Subscribe
  
IPQ Inside the global regulatory dialogue

EC Publishes Concept Paper on Safety Features to Support Falsified Medicines Legislation

Dec 3rd, 2011

Please Log in to print the full article

In mid-October, the European Commission (EC) published a concept paper for public consultation on proposed requirements for “safety features” for medicinal products as part of its implementation of the EU falsified medicines legislation.  Comments are due by April 27, 2012.

The concept paper results from a requirement in the legislation for the commission to propose details on safety features – one of the four “pillars” contained in the legislation (IPQ “In the News” May 31, 2011).  The other three pillars are: ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales.

Adopted by the EC in May, the legislation is aimed to significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in the four “pillar” areas.

A complimentary thrust of the European effort to combat the counterfeiting of medicinal products is the “Medicrimes Convention, established by the Council of Europe in late October, which provides for a ramping up of the criminal and monetary penalties among the signatories (IPQ “In the News” December 1, 2011).

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $95 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See recent related IPQ stories:

Anticounterfeiting Initiatives on Criminal Penalties and Serialization Advance in the US and Europe

Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators

GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom

Complying With Serialization Mandates Requires Long Lead Times, Experts Warn

Pages: 1 2

    ©2021 IPQ Publications