European Falsified Medicines Directive

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European Falsified MedicinesDirective


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


EU Falsified Medicines Directive

Contains 4 Delegated Acts:

FMD2011/62/EU

Internet Sales

Good Distribution

Practice

API Traceablily

Safety Features


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


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)



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.


Authentication Data Flow

EU Hub managed by European Medicines Verification Organisation A non-profit organisation



Tamper Evidence Feature- Applied on each unit of sale

• Label• Glue-end• Over-wrap• Mechanical closure


US Drug Quality &Security Act


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


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


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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European Falsified Medicines Directive