Pharmaceuticals

Falsified Medicines Directive - Compliance date confirmed

Delegated Acts on safety features in the EU Falsified Medicines Directive (FMD) have been published and a compliance date set.

 
Draft European Falsified Medicine Regulation Issued

Draft directive issued for a unique identifier and an anti-tampering safety feature to prevent falsified medicine in the supply chain in Europe

 
GS1 FMD Training and Advice

Advice and training from GS1 experts on implementing GS1 identification, barcoding and labelling standards such as GTINs, AIs and Data Matric Symbols for global serialisation requirements such as the EU falsified Medicines Directive (FMD).

 
Serialization Position Paper from EFPIA IFPMA and PhRMA

Serialisation and Product Verification - A Joint Position Paper from EFPIA IFPMA PhRMA to Help to Secure the Legal Supply Chain for Greater Patient Safety (Nov 2013)

 
Pharma Serialisation and the EU Falsified Medicines Directive

In a recently published shared vision for product identification, the European Federation of Pharmaceutical Industries and Associations (EFPIA) supports the use of GS1 standards for the identification of products.

 
Vaccines Track and Trace Pilot Supports Case for National Roll Out

UDG Healthcare ‘Track and Trace’ Immunisation Pilot Report Supports Case for National Roll Out of Vaccine Tracking (Feb 2014)

 
Obama signs Drug Quality and Security Act into law

Obama signs H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system for medicines.

 
ESP - GS1 Pharma Serialisation Industry Readiness Survey Report

A report on the May 2016 ESP - GS1 Ireland survey on industry readiness for pharmaceutical serialisation.

 
HUG Information Day 2017 on FMD and UDI

GS1 Healthcare User Group Information Day on Pharma Serialisation (Falsified Medicines Directive) and Unique Device Identification (UDI) for Medical Devices