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

Three-tiered, mobile-app driven program tracks individuals’ physical and psychological symptoms from COVID-19

RALEIGH, N.C., March 20, 2020 (GLOBE NEWSWIRE) -- PRA Health Sciences announced today the commercial availability of the COVID-19 Monitoring Program, a mobile app-driven, tiered initiative that allows employers, payers, providers and health systems to track the health and wellbeing of individuals who may be asymptomatic, exposed or diagnosed with COVID-19 during the pandemic.
More info >>

White Papers

The Rare Disease Patients Experience

When planning a clinical trial for a rare disease, it is important to have a holistic understanding of your patient population. You want to be aware of where your patients are coming from, and what it is like to walk in their shoes. These patients need your trial just as much as you need them; even from the earliest stages, conceptualize your rare disease trial as an altruistic relationship between the patient population and your study.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement