MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019

Transcription

1 ARVATO SYSTEMS MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019 Pascal Leppich, Arvato Systems Joseph Tshimbalanga, Systec & Services Abcoude, 22 June 2017

2 The WINDOW is CLOSING Now, the clock is ticking - Barack Obama days to go

3 You are obligated to serialize your Drugs as of 9 th February, 2019 In general, all drugs which are subject to prescription Unique Identifier (UI) alphanumerical code enabling the identification and authentication of individual packs Anti-tampering Device (ATD) device allowing the verification of whether a pack has been opened/tampered with Not specified by the Delegated Regulation

4 The Unique Identifier contains 5 Elements No Element Requirements 1 Product Code ISO-Compliant; < 50 characters, globally unique, issued by ISOcompliant coding agencies 2 Serial number unique per package; max 20 characters; randomized 1: Batch number 4 Expiry date 5 National reimbursement or identification number Optional element

5 Properties of the Unique Identifier The UI is carried by a 2D barcode (Data Matrix ECC200) Minimum printing quality Human-readable format

6 FMD Landscape in Europe

7 A complex web of stakeholders must learn to cooperate smoothly Exploitants CMOs Authorities Authorities approve new serialized medicaments EMVO, EU Hub MAHs use the EU Hub to upload their product/pack data Arvato uses the EU Hub to download product/pack data; Arvato implements changes of the URS Authorities Authorities define their needs concerning the data to provided NMVO Legend Stakeholder A Stakeholder B Stakeholder B depends on stakeholder A The CMOs have to prepare their production for serialization. Exploitants MAHs Exploitants Wholesalers receive medicaments from the MAHs MAHs use the NMVS (data analysis) Wholesalers use the NMVS Arvato Parallel distributors use the NMVS NMVO defines specific requirements (e.g. needs of the authorities) Software suppliers depend on Arvato to adapt/connect their software products Wholesalers Parallel distributors receive medicaments from the wholesalers Parallel Distributors Pharmacies use the NMVS Software Suppliers Pharmacies receive medicaments from the MAHs Pharmacies receive medicaments from the wholesalers Pharmacies Officines, Officines, hôpitaux hôpitaux Par. distributors use the EU Hub EMVO, EU Hub Pharmacies use the software products of the software suppliers

8 Serialization pieces Qualification & Validation Packaging (Artwork) Employee qualification & Training Additional Standard- Processes Serialization & Implementatio n Strategy Inclusive Management Adjustment up- /down stream BusinessProcesses (Level0-Level5) Interfaces to upstream IT-Systems & hubs Serialization pieces Selection Serialization- Technology Manufacturing Lines Collaboration of Interdisciplinary Project teams Integration of CMO & distribution partners 6/26/2017 Systec & Services GmbH Serialization Workshop Norway 8

9 YOUR journey to get compliant successfully! Preparation of the Project Involve your Partners Upgrade your Production Improve your Operations

10 Awareness, Support and Knowhow as Key Factors Forming of a dedicated project team and involve your decision makers is essential Assure management attention & support Get familiar with the FMD/DR and your requirements Train your Staff Allocate Project budget Preparation of the Project Integrate various business functions/departments (QM, IT, Marketing/Sales, HR, Purchasing, Legal, Regulatory affairs, Legal, Accounting, ) Get information about relevant coding/labeling standards for the local market Create awareness about your individual landscape of your organization

11 Serialization has a huge impact to your production Upgrade your Production Package design: Customize your package design (incl. artwork) Serialization might affect package size Master Data Management: Integrate your ERP System High degree of automatization Assign GTIN/NTIN to existing products Packaging line: Create technical preconditions Capacity might be reduced due to serialization Production Define Processes/Responsibilities: new/enhanced SOPs considering the new responsibilities, security aspects, etc. IT Solution: Select & implement a suitable Serialization Solution which meets your biz-case Cenral vs. decentral SN production Interfacing/Connection: Establish access to EU Hub Establish a process to upload master & pack data to the EU Hub

12 Improvement and Training is a Key Success Factor Ongoing establishment and improvement of processes during the upcoming month until 2019 Actual upload master and pack data to the EU Hub Assign responsible persons for serialization processes Train your remaining Staff considering the new Processes and Requirements Option: Prepare usage of NVMS Check product/package data in the NMVS (Quality checks) Generate reports

13 3 Must-Haves Proper comprehension Proper dedication Proper methodology 3 Must-Haves for a successful project

14 Comprehension A clear and complete understanding of regulations each role and responsibility serialization offering solutions timelines and dependencies

15 Dedication Knowing the processes Facing all challenges Keeping open communication Meeting the deadline Achieving success for the company

16 Methodology Design it and stick to it! A well designed methodology will help you build a track & trace system in line with your specific needs and also in line with global requirements.

17 Be prepared, You need to integrate various Business Partners Register with the EMVO

18 Onboarding Process You need to contract with EMVO to Upload Data Contacts: EMVO asbl Rue de la Loi 28, box 21 B-1040 Bruxelles Belgium Tel: Mail: helpdesk@emvo-medicines.eu

19 Be prepared, You need to integrate various Business Partners Register with the EMVO Register with your NMVO

20 Your NMVO in Netherlands is ready to start Take your opportunity and participate the NVS Pilot

21 Be prepared, You need to integrate various Business Partners Register with the EMVO Register with the NMVO Establish an intense communication stream with the NMVO to gather/share learnings from other market participants Onboard your CMOs (Contract Manuf. Orgs.): Define new processes, implement interfaces, modify contracts,... Align new processes with your wholesalers

22 Timeline example from Production until Despensing Assumption: The new product is equivalent to an already existing product, so no additional marketing/sales process is required. Design new package Print package mockup 1) Regulatory approval process 2) Send master data to EU Hub Send pack data to EU Hub ca. 140 days in German pilot project Print order for packages 1) Needs to be done on original production equipment 2) Takes up to three months Assign/prepare prod. capacities incl. serialization (2D Matrix code) 3) Start production Delivery to wholesaler Sell off stocks of previous, equivalent product 4) 4) Can be bypassed in the pilot phase Legend MAH process Announce product to wholesalers and pharmacies Wholesaler enters new product master data to internal ERP system Wholesaler orders product from MAH Delivery reception from MAH Delivery of new product to pharmacy Sell off stocks of previous, equivalent product 3) Wholesaler process Pharmacy process A B B depends on A 3) Capacity of production lines with serialization might be reduced, e.g. <5.000 / min instead of / min Pharmacy enters new product master data to internal ERP system Pharmacy orders product from wholesaler Delivery reception from wholesaler Dispense product

23 Leasons learned to enable Your Project smoothly 1 Start your project now, the time is running 2 Practice your processes 3 Early integration of your Partner network 4 Create and Search for long-term Partnerships high expertise is required

24 One more thing

25 Q&A Room for your questions!

26 6/26/2017 Name Arvato Systems Client Thank you for your attention!

27 YOUR CONTACTS Arvato Systems Systec & Services Pascal Leppich Manager Sales & Business Development Fuggerstraße Bielefeld Germany Phone: Mobile: Joseph Tshimbalanga International Sales Manager Emmy-Noether-Straße Karlsruhe Germany Phone: Mobile: (Germany) Mobile: (Belgium)