De belangrijke rol van Regulatory Affairs bij de FMD

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Lennert Meijer
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1 De belangrijke rol van Regulatory Affairs bij de FMD NVFG RegNed Najaarsbijeenkomst 13 oktober 2016, AstraZeneca, Zoetermeer Armand Voorschuur, voorzitter Stichting NMVO Stichting NMVO Waar gaat het over? Falsified Medicines Directive (FMD) - Richtlijn 2011/62/EU van 8 juni 2011: om te verhinderen dat vervalste geneesmiddelen in de legale distributieketen belanden Delegated act (Commission Delegated Regulation (EU) 2016/161) - detailed rules for the safety features Middel tegen knoeien kiezen registratiehouders zelf Nieuwe 2D Data Matrix code op R x -verpakkingen Vereist een nieuw nationaal eco-systeem Keuze NL ketenpartners: nationaal Blueprint systeem Selectie van één van drie IT providers Bouwen, testen, vullen en opschaling naar volledige operationaliteit Nederlands Medicijnen Verificatie Systeem (NMVS) Deadline: 8 februari

2 Pharma obligation: apply safety features Manufacturers shall print on each individual pack of the products in scope: A Unique Identifier (UI), encoded in a 2D-datamatrix, composed of product code, randomised serial number, batch number and expiry date (and national reimbursement number if required) Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF Human-readable form of the UI information where not already present An anti-tampering device (ATD) must be applied to the pack Record-keeping: UI data to be kept for exp. + 1 year / 5 years minimum In practice: The manufacturers and parallel importers will have to ensure that: The unique identifier is placed on the pack for authentication; The serial number can be checked out at the dispensing point; The repository system is suitable to ensure authentication of medicinal products at the dispensing point; The response from the repository system is virtually instantaneous; The repository system guarantees the protection of commercial, confidential and personal data; The concerned competent authorities have full access to the repository system and can supervise its functioning. 2

3 Blokjes codes 2D Data Matrix* Bevat: - Product code - Batch number - Expiry date - Random serial number *) ECC200 Data Matrix code; EAN 128 syntax with Application Identifiers; GS1-compliant Blokjes codes 2D Data Matrix QR-code (Denso Wave, Japan) Ware grootte: ± 1 cm 2 3

4 Blokjes codes 2D Data Matrix QR-code Oók geschikt voor URL s! Niet op buitenverpakking! Eco-systeem 4

5 NMVS National Blueprint approach: Governance & Management European Hub EMVO Board EMVO IT provider to EMVO NMVO Board NMVO / EMVO Cooperation Agreement IT provider (short list) National Blueprint System Governance System management System operation Governance System management System operation Remit: EMVO Establish, manage and operate European Hub Ensure interoperability of connected systems Conclude agreements with NMVOs Set standards for the EMVS Manage national Blueprint systems at request of national stakeholders National Blueprint System Remit: Governance by national stakeholders Management by EMVO on behalf of the respective national stakeholders Operation by IT provider as preselected by EMVO 5

6 Europese Hub Scope of the NMVOs 6

7 EU-brede keten-samenwerking EMVO European Medicines Verification Organisation Membership open to other stakeholder associations Brede nationale samenwerking Bestuur Stichting NMVO: Vereniging Innovatieve Geneesmiddelen Armand Voorschuur, voorzitter BG-Pharma & VES Geo Aldershof, secretaris Bogin Martin Favié, penningmeester KNMP Jean Hermans, bestuurslid Informatie : 7

8 Total cost of an NMVO Hub cost (charged by EMVO) NMVO cost (governance and administration) System cost (charged by service provider) Estimate based on EMVO business plan and proposed allocation scheme Estimate by EMVO, to be reviewed country by country Estimate based on IT service providers standard offers, best and final offer to be negotiated country by country Tijdschema nationaal project 8

9 Europese stand van zaken Europese stand van zaken 9

10 Stichting Nederlandse Medicijnen Verificatie Organisatie Selectieproces IT Solution Provider Memorandum of Understanding - 26 april 2016 Stichting NMVO opgericht - 6 september 2016 Aantal MAH s in kaart aan het brengen Programma manager Letter of Intent Contract met solution provider Workstreams definiëren Toezicht: IGZ Iedere registratiehouder kan deelnemen Contactpersoon bij bedrijven: meld u aan bij de Stichting NMVO! 10

11 Afkortingen FMD DR DA EMVO EMVS NMVO NMVS NBPS - Falsified Medicines Directive - Delegated Regulation - Delegated Acts - European Medicines Verification Organisation - European Medicines Verification System - National Medicines Verification Organisation - National Medicines Verification System - National Blueprint System Countries in scope of the FMD 11

12 Scope extension by Member States possible Member States may extend (but not reduce) the scope of application of the unique identifier and/or of the anti-tampering device for the purpose of (Art. 54): Safety Feature Unique Identifier Tamperevidence Reimbursement or Pharmacovigilance Yes Patient Safety No Applicable to any medicinal product subject to prescription or reimbursement No Yes any medicinal product Must carry safety features under EUwide rules Prescription Medicines (Rx) Over the Counter Medicines (OTC) Extension of UI and/or TE application by Member States possible Whitelisted Products Blacklisted Products 12

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