding he PA t n g i s unter- hen the o c y l will on ack only w cessfully O V M E nd it b will be suc e s d an check sed y c a pas legitim

FREQUENTLY COMMITTED ERRORS Contracts Consistency between the named Authorised Representative in step 1. 2. and the person that actually signed the contracts no ammendments TWO hardcopies have to be sent to EMVO both hardcopies have to be signed by the relevant person both hardcopies have to be original versions (not scanned) 10. 04. 2018 SKUL WORKSHOP the n o s oltip o t e h in t d e n i portal Expla ing d r a o On-b the e h t in d e e on l n i b a a l l i p Ex ava e n i l e ite Guid webs

2. 5 INVOICING INFORMATION Mandatory fields In Number of MAHs the OBP has to chose from a drop-down menu the total number of MAHs it will upload data for in the European Hub. r u o n eo l b a l i ava e l p ite s Sam b e w 10. 04. 2018 SKUL WORKSHOP

ON-BOARDING FEE o One-time on-boarding fee o Fee per OBP o Depending on the number of MAHs the OBP represents and will upload data for in the EU Hub o Depending on the time frame in which the OBP uploads its valid Participation Agreement on the OBP Portal Early Bird From the 15 th of January 2018 From the 15 th of June 2018 OBPs with more than 12 MAHs in Europe 20, 000 € 30, 000 € 45, 000 € OBPs with 6 to 12 MAHs in Europe 10, 000 € 15, 000 € 22, 500 € OBPs with 3 to 5 MAHs in Europe 8, 000 € 12, 000 € 18, 000 € OBPs with 2 MAHs in Europe 6, 000 € 9, 000 € 13, 500 € OBPs with 1 MAH in Europe 3, 000 € 4, 500 € 6, 750 € 10. 04. 2018 SKUL WORKSHOP

2. 7 MAH AND PRODUCT INFORMATION Note 1: • Add MAH allows the OBP to manually add a new MAH into the list. • Import allows the OBP to upload an excel sheet with all its MAHs listed 10. 04. 2018 SKUL WORKSHOP Note 2: For the purpose of the Legitimacy Check the OBP has to provide a minimum of one MAH and a minimum of one corresponding product information. In Step 5 - Maintenance, the OBP will have to fill-in the whole list of MAHs for which it will upload data in the European Hub.

2. 7 MAH AND PRODUCT INFORMATION Note: Product information; • The Marketing Authorisation Number is the licensed number related to the number of the product that the MAH received when applying for Marketing Authorisation • The Marketing Authorisation Name; together with the name, please mention the strength and the pack size of the product in order to allow EMVO to identify the exact product presentation linked to the Marketing Autorisation Number. • The Marketing Authorisation Registration refers to the country covered by the marketing authorization and may be centralized. 10. 04. 2018 SKUL WORKSHOP

2. 8 CONFIRM ALL INPUTTED INFORMATION By clicking on the Confirm button the SPOC confirms the accuracy of the information provided on the portal. This triggers the Legitimacy Check. 10. 04. 2018 SKUL WORKSHOP

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion 10. 04. 2018 SKUL WORKSHOP

STEP 3: APPROVALS Trigger step 3: Step 2 completed and confirm button pressed. Status: Not Started Passed Failed Status: Not Started Awaiting hardcopy Sent back on xx: xxxx Status: No Status Awaiting payment Payment received 10. 04. 2018 SKUL WORKSHOP

LEGITIMACY CHECK o Triggered when the SPOC confirms the accuracy of the information provided on the portal o Around 50 parameters checked o Direct and indirect checks are conducted o Outsourced: conducted totally independently from EMVO – ensuring efficiency, accuracy and objectivity o The check is conducted by actual people – ensuring a solutionoriented and reflexive approach 10. 04. 2018 SKUL WORKSHOP

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion 10. 04. 2018 SKUL WORKSHOP

EU HUB ENVIRONMENTS ITE environment • Integrated Test Environment • Used as sandbox by multiple OBP’s • Integration testing of OBP’s connection 10. 04. 2018 SKUL WORKSHOP IQE environment • Integrated Quality Environment • Used for Quality- & Certification testing by multiple OBP’s • Validated environment PRD environment • Productive Environment • Validated environment IQE: Integration Quality Environment PRD: Productive Environment

STEP 4: TECHNICAL ON-BOARDING Trigger step 4: • Step 3 completed Note: If you make use of a Gateway Connection, step 4. 2. 2 (ITE) is optional Status: Not Started Completed Status: Not started Completed Access sub-steps 10. 04. 2018 SKUL WORKSHOP

4. 1 TECHNICAL INFO PACK The Technical Info Pack contains the following information in their last available versions: Documentation. NET 1. • • • . Net Callback Service. Net Hub 2. 2 SDK EMVS 0794 - EMVS OBPs. NET SDK Installation Guide Documentation JAVA 2. • • EMVS 0787 - EMVS Java SDK Installation Instructions For OBPs EMVS Java SDK EMVO Gateway 3. • EMVO_0038_EMVO Gateway User Manual On Boarding Steps 4. • • EMVO_0077_OBP On-boarding Guideline EMVO_0086_OBP On-Boarding Presentation EMVO_0117_Creating CSR Files EMVS 0714 - EMVS SDK for OBPs 10. 04. 2018 SKUL WORKSHOP

4. 2. 1 CONNECTION DETAILS Note: This step is pre filled if you completed step 1. 3 Drop-down menu listing the Registered * Gateway Providers. Making use of a Registered Gateway Provider allows the OBP to start immediately a self -certification test in the Integrated Quality Environment (IQE). * Registered Gateway Provider is a provider which signed the License Agreement with EMVO and a Support Contract with Solid. Soft. 10. 04. 2018 SKUL WORKSHOP

4. 2. 2 ITE Note: For Gateway Connections, step 4. 2. 2 (ITE) is optional - Organisation name Company Type Organization ID Client ID Upload the generated CSR file corresponding with information provided on step 4. 2. 2. 1 Status: Not required No Status Failed Available Status: Not required No Status Failed Complete Download Client and Hub Certificates to have access to ITE. Check Service Endpoints 10. 04. 2018 SKUL WORKSHOP Optional: Check Test Results of your transactions to the EU Hub After completing Step 4. 2. 2. 3 a Session Token request will automatically be triggered. Status: Not required No Status Failed Available Downloaded on xx: xxxx

4. 2. 3 IQE Note: When the OBP is confident that its interface is ready for testing, (s)he can start testing in IQE Info button will display the current Session Token Review your transactions with the EU Hub and results Submission 10. 04. 2018 SKUL WORKSHOP

4. 2. 2. 5 IQE - TEST STATUS METRICS Note 1: s e n i l e Ba st e T The OBP should verify and submit the Test Results of all positive transactions which are sent to the EU Hub in the last 30 minutes and will cover the basic requirements : 3 test metrics forming the baseline test; - Upload Product Master Data - Upload Product Pack Data - Update Product Pack Data When the 3 test forming the baseline test are passed , OBP should click the Submit button. Note 2: By default all status are marked as failed. After passing and submitting the baseline test results, status will still reset to failed after 30 minutes. Please await as EMVO manually approves your results. 10. 04. 2018 SKUL WORKSHOP

4. 2. 4 PRD Note: A baseline test is a prerequisite to access PRD. 10. 04. 2018 SKUL WORKSHOP

4. 3 CONNECTION 2 Optional: This step can be used in case the OBP wants to develop a second connection to the EU Hub. Repeat previous steps. 10. 04. 2018 SKUL WORKSHOP

5. MAINTENANCE 10. 04. 2018 SKUL WORKSHOP

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion 10. 04. 2018 SKUL WORKSHOP

NMVO CONTACT DETAILS 10. 04. 2018 SKUL WORKSHOP

NMVO ON-BOARDING • • • Tracked by a planning and close follow-up Estimated connection dates (PRD) to be communicated on EMVO website AU, BE, BG, CZ, DK, FI, FR, IS, IE, LT, NO, SK, SI, SE have passed their Assessment Part 1 EE, LV, NL, ES, UK are on-going HR, PT are scheduled All others haven’t started LEGAL PROGRESS 10. 04. 2018 SKUL WORKSHOP TECHNICAL/QA READINESS

CONTENT FMD Implementation in Europe Contractual On-boarding Process Approvals Technical On-boarding Process NMVOs System Readiness Conclusion 10. 04. 2018 SKUL WORKSHOP

ORGANISATIONAL CHART EMVO Board of Directors President: Hugh Pullen (EFPIA) Vice-President: Sonia Ruiz Morán (PGEU) Treasurer: Richard Freudenberg (EAEPC) Monika Derecque-Pois (GIRP) Adrian van den Hoven (Medicines for Europe) General Management Andreas Walter Commercial & Partner Management Markus Gerigk (external consultant) 10. 04. 2018 SKUL WORKSHOP Koen Van Gompel Tobias Beer Fanny Trenteseaux Maureen Pollart (intern) Operations Emmanouela Nikolakopoulou Léa Auriol (intern) Jannik Jäger (intern) André Geraldes João Pacheco Nikolai Lehmann (intern) Willem Theunissen (external consultant) Paul Mills (external consultant) Office Management Quality Assurance Marisa Jimenez Sanchez Stephan Theunissen Besiki Papunashvili (intern) Annette Aragones

EMVO CONTACT DETAILS Helpdesk: +372 611 90 44 Mail: helpdesk@emvo-medicines. eu Web-page: https: //emvo-medicines. eu/ 10. 04. 2018 SKUL WORKSHOP