european the eu rules on medicine...
TRANSCRIPT
EuropeanCommission
The EU rules on Medicine Serialisation
Agnès Mathieu-MendesDG SANTEEuropean Commission GIRP 59th annual meeting & conference“Falsified Medicines Directiveimplementation- Rallying regulatorycompliance”29 May 2018 - Dublin
Safer MedicinesSafety Features for Medicine Verification
Anti-tampering Device
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Unique Identifier
Unique identifier (UI) Anti-tampering device (ATD)
Safety features
Safety Features
Delegated Regulation(EU) No 2016/161
On prescription medicines only!
The Unique Identifier
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Ø A unique code on each pack
Ø carried by a 2D barcode (Data Matrix ECC200)
Ø Minimum printing quality (ISO 15415)
Ø Human-readable format
PC: 09876543210982SN: 12345AZRQF1234567890NN: (optional)Batch: A1C2E3G4I5Expiry: 032021
Illustrative example – not binding
Verification of the Safety Features
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End-to-end verification system + risk based verifications
Manufacturer Wholesaler Wholesaler PatientRetailer/
Pharmacist/ Hospital
Repositories with data
Verify + decommissionBarcode verify
Wholesaler
Systematic authentication at the end of the supply chain!
Risk-Based Verifications Wholesaler's obligations
Systematically verify the authenticity of:
Ø Returned medicinal products
Ø Medicinal products not received from:
§ the manufacturer;
§ the marketing authorisation holder;
§ a wholesaler designated by the marketing authorisation holder to distribute on his behalf.
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Wholesalers' Role
Can facilitate the decommissioning operation of hospitals/pharmacies;
Cannot decommission on behalf of hospitals/pharmacies;
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NationalSystem
Pharmacy Wholesaler
PharmaceuticalManufacturer
ParallelDistributor
NationalSystem
EuropeanHub
The Repositories System - Architecture
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Distributed System
modified from EMVO
Stakeholders' model!
Highlights of the last expert group meeting held on 10 April (1/2)
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•Working group (WG)1 on supervision: ongoing work on a supervision guideline and aide-memoire to be used by Member States when inspecting their national repositories. •WG2 on access to data: discussion on the prioritisation of reports (e.g. investigation and supervision reports, API and GUI)•WG3, Greece and Italy working on a draft paper on data transfer from their national systems to the EMVO/NMVOs during the transition period. •WG 4 on best practices discuss potential solutions to assist hospital pharmacies in decommissioning unique identifiers
•Call to include wholesale distribution authorisations in the EMA GMDP database
Highlights of the last expert group meeting held on 10 April (2/2)
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Follow-up of the progress with the databases
• 28 NMVOs founded but only 24 IT contracts signed (out of 29)
• Many repositories have started technical implementation but only eight have gone ‘live’
• No of users connected to the system dramatically low (< 10%)
• Hospitals preparadness still unsatisfactory
Discussion on the reporting of batch numbers of products bearing the safety features
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• Article 80(e) of DIR 2001/83/EC requires holders of distribution authorisations to provide, inter alia, for every transaction in medicinal products received, dispatch or brokered, the batch number of products bearing the safety features. • Solution proposed by ES: Directive does not prohibit wholesalers from providing multiple batch numbers, as long as the correct batch number is among them. • Acceptable interim solution to allow wholesalers to mention the most likely batches on the documentation accompanying the consignment they supply while waiting for scanning speed to evolve
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Implementation Challenges
Ø Timely set up of the IT infrastructure – the European and national databases;
Ø Creation of NMVOs and hiring of IT provider
Ø Setting up and pilot-testing the databases to minimise "teething" problems;
Ø Timely onboarding of verified users -users need time to learn to use the new system;
Ø The FMD = safer and better-quality EU medicines
Ø Safety features:
= no more false/expired/recalled medicines reach patients
= easier recalls and better (but not full) traceability
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Conclusions
OTHER INITIATIVES OF THE EUROPEAN COMMISSION
> The Regulation establishes:• support framework and procedures for cooperation on
health technology assessment at Union level• common rules for clinical assessment of health technologies
The Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.
HTA: Health and Technology Assessment
SHORTAGES OF MEDICINES
• Commission Questionnaire on MS implementation of Articles 23a and 81 of Directive 2001/83/EC
• Discussion paper on shortages
Ø Responsibilities of MAHs and wholesale distributors (includingtheir limits)
Ø Export restrictions
• HMA/EMA Task Force on availability of medicines presented theirwork on supply chain disruption and marketing of medicines(Brexit impact)
• Presentation of national measures by the Member States
