EU FMD Safety Features Delegated Act 2015 – EUDA

November 10, 2015 1:19 pm | Posted by Admin

In an ongoing effort to combat falsified medicines, the Falsified Medicines Directive (FMD) 2011/62/EU introduces a number of measures to ensure product and patient safety. Draft delegated acts were published in August 2015 with the legislation set to come into play three (3) years from the official publication of the delegated act in the EU Journal. The Directive 2011/62/EU can be grouped into four main pillars:

  1. Safety Features,
  2. Good Distribution Practices,
  3. Active substance controls, and
  4. Internet sales awareness.

This Directive will impact the entire pharmaceutical supply chain from drug substance manufacturers to pharmacists dispensing medicines at point of sale.

We sat down with ESP’s Operations Manager, Paul Browne to discuss, in more detail, the 2015 EU FMD “Safety Features” Delegated Act (EUDA) and its impact for manufacturers and the supply chain…



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