Belgian Medicines Verification Organisation End User Implementation
End User implementation Agenda Project planning and status End user FMD activity Controlled on boarding for early bird end users End user implementation check list Back up slides 14/02/2018 FMD - End User implementation 2
Planning, Overview May 1, 2017 December 2017 February 2018 May 2018 August 2018 Feb 9, 2019 Phase 1 Preparation & Setup of initial NMVS Version Phase 2 Onboarding of first MAHs/Par. Distributors Phase 3 Onboarding of first Wholesalers & Pharmacies/Hospitals Phase 4 Onboarding of remaining Wholesalers & Pharmacies/Hospitals Phase 5 Production Choose first MAHs and Parallel Distributors Choose first Wholesalers & Pharmacies/Hospitals Prepare onboarding of remaining Wholesalers & Pharmacies/Hospitals Optimize the ecosystem, prepare production phase 21 months from project start to the official launch date Today : less than 12 months remaining (including 6 months validation period) 3
End User activity - Pharmacy Verify Unique Identifier (GTIN+Ser.Code) when dispensing Can do verifications before, but always when delivery Also verification and decommissioning when Pack cannot be returned to wholesaler or manufacturer Pack is provided as sample to authorities Pack will be used as authorized investigational product or auxiliary medicinal product No verification when pack is provided as to him as free sample (but has to verify ATD) When supplying part of pack: decommission when opening the pack Always under the responsibility of the pharmacist When a technical problem reading the 2D matrix Use the GUI for verification and/or decommissioning Store the codes and submit at a later moment using the webservices Exceptions for Hospital pharmacies: Can decommission at any moment as long as the pack does not leave the hospital 14/02/2018 FMD - End User implementation 4
End User activity - Wholesaler Risk base verification Specific cases when the pack needs always to be verified Pack returned to him by pharmacy or hospital (or other client) Pack received from another wholesaler (who is not the WHS acting on behalf of the manufacturer) Also verification and decommissioning when Pack is exported outside EU Pack is returned to him by a client (pharmacy, ) and the pack cannot be returned into saleable stock Pack is intended for destruction Pack is provided to authorities as sample Pack is sold to persons/institutions outside the traditional supply chain 14/02/2018 FMD - End User implementation 5
End User on boarding May 1, 2017 December 2017 February May 2018 2018 End User controlled on boarding August 2018 Late connections Feb 9, 2019 Phase 1 Preparation & Setup of initial NMVS Version Phase 2 Onboarding of first MAHs/Par. Distributors Phase 3 Onboarding of first Wholesalers & Pharmacies/Hospitals Phase 4 Onboarding of remaining Wholesalers & Pharmacies/Hospitals Phase 5 Production Choose first MAHs and Parallel Distributors Choose first Wholesalers & Pharmacies/Hospitals Prepare onboarding of remaining Wholesalers & Pharmacies/Hospitals Roll out all End Users Optimize the ecosystem, prepare production phase 21 months from project start to the official launch date Today : less than 12 months remaining (including 6 months validation period) 6
End User Controlled on boarding Objective: Software teams have tested the development in ITA and IQE on the Arvato development portal Controlled on boarding allows the development teams to validate the solution in real life Production environment BeMVO/Arvato support: Close monitoring of the first users being connected List of product / packs that can be used for validation of implemented solution Support on implementation of admin services, handling of user credentials, Support on validation of transaction services, monitoring end user activity and feedback on submitted web services, Priority handling of issues Support on creation of end user information and training material Support on end user registrations Where needed, modify procedures based on feedback from participating end users 14/02/2018 FMD - End User implementation 7
End User Controlled on boarding (2) Early bird implementation process: Select early-bird user(s) Provide user information to BeMVO (input format provided by BeMVO) Agree on validation plan/timing with BeMVO and user(s) BeMVO provides list of packs considered for the pilot phase Implement FMD module for the early-bird user(s) Provide training, information, documentation to the early-bird users BeMVO create user(s) in the Verification system (BMVS) User(s) to go through the initial on boarding steps (password change, T&C and DPP acceptance) Confirm to BeMVO when first validations/tests will start BeMVO to monitor the early-bird user s activity during the Controlled on boarding period (February-May 2018) BeMVO feed back to SW vendor & user on a regular base Technical support: support@sws-nmvs.eu 14/02/2018 FMD - End User implementation 8
End User transactions, pack status changes Verify Pack 1) Exported Supplied (Dispensed) Dispense Export Check Out Checked Out 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.
End User implementation Check list User s action selection Scanner configuration Scanning input interpretation GTIN-CNK Conversion Scanned data management Pre-filtering for Webservices Create Data for Webservices User s multiple workstations setup Transmission approach Establish connection Return code handling Admin webservices GUI interface End User instructions 14/02/2018 FMD - End User implementation 10
Check list (1) User s action selection Type of transaction to initiate Single pack or Bulk transaction Homogeneous bulk for WHS Heterogeneous bulk for Pharmacies Manual input of pack data using the GUI Verification or Dispense Check data entry (eg GTIN=14) Scanner configuration Scanner settings for 2D matrix Configuration to users keyboard settings Still linear barcodes on packs (up to 5 years after 2/2019) Scanning input interpretation Identification of scanned 2D format/standard Identification of product code (GTIN/NTIN or PPN) De-compose scanned data elements according the GS1 standards Manage scanning issues (not readable, incorrect format, ) 14/02/2018 FMD - End User implementation 11
Check list (2) GTIN-CNK Conversion Update conversion table Handle update issues / errors Conversion table daily refreshed (entire table) Manage conversion issues GTIN not found Use of Webservice response Access to the conversion table is provided to registered users Scanned data management Store the scanned and de-composed information from the 2D matrix 14/02/2018 FMD - End User implementation 12
Check list (3) Pre-filtering for Webservices Only start webservice if pack is from a EU country, and the 2D code contains a UI (serialized), and pack is a human medicine To avoid false alert on code not found Create Data for Webservices Retrieve additional information for Webservice User credentials Transaction ID Software information Construct XML according selected transaction type 14/02/2018 FMD - End User implementation 13
Check list (4) Different connection scenario s depending on the user s organisation and set up 14/02/2018 FMD - End User implementation 14
Check list (5) Webservices transmission approach 1. Single pack synchronous transmission Execute webservice at each scan Combined with synchronous Undo 2. Single pack synchronous transmission (buffered) Buffer scans and execute webservices in background while User continuous scanning Display webservice responses at end of user s input if negative response Buffer scans and execute webservices when user is ending the input Display potential negative response at end of user s input 3. Asynchronous Bulk transmission Buffer scans in file and transmit heterogeneous Bulk transmission when user is closing the input Timer for Bulk response webservice 14/02/2018 FMD - End User implementation 15
Check list (6) Establish connection 1. User creation Prior to any set up: user needs to be created in BMVS (organisation, address, email, responsible person, SW information, ) 2. First connection of the End User When user connect first time: accept Terms&Conditions and Data Privacy Policy (also when new TC&DPP are introduced) Will also be accessible through the GUI 3. Connection using Login/Password/Certificate Establish connection using Login/Password and Certificate 4. Supporting webservices Change current password / Reset password Download certificate Automate the update of passwords and certificates in the users system based on the expiry dates (validity period) 14/02/2018 FMD - End User implementation 16
Check list (7) Return code handling - Different types of messages User credentials Invalid password, user name, certificate POS action: re-enter password, start webservice for new certificate, Invalid product, pack, code Manual entry check and re-enter Scan entry check scanned vs printed code If invalid: potential falsification keep pack aside for investigation Batch recalled, product withdrawal, expiry date, Current procedure Pack already dispensed, exported, destroyed, Potential falsification keep pack aside for investigations User locked, not registered, Inform Support desk Issue user system Operation not possible for user, xml file format invalid, SW vendor to fix NMVS System issue System does not respond, NMVS team to handle 14/02/2018 FMD - End User implementation 17
Check list (8) Admin webservices Functionality to download the Product Master (available in November release) Contains: GTIN CNK MAH code (blanc for the moment, will be SPOR ID when Hub connected to SPOR) List of wholesalers having a contractual relationship with the concerned MAH GUI interface Implementation of the GUI interface Similar transactions functionality as the webservices (except no bulk transmission) Allowing also: Admin services, T&C approval, Master data download End User instructions Documentation for the end users on new functionality in his pharmacy software What to do in case of 14/02/2018 FMD - End User implementation 18
Check list FMD related changes INAMI/RIZIV communication Legal framework concerning communication of UBC will be published end Q1/2018 UBC replaced by FMD unique identifier FMD-UI = GTIN+Serial Number UBC continues in parallel 3 fields UBC // CNK // FMD-UI Pharmacist to communicate UBC or FMD-UI 14/02/2018 FMD - End User implementation 19
Back up slides 14/02/2018 FMD - End User implementation 20
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 21
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 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 14/02/2018 FMD - End User implementation 22
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. 14/02/2018 FMD - End User implementation 23
Software Supplier Portal https://sws-nmvs.eu 14/02/2018 FMD - End User implementation 24