A Closer Look at the EU-FMD "Safety Features" Delegated Act

10 Things Pharma Manufacturers need to consider

3C PictureThe European Falsified Medicines Directive (EU-FMD) is an important piece of legislation that will impact every participant in the healthcare supply chain in 32 states in Europe – the 28 EU member  states  as  well  as  the  3  Non-EU  European  Economic  Area  (EEA)  members  Norway, Iceland  and  Liechtenstein  as  well  as  Switzerland  –  and  be  of  particular  importance  to pharmaceutical  manufacturers  who  face  a  significant  task  preparing  themselves  for compliance  within  a  three  year  timeframe from the  publication  in  the  Official  Journal  of  the European Union.

With the release of this final draft, the date of publication now looks imminent: If there are no major  objections  arising  from  the  final  consultation  round  (that  will  focus  on  the  impact  on international  trade)  we  could  see  the  publication  before  the  end of  this  year,  and even if  the publication  should  slip  into  Q1  2016,  compliance  with  the  EU-FMD  Safety  Features  measure will be required by Q1 2019 at the very latest.

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