spacer
home > pmps > spring 2017 > is europe ready?
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Is Europe Ready?

February saw an important milestone for all pharmaceutical manufacturers supplying the European market and their supply chain partners – the 9th marked the beginning of the two-year countdown until the EU’s Falsified Medicines Directive (EU-FMD) compliance mandate comes into force across Europe. From that date, pharma companies will no longer be able to legally put products on the European market unless they comply with the three critical ‘safety features’ requirements. Every pack of medicines must be:
  • Tamper-evidenced
  • Carrying a 2D data matrix encoding a unique identifier (UI)
  • The UI must have been uploaded into a Europe-wide system of repositories for systematic check-out at pharmacies
Achieving readiness to fulfil these conditions is a huge undertaking and the question being asked is: ‘How realistic is the prospect that Europe will be ready in February 2019?’ In order to answer this, let us consider the different areas of work in turn.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Christoph Krähenbühl, Senior Director at 3C Excellis Europe, is widely recognised as a thought leader in pharma serialisation. He has been involved in serialisation schemes since 2006 as Serialisation Project Manager and Product Security Manager at AstraZeneca. Christoph has also been supporting the European stakeholder response to the EU-FMD as an expert on the European Federation of Pharmaceutical Industries and Associations team and as a member of the EMVO management team.
spacer
Christoph Krähenbühl
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

When space is tight

Existing packaging lines can be retrofitted for serialization tasks, achieving a maximum of space savings and process reliability: if required, the system comes with an integrated checkweigher and tamper-evident labeler.  
More info >>

White Papers

PROTEIN:PROTEIN INTERACTION ANALYSIS

IBA GmbH

Groth et al., 2007 and Jasencakova et al., 2010 Protein:protein-interactions (PPI) govern almost all important processes in living organisms. Thus, their rapid and accurate determination and investigation is a major challenge in life sciences. The extremely efficient and fast One-STrEP (Twin-Strep) system is suitable for the isolation of functional protein complexes and subsequent mass spectrometry analysis leads to the identification of protein complex components (Junttila et al., 2005) as it is shown in the following studies.
More info >>

 
Industry Events

PREP 2018: 31st International Symposium and Exhibit on Preparative and Process Chromatography

8-11 July 2018, Hyatt Regency in the Baltimore Inner Harbor, MD, USA

The PREP series of symposia is the most recognized international conference devoted to advances in separation technologies in the field of preparative and process chromatography. Join us for a dynamic and innovative program where experts from around the world will address the latest developments and hottest topics in preparative and process chromatography.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement