european falsified medicines directive
TRANSCRIPT
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European Falsified MedicinesDirective
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EU Falsified Medicines Directive
Issued by DG SANCO- EU Directorate General of Health & Food
Safety
EU Directive 2011/62/EU- “To reduce the occasions on which falsified
medicines enter the legitimate supply chain”
Contains 4 Delegated Acts
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EU Falsified Medicines Directive
Contains 4 Delegated Acts:
FMD2011/62/EU
Internet Sales
Good Distribution
Practice
API Traceablily
Safety Features
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Delegated Act - Safety Features
Timeline:- Adopted 2nd October 2015- Published 9th Feb 2016- Enforced 36 months from approval date
• Exception of Belgium, Italy, Greece - Applies to all prescription products
manufactured after this date
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Delegated Act - Safety FeaturesSafety Features will enable wholesale distributors and pharmacists to:1. Verify the authenticity of the medicinal product
2. Identify individual packs
3. Verify by means of a device, whether the outer packaging has been tampered with
Compulsory for prescription medicines (with some exceptions)
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Delegated Act - Safety Features
Unique Product Identifier- 2D Matrix (data carrier)
• GTIN– 14 digit global product number
• Serial Number• Lot Number• Expiry Date• National Reimbursement No
- Human readable Information.
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Authentication Data Flow
EU Hub managed by European Medicines Verification Organisation A non-profit organisation
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Delegated Act - Safety Features
Tamper Evidence Feature- Applied on each unit of sale
• Label• Glue-end• Over-wrap• Mechanical closure
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US Drug Quality &Security Act
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US Drug Quality Security Act
Became law in November 2013Applies to all prescription drugs with few exceptions Enforced from 27th November 2017Aggregation is not specified but is expected from major US distributors
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DQSA Title II
Title II:- Drug Supply Chain Security Act- “the system will facilitate the exchange
of information at the individual package level about where a drug has been in the supply chain.”
Drug Quality Security Act
(Enacted Nov 2103)
Title I:Compounding
Quality Act
Title II:Drug Supply Chain
Security Act
Product Tracing
Wholesale, Distributor & 3PL Licensing & Stnds
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US Drug Quality Security Act
Major provisions1. Product tracing
• By lot level – 2015• By package level 2023
2. Product Verification• Quarantine & investigation• Notification & record keeping
3. Product Identification• Applied to product Nov 2017
Product Identifier consists of:- National Drug Code- Serial number- Lot number- Expiration date
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Introduction to Serialisation
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Sharp’s SerialisationExperience
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Thank You