Directive 2011-62-EU

Directive 2011-62-EU

Directive 2001/83/EC codifies principles for the preparation, approval, marketing and supervision of medicinal products


Directive 2011/62/EU amending  Directive 2001/83/EC introduces obligatory ‘safety features‘
- a unique identifier and an
- anti-tampering device
as part of the outer packaging of prescription medicinal products.

Directive 2011/62/EU

  • 2D Matrix printers with serialization software on all lines
  • Tamper evidence (glueing technology) on 2 lines



Directive 2011/62/EU 2012-2017
Start of hardware installation 2012
Outsourcing Data Management 2014
Serialisation  
Hard and Software 2015
Process Validation 2015-2016
Roll-out period 2016-2017
Tamper Evidence  
Glueing technology on 2 lines 2015
Process Validation 2015-2016
Roll-out period 2016-2017
Aggregation „line to ramp“ 2017