IDENTIFICATION & AUTHENTICATION OF MEDICINES IN EUROPE: OPPORTUNITIES AND CHALLENGES TO COMPLY WITH EU LEGISLATION
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1 IDENTIFICATION & AUTHENTICATION OF MEDICINES IN EUROPE: OPPORTUNITIES AND CHALLENGES TO COMPLY WITH EU LEGISLATION CHINA/EU PHARMACEUTICAL FORUM TH APRIL 2018 BASEL, SWITZERLAND Andreas Walter (General Manager)
2 AGENDA FMD/DR EMVO/EMVS Status Implementation Achievements & Challenges 2
3 3
4 FMD LEGISLATION AND DELEGATED ACT July 2011 Publication of FMD 9 Feb 2016 Publication of Delegated Regulation 36 Mon. 9 Feb 2019 Mandatory verification of all packs in scope 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) 4
5 THE DELEGATED REGULATION MANDATES RULES FOR MEDICINES VERIFICATION Serialization by manufacturer Risk based verification by Wholesalers Verification and check-out at point of dispense Safety features: Code ( unique identifier ) + Tamper evidence Product #: S/N: 12345AZRQF Batch: A1C2E3G4I5 Expiry: System set up and governed by manufacturers and marketing auth. holders in consultation with other stakeholders. Oversight by competent authorities 5
6 AGENDA FMD/DR EMVO/EMVS Status Implementation Achievements & Challenges 6
7 SYSTEM LANDSCAPE 7
8 SYSTEM LANDSCAPE OBP OBP NMVO OBP: On-boarding Partner NMVS: National Medicines Verification System NMVO: National Medicines Verification Organisation 8
9 EMVO MEMBERS 9
10 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) Tel. Helpdesk General Management Andreas Walter Markus Gerigk (external consultant) Commercial & Partner Management Tobias Beer Opera4ons Koen Van Gompel Office Management Marisa Jimenez Sanchez Quality Assurance Stephan Theunissen Fanny Trenteseaux Emmanouela Nikolakopoulou Jannik Jäger (intern) André Geraldes João Pacheco AnneSe Aragones Intern Intern Intern Willem Theunissen (external consultant) Paul Mills (external consultant) Intern 10
11 FIRSYT LINE SUPPORT: EMVO SERVICE CENTRE (Tallinn) Tel. Helpdesk
12 Agenda FMD/DR EMVO/EMVS Status Implementa\on Achievements & Challenges 12
13 STAKEHOLDER GOVERNANCE: NMVO NMVO Incorporated (all stakeholders) NMVO Incorporated (stakeholder missing) No NMVO Non EU Countries
14 BLUEPRINT TENDENCY Blueprint candidate Small Country Blueprint Blueprint open Standalone system 16 3 Non EU Countries
15 DR-COMPLIANCE 02/2019: VERY LATE COUNTRIES Governance Technical Align MoU Stat NMVO PM ProvC ProvS Contr B R 13 Hungary 18 Liechtenstein 21 Malta 24 Poland 25 Portugal 31 Switzerland 32 U. Kingdom Align = Stakeholder Alignment MoU = MoU signed Stat = NMVO Statutes signed NMVO = NMVO implemented PM = Project Manager assigned ProvC = Provider Contacts established ProvS = Provider selected Contr = Provider Contract signed = Incomplete Stakeholder Participation Greece and Italy not heading for
16 MAH ON-BOARDING Above Target Below Target Actual Target 100%
17 SIGNED PARTICIPATION AGREEMENT BY OBPS PER COUNTRY Austria Belgium Bulgaria Croatia Cyprus CZ Denmark Estonia 15 Finland France Germany Greece Hungary Iceland Ireland Italy 23 Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland UK Additional PA signed by OBPs in non-european countries: OBPs 2 OBPs 1 OBP 17
18 STATUS ON-BOARDING Target figure: Number Earlier May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Janv-18 Feb-18 Mar-18 Signed Participation Agreements OBPs connected to Hub V2 (PRD) Legitimacy check passed 18
19 NMVS READINESS Early Adopter Main Stream Late Follower 16 3 Not started
20 END USER READINESS Above Target 2 6 Below Target
21 AGENDA FMD/DR EMVO/EMVS Status Implementation Achievements & Challenges 21
22 CHALLENGES & ACHIEVEMENTS ON EUROPEAN LEVEL Challenges Achievements Ø Set-up EMVO & EU Hub Ø NMVO incorporated & NMVS selected (provider contract signed) Ø Connect approx. 2,291 On-boarding Partners (OBPs) to the EU Hub Ø Connect 27 (+5) NMVS to the to the EU Hub: Ø Cooperation Agreement (CA) signed Ø NMVS assessments & technical on-boarding Ø On-boarding/certification of connection providers ü EMVO incorporated & EU Hub upgraded 2.0 (but limited resources) ü 29 NMVOs (>75%) founded, ü 30 countries choose Blueprint ü 656 OBPs in Portal, 545 PA signed, 13 in PRD. Scheduled: end of Q ü 21 CA signed ü Only Germany connected to EU Hub (PRD) 22
23 CHALLENGES & ACHIEVEMENTS ON NATIONAL LEVEL: HOSPITALS Defining a communication strategy (including NCAs!) to increase awareness in member states at all levels Limited knowledge of FMD in health (and social) care Limited involvement of hospital expertise in NMVOs Defining a strategy to get the involvement of hospital expertise in NMVOs NCAs/NMVOs TO ACT Updating HOPE/EAHP mapping exercise with current situation including: Governance indicators Awareness indicators Technical indicators Limited information on onboarding Limited crossinformation between MS on issues and solutions Collecting of case studies/ national pilots; Gathering a consensus on issues and solutions 23
24 CHALLENGES & ACHIEVEMENTS ON NATIONAL LEVEL: INVOLVEMENT NCAs Challenges Achievements Ø NCAs in several countries not involved reg. operations (awareness raising of end users and national manufacturers/ MAHs) Ø Nearly no support of NCAs reg. hospital integration in almost all countries (ownership, budgeting, awareness, etc.) Ø Access to data by NCAs: Extended reporting requested ü Slow progress and low feedback(despite EMVO circular) ü No progress or feedback (despite EMVO circular) ü Constructive dialogue NCAs (WG II)/EMVO in order to harmonise access to data/reporting throughout Europe. Common position possible. NCAs/EMVO/NMVOs TO ACT 24
25 CONCLUSION: EUROPE CAN BE READY, IF.. There is strong involvement, commitment and cooperation of all supply chain stakeholders on European and national level: It is a European, not only a national project! NCAs play their role: Raising awareness, supporting the implementation process, hospitals, coding requirements, voluntary use of the safety features, regulatory pathway to implement the Safety Features, art work requirements, etc. Without support, the timely implementation could be at risk! COM supports the implementation process and clarifies the legislation (awareness, Q&A, etc.) 25
26 Tel. Helpdesk:
27 BACKUP o EMVO Website Process Description for Pharmaceutical Companies & OBP Portal Knowledge Database & Documents Overview o Documentation On-boarding Checklist Presentation, Guideline, Master Data Guide 27
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TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 15699 January 2009 ICS 35.240.80 English Version Health informatics - Clinical knowledge resources - Metadata Informatique
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