by Nicolas Bohnet | Apr 26, 2016 | Blog
On February 9, 2016, the countdown to implementing the safety measures mandated by the Falsified Medicines Directive (FMD) Delegated Act started. This Act, which will come into force in early 2019, imposes item-level serialization and tamper evidence on pharmaceutical...
by Nicolas Bohnet | Mar 16, 2016 | Blog
The publication of the Delegated Regulation (EU) 2016/161I supplementing the Falsified Medicines Directive (FMD) 2001/83/EC and its amendment 2011/62/EU was finally published in the Official Journal of the European Union on February 9, 2016. This date marks the...
by Nicolas Bohnet | Jan 22, 2016 | Blog
Our previous blog article (Cost-Benefit Analysis of a ‘European Hub’ for Medicine Authentication) analyzed the cost-benefit of creating a European hub – the European Medicines Verification Organization or EMVO – to link national verification systems throughout Europe...
by Nicolas Bohnet | Nov 18, 2015 | Blog
As described in our previous blog (New Developments in the Fight Against Falsified Medicines), the European Medicines Verification Organisation or EMVO was founded in February 2015 as a means to help EU Member States implement the requirements set out by the Falsified...
by Nicolas Bohnet | Oct 7, 2015 | Blog
In addition to the recent publication of a draft delegated act laying down the technical specifications of the safety features, two other major developments have taken place since the EU Falsified Medicines Directive (2011/62/EU) came into effect in January 2013. The...
by Nicolas Bohnet | Sep 14, 2015 | Blog
The Falsified Medicines Directive (2011/62/EU) adopted in June 2011 and put into force in January 2013, calls on the European Commission to prepare and adopt delegated acts that will lay down the technical specifications of the safety featuresI, determine the methods...
