National Blueprint System Slovakia Kick-Off Meeting

National Blueprint System Slovakia Kick-Off Meeting Bratislava November 22th, 2017 Nov. 22th, 2017 Kick-Off SOOL 1

Agenda Arvato Architecture NMVS Web Service Interface Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 2

Bertelsmann at a Glance 17.0 billion Group revenues 2.6 billion Operating EBITDA 1.1 billion Group profit 116,434 Employees Nov. 22th, 2017 Kick-Off SOOL 3

Arvato A leading international service provider 3,838m Revenues 359m Operating EBITDA 68,463 Employees Service portfolio CRM solutions SCM solutions 170 million online credit checks performed per year more than 1,1 billion parcels delivered a year Financial services IT services Gütersloh Headquarters 600 million customers serviced in customer loyalty systems Runs more than 70 online shops for numerous international fashion brands Nov. 22th, 2017 Kick-Off SOOL 4

Arvato s NMVS Customers Estimating to cover more than 70% of all FMD packs within the EEA by 2019 Agreements and ongoing projects: Nov. 22th, 2017 Kick-Off SOOL 5

Agenda Arvato Architecture NMVS Web Service Interface Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 6

We have to master one central challenge But many stakeholders are involved in the establishment of a NMVS a) Organizer NMVO EMVO b) Primary distributors Marketing authorization holders Contract manufacturers Wholesalers Parallel distributors Public pharmacies Hospital pharmacies c) Software providers Solidsoft (EMVS/EU Hub) Arvato (NMVS) Pharmacy/hospital/wholesaler SW providers/it departments b1) Secondary distributors Army Prisons Airlines Nursing homes Drug treatment centers NGOs... d) Authorities Nov. 22th, 2017 Kick-Off SOOL 7

System Architecture Overview Decentralized integration scenario Pharmacy European Hub (EMVS) Product/ pack data upload National Repository (SOOL) Verification dispense,etc. Pharmacy Multi country requests Wholesaler Pharmacy Product/pack data upload Dispense (Web GUI) Wholesaler Pharmacy MAH MAH MAH Par. Distr. Par. (MAH) Distr. Disp. Doctor Disp. Doctor Disp. Doctor Hospital Pharmacy Legend Digital certificate, issued by Arvato Digital certificate, issued by EMVO Par. Distr. (Wholesaler) Hospital Hospital Legend Local pharmacy software installation, bundles communication with all dispense stations Local hospital software installation, bundles communication with all dispense stations Local wholesaler/par. distr. software installation, bundles communication with all local stations for verification etc. Nov. 22th, 2017 Kick-Off SOOL 8

System Architecture Overview Pharmacy Pharmacy Pharmacy 19 Pharmacy 201 (A) Direct integration pharmacies are only known as pseudonymous codes (including type/version of local software) National Repository (SOOL) Pharmacy Concentrator Pharmacy Pharmacy 19 Pharmacy 201 (B) Concentrator Integration Integration via concentrator, pharmacies are only known by the pharmacy registration code. Legend Local pharmacy software Digital certificate, provided by Arvato Nov. 22th, 2017 Kick-Off SOOL 9

System Architecture Overview Pharmacies: Integration scenarios Data upload (products, packs) Legend EMVS EU Hub NMVS National Repository (SOOL) Digital certificate, issued by Arvato Digital certificate, issued by EMVO Requests and pack status changes for multi-market products NMVS web service calls Pharmacy internal communication 1) 1) 1) Counter 1 Counter 2 Counter 3 Server Counter 1 Counter 2 Counter 3 Pharmacy A: Direct connection of each counter to NMVS (not recommended) 1) Same certificate Pharmacy B: Connection to NMVS via local server (recommended) Nov. 22th, 2017 Kick-Off SOOL 10

System Architecture Overview Wholesalers: Integration scenarios Depending of the wholesalers setups and internal organizations two different kinds of integration scenarios can be considered: Direct connections of single branches (A) and concentration of communication via main branches (B). Mixed structures are feasible, as well. Wholesaler 1 National Repository (SOOL) (A) Branch 1 Branch 2 (A) Direct integration, the users (e.g. the branches of the wholesaler) communicate directly with the national hub. The types/versions of their software packages are known. (B) Wholesaler 2 Legend Local software installation Digital certificate, managed by Arvato Branch 1 Branch 2 (B) Some branches are hidden behind the main communication endpoint of the wholesaler. The software used can be proprietary and is not known to the National Repository. Nov. 22th, 2017 Kick-Off SOOL 11

Agenda Arvato Architecture NMVS Web Service Interface Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 12

Pack Status Transitions Verify Pack 1) Verify Pack 1) Exported Supplied (Dispensed) Dispense Export Check Out Checked Out Verify Pack 1) Verify Pack Undo Dispense Undo Export Undo Check Out Stolen Mark as Stolen 2) Active Undo Sample Sample Sample Undo Lock Undo Free Sample Destroy 2) Free Sample Legend Destroyed Lock Free Sample Active states Locked Inactive states Terminal inactive states 1) Verify Pack is available in all states 2) Undo destroy/stolen is technically available in Arvato s NMVS but will not be authorized for usage until the URS says so. Nov. 22th, 2017 Kick-Off SOOL 13

Status of a Pack (Serial Number) Extract from the EMVO URS: 1) Inactive 1) The expiry data can be extended or shortened by the MAH after the batch data have been submitted. Nov. 22th, 2017 Kick-Off SOOL 14

Transaction types Overview (1) Single Pack transactions Submit Single Pack Transaction Single pack transactions, e.g. Verify Single Pack, Dispense Single Pack, Destroy Single Pack Undo Single Pack Transaction Reverse single pack transactions, e.g. Undo Dispense (2) Homogenous Bulk transactions Submit Homogenous Bulk Transactions Bulk transactions are lists of transactions with the same product, batch id and transaction type. They are generated by wholesalers to handle large quantities of packs, e.g. Bulk Verify Packs, Bulk Export Packs. Request Homogenous Bulk Transactions Result Bulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted bulk transactions. (3) Mixed Bulk transactions Submit Mixed Bulk Transactions ( Offline Recap ) Offline bulk transactions contain transactions with heterogeneous products and transaction types. They are generated by pharmacies when the local transaction buffer is emptied after an offline period. Request Mixed Bulk Transactions Result ( Offline Recap ) Offline bulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted offline bulk transactions. Nov. 22th, 2017 Kick-Off SOOL 16

Transaction groups Overview G100 - Distributor Transactions G200 - MAH Transactions G300 Reports G400 - Administration G500 - EU Hub Transactions G600 - Stakeholder Onboarding Support G700 - Onboarding software suppliers Nov. 22th, 2017 Kick-Off SOOL 17

Transaction Types, Overview Transaction Type Pharmacy 1) Wholesaler 1) Verification X X Dispense X X Destroy X X Export X Sample, for authorities/sample archives X X Free sample, for healthcare professionals X Lock X Stolen X 1) X = Transaction authorized, Source: EMVO, URS EMVO_0015 European Medicines Verification System: Requirements Specification Part II, version 2016-10-20 Nov. 22th, 2017 Kick-Off SOOL 18

Web Service Group Single Pack Transactions (1) Web Service Id G110 G120 G122 G130 G140 G150 G160 G170 Web Service Name/Description Verify Single Pack Verify a single pack. This does not change the status of the pack. Dispense Single Pack Dispense a single pack using a scanner. All data matrix fields will be submitted (incl. product number, batch number, expiry date). Dispense Single Pack Manual Entry Dispense a single pack with manual data entry. Only the product number and the serial number will be submitted. Destroy Single Pack Report a single pack as destroyed. Export Single Pack Report a single pack as exported. Sample Single Pack Report that a single pack has been provided to authorities for sampling purposes. Free Sample Single Pack Report that a single pack has been given away as a free sample. Lock Single Pack Report that a single pack has been locked, e.g. to provide time for further investigations. Nov. 22th, 2017 Kick-Off SOOL 19

Web Service Group Single Pack Transactions (2) Web Service Id G180 G182 Web Service Name/Description Stolen Single Pack Report that a single pack has been stolen. Assumption: The data matrix content is still available (e.g. pack has been emptied or data from an earlier pack scan are still available). Stolen Single Pack Manual Entry Report that a single pack has been stolen, with manual data entry. Assumption: The product number and the serial number is still available (e.g. from an earlier scan). Nov. 22th, 2017 Kick-Off SOOL 20

Web Service Group Undo Single Pack Transaction Web Service Id G121 G131 G141 G151 G161 G171 G181 Web Service Name/Description Undo Dispense Single Pack Reverse the effect of a previous dispense transaction (G110 or G120). Undo Destroy Single Pack Reverse the effect of a previous destroy transaction. Undo Export Single Pack Reverse the effect of a previous export transaction. Undo Sample Single Pack Reverse the effect of a previous sample transaction. Undo Free Sample Single Pack Reverse the effect of a previous free sample transaction. Undo Lock Single Pack Unlock a previously locked pack. Undo Stolen Single Pack Reverse the effect of a previous stolen transaction (G180 or G182). Nov. 22th, 2017 Kick-Off SOOL 21

Bulk Transactions Function Principle Submit a list of homogeneous single pack requests as one bulk request (wholesalers only): Header: Product Number Batch Id Transaction Type Client Transaction Id List Element 1: Serial Number 1 List Element 2: Serial Number 2... List Element n: Serial Number n Request the result of the bulk request, two possible results: a) Ongoing processing b) Processing finished (only errors are returned): Message: Processing still ongoing, please try again later Header: Product Number Batch Id Transaction Type Client Transaction Id List Element n 1 : Serial Number s 1 Error Message 1... List Element n k : Serial Number s k Error Message k Nov. 22th, 2017 Kick-Off SOOL 22

Web Service Group Bulk Transactions (1) Web Service Id G115 G125 G135 G145 G155 G165 G175 G185 Web Service Name/Description Bulk Verify packs Submit a list of serial numbers (same product and batch) for verification. Bulk Dispense packs Submit a list of serial numbers (same product and batch) to report the corresponding packs as dispensed. Bulk Destroy packs Submit a list of serial numbers (same product) to report the corresponding packs as destroyed. Bulk Export packs Submit a list of serial numbers (same product) to report the corresponding packs as exported. Bulk Sample packs Submit a list of serial numbers (same product) to report that the corresponding packs have been provided to authorities for sampling purposes. Bulk Free sample packs Submit a list of serial numbers (same product) to report that the corresponding packs have been given away as free samples. Bulk Lock packs Submit a list of serial numbers (same product) to report the corresponding packs as locked. Bulk Stolen packs Submit a list of serial numbers (same product) to report the corresponding packs as stolen. Nov. 22th, 2017 Kick-Off SOOL 23

Web Service Group Bulk Transactions (2) Web Service Id G127 G137 G147 G157 G167 G177 G187 Web Service Name/Description Bulk Undo Dispense packs Submit a list of serial numbers (same product) for which the effects of a previous dispense transaction shall be undone. Bulk Undo Destroy Packs Bulk Undo Export Packs Bulk Undo Sample Packs Bulk Undo Free Sample Packs Bulk Undo Lock Packs Bulk Undo Stolen Packs Nov. 22th, 2017 Kick-Off SOOL 24

Web Service Group Request Bulk Transaction Results Web Service Id G116 G188 Web Service Name/Description Bulk Verify Packs Result Fetch the result of a previously submitted bulk verify transaction Request Bulk Pack Operation Result Fetch the result of a previously submitted bulk transaction other than bulk verify. Nov. 22th, 2017 Kick-Off SOOL 25

Mixed Bulk Transactions Function Principle Submit a list of mixed single pack requests as one bulk request (pharmacies only): Header: Client Transaction Id List Element 1: Product Number 1 Serial Number 1 Transaction Type 1 List Element 2: Product Number 2 Serial Number 2 Transaction Type 2... List Element n: Product Number n Serial Number n Transaction Type n Request the result of the bulk request, two possible results: a) Ongoing processing b) Processing finished: Message: Processing still ongoing, please try again later Header: Client Transaction Id List Element 1: Product Number 1 Serial Number 1 Transaction Type 1 Result 1 List Element 2: Product Number 2 Serial Number 2 Transaction Type 2 Result 2... List Element n: Product Number n Serial Number n Transaction Type n Result n Nov. 22th, 2017 Kick-Off SOOL 26

Web Service Group Mixed Bulk Transactions Web Service Id G195 Web Service Name/Description Mixed Bulk Transaction 1) A mixed bulk transaction contains multiple single transactions with heterogeneous products and transaction types. As an example, it is generated by a pharmacy when the local transaction buffer is emptied after an offline period. 1) Only such transaction types are allowed within mixed bulk transactions which are permitted as single transactions for a user. Nov. 22th, 2017 Kick-Off SOOL 27

Web Service Group Request Mixed Bulk Transaction Results Web Service Id G196 Web Service Name/Description Request Mixed Bulk Transaction Result Request the result of a previously submitted mixded bulk transaction. Nov. 22th, 2017 Kick-Off SOOL 28

Web Service Group Request Pending Bulk Transaction IDs Web Service Id G199 Web Service Name/Description Request Pending Bulk Transaction IDs Request a list of transaction ids of the bulk transactions which are still pending at the time of the request. If such ids have been lost for some reason, this web service recovers all bulk transaction ids whose results have not been fetched yet. Nov. 22th, 2017 Kick-Off SOOL 29

Web Service Group Authentication Web Service Id G445 Web Service Name/Description Change password G615 Download client certificate Nov. 22th, 2017 Kick-Off SOOL 31

Agenda Arvato Project Approach Architecture Use Cases Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 32

NMVS User Management: What are User Groups? User groups (also called clients ) are created by NMVOs to unite end users with the same properties, e.g. access rights User group A (client) Individual Pharmacies User group B (client) Chain XYZ Pharmacies User group C (client) Wholesalers Users Pharmacy P1 Pharmacy C1 Wholesaler W1 Pharmacy P2 Pharmacy C2 Wholesaler W2... Pharmacy P3 Pharmacy C3 Pharmacy P4 Pharmacy C4...... Nov. 22th, 2017 Kick-Off SOOL 33

NMVS User Management: What are Organisation Types? Each user group has one of several predefined Organisation Types. The selected Organisation Type defines the maximum set of access rights that each user of the user group can be granted. User group A (client) Individual Pharmacies Org. Type = Pharmacy User group B (client) Chain XYZ Pharmacies Org. Type = Pharmacy User group C (client) Wholesalers Org. Type = Wholesaler Pharmacy P1 Pharmacy C1 Wholesaler W1 Pharmacy P2 Pharmacy C2... Wholesaler W2 Pharmacy P3 Pharmacy C3 Pharmacy P4 Pharmacy C4...... Nov. 22th, 2017 Kick-Off SOOL 34

NMVS User Management: What are Roles? Based on the Organisation Type, the NMVO may define different Roles and assign them to individual users Business Process G110 Verify Single Pack Organisation Type Pharmacy Pharmacy Role IndP-A Pharmacy Role IndP-B Pharmacy Role ChP Yes Yes Yes Yes User group A (client) Individual Pharmacies Org. Type = Pharmacy User group B (client) Chain XYZ pharmacies Org. Type = Pharmacy G120 Dispense Single Pack G130 Destroy Single Pack Yes Yes Yes Yes Yes Yes No Yes Pharmacy P1 Role = IndP-B Pharmacy C1 Role = ChP G140 Export Single Pack G150 Sample Single Pack No No No No Yes Yes Yes Yes Pharmacy P2 Role = IndP-A Pharmacy C2 Role = ChP G160 Free Sample Single Pack No No No No Pharmacy P3 Role = IndP-A Pharmacy C3 Role = ChP G170 Lock Single Pack No No No No G151 Undo Free Sample Single Pack Yes Yes Yes No Pharmacy P4 Role = IndP-B Pharmacy C4 Role = ChP...... = Further restriction of the maximum rights set for organisation type Pharmacy Detailed description of Roles and Rights: Document PD-009_Roles and Rights Concept v1.0.pdf Nov. 22th, 2017 Kick-Off SOOL 35

NMVS User Management: How are usage rights per Organisation Type defined? An Excel document (see extract below) defines the available organisation types and their corresponding usage rights. This data is directly fed into the NMVS database. Nov. 22th, 2017 Kick-Off SOOL 36

Agenda Arvato Project Approach Architecture Use Cases Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 37

Onboarding Procedure for Software Suppliers (1) (1) Software Supplier registers with the NMVS Software Supplier portal and applies for access. (2) NMVO checks the request and approves access to the NMVS Software Supplier Portal. (3) Software Supplier... downloads documentation (handbooks, WSDLs, XML) checks for news & updates submits questions and service requests downloads certificates for the NMVS Integration Environment downloads test sets to...... test against the NMVS Integration Environment... qualify its software for the NMVS Production Environment Nov. 22th, 2017 Kick-Off SOOL 38

Onboarding Procedure for Software Suppliers (2) Which systems are important for Software Suppliers? NMVS Software Supplier Portal Registration page Login page https://sws-nmvs.eu/register Register as a Software Supplier https://sws-nmvs.eu Login and access documentation NMVS Certificate Management System Login page Generic NMVS Integration Environment End points https://portal-pki-int-bp.nmvs.eu/nmvs_portal_pki Login and download a certificate to connect with the NMVS Integration Environment (switch to English language on the upper right side of the page) https://ws-single-transactions-int-bp.nmvs.eu:8443/ws_single_transactions_v1/singlepackservicev10 Call web services via end points on the Generic NMVS Integration Environment, e.g. single pack transactions via the end point shown above Nov. 22th, 2017 Kick-Off SOOL 39

Onboarding Procedure for Software Suppliers (3) How does the registration process work in detail? After you have registered and been approved by the NMVO, you will receive three e-mails. 1. E-mail 1 informs you that you have now access to the Software Supplier Portal. Just use the credentials you have defined during the registration process (i.e. your e-mail address and the password you have chosen). 2. E-mail 2 provides additional user credentials for the NMVS Certificate Management System and the Generic NMVS Integration Environment. You will use these credentials to access the NMVS Certificate Management System and to authenticate yourself towards the Generic NMVS Integration Environment (together with the digital certificate downloaded in step 3). 3. E-mail 3 provides a TAN which is required to download your individual digital certificate from the NMVS Certificate Management System. Important: Do not forget to note the passphrase which will be displayed when downloading the certificate. You will need the passphrase to activate the certificate. Nov. 22th, 2017 Kick-Off SOOL 40

Software Supplier Portal Walkthrough https://sws-nmvs.eu Nov. 22th, 2017 Kick-Off SOOL 41

Agenda Arvato Project Approach Architecture Use Cases Roles and Rights Onboarding Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 42

High level Project Plan Letter of Intent Contract finished Remark: Modifications of timeline could occur during the project specification Setup Integration I Integration II Project start System is available Preparations Pilot partners connected Productive partners connected Pilot Phase Rollout Phase Hypercare Start MAHs Start pharmacies/ wholesalers Pilot phase finished Fully operational (SLA) Go Live Start of standard operations Timeline (Proposal): Project Phases: 2017-Nov 2018-Mar 2018-May 2018-June 2018-Nov 2019-Feb-09 Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Onboarding of last minute stakeholders, official production start Nov. 22th, 2017 Kick-Off SOOL 43

Time Planning, High Level Perspective There are roughly 15 months left until medicine verification becomes mandatory in Europe This is our plan to complete the project within the available time frame from Slovakia: Nov. 1st, 2017 Feb 9, 2019 Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Onboarding of last minute stakeholders, official production start Nov. 22th, 2017 Kick-Off SOOL 44

Planning, Detail View Phase 2: Ramp-up A (Mar 2018 Apr 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals During phase 2, the highlighted information flows will be observed: Phase 5 Production Feb 9, 2019 MAH Data upload (products, packs) EU Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Nov. 22th, 2017 Kick-Off SOOL 45

Planning, Detail View Phase 3: Ramp-up B (Apr 2018 May 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Feb 9, 2019 During Phase 3, additional data flows will be included: MAH Data upload (products, packs) European Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Requests and pack status changes for multi-market products Requests and pack status changes Wholesaler Pharmacy Officine, hôpital Wholesaler software Web app Pharmacy software Web app Verification, dispense early birds Nov. 22th, 2017 Kick-Off SOOL 46

Planning, Detail View Phase 4: Ramp-up C (Jun 2018 Oct 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Feb 9, 2019 During Phase 4, the functionality of the various pharmacy and wholesaler software systems will be included: MAH Data upload (products, packs) European Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Requests and pack status changes for multi-market products Requests and pack status changes Wholesaler Wholesaler Pharmacy Officine, hôpital Pharmacy Wholesaler software Web app Pharmacy software Web app Verification, dispense Nov. 22th, 2017 Kick-Off SOOL 47

Planning, Detail View Phase 5: Production (Nov 2018 Feb 2019) Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Phase 1 Initialization Preparation Feb 9, 2019 Results until Feb 9, 2019: The new developed pharmacy/wholesaler software systems have been installed at all pharmacies and wholesalers The verification of medicines has become a routine at the pharmacies and wholesalers. Almost all medicament packs on the Slovakian market are now serialized. Nov. 22th, 2017 Kick-Off SOOL 48

Arvato Systems https://it.arvato.com Heike Rikus Managerin Publishing Solutions Heike.Rikus@Bertelsmann.de Phone: +49 (0) 5241/80-43674 Nov. 22th, 2017 Kick-Off SOOL 49

Backup Nov. 22th, 2017 Kick-Off SOOL 50

Serialized Product Landscape Domestic Market Other EU Markets 2) Non-EU Markets Domestic Blacklist Serialized non-prescription medicament packs, e.g. Opremazol Non-serialized nonprescription blacklist medicament legacy packs Serialized nonmedicament packs (including serialized veterinarian medicaments) Non-serialized nonmedicament packs (including non-serialized veterinarian medicaments) Non-serialized non-prescription medicament packs from the domestic market Other EU Markets Blacklist Serialized non-prescription medicament packs from other EU markets, e.g. Opremazol Non-serialized nonprescription blacklist medicament legacy packs Non-serialized legacy medicament packs from other EU markets Section bound to disappear over time Non-medicaments Non-prescription medicaments Domestic serialized medicament packs NMVS requests will lead to standard transactions Serialized prescription medicament packs from the domestic market Serialized prescription medicament packs from other EU markets (no market authorization, special dispense permission required) Prescription medicament packs from non-eu markets (no market authorization, special dispense permission required) Prescription medicaments Domestic Whitelist 1) Non-serialized prescription medicaments, e.g. Radionuclides Medical gases Contrast media Non-serialized medicament legacy packs from the domestic market This section is bound to disappear over time 1) Whitelist products must never be serialized 2) This includes late EU markets like Italy or Greece Serialized medicament packs from other EU markets NMVS requests will lead to intermarket transactions Other EU Markets Whitelist 1) Non-serialized prescription medicaments from other EU markets, e.g. Radionuclides Medical gases Contrast media Nov. 22th, 2017 Kick-Off SOOL 51

Serialized Product Landscape Decision Table: When should the NMVS be requested? Nov. 22th, 2017 Kick-Off SOOL 52

How to decide whether to send an NMVS request from a local software Nov. 22th, 2017 Kick-Off SOOL 53