by Nicolas Bohnet | Apr 21, 2017 | Blog
According to the World Health Organization, over 920 Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products have so far been reported.I These products are manufactured in all regions of the world. In response, regulation in many...
by Nicolas Bohnet | Feb 13, 2017 | Blog
In April 2016, we reported on Title II of the Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act or DSCSA. Enacted in 2013 by the U.S. Food and Drug Administration, the DSCSA requires a unique federal traceability solution for...
by Nicolas Bohnet | Jan 31, 2017 | Blog
At the beginning of the millennium, product authentication was mainly done with a special tool or with the naked eye. The former solution was reliable but cumbersome while the later became less and less useful as simple copies became very good. Then, the smartphone...
by Nicolas Bohnet | Dec 23, 2016 | Blog
The European Commission recently published the 2015 Report on EU Customs Enforcement of Intellectual Property Rights.I While the number of cases (a ‘case’ refers to a detention that may contain one or more articles) dipped slightly in 2015 (95,194 in 2014 vs. 81,098...
by Nicolas Bohnet | Sep 30, 2016 | Blog
Although counterfeit medicines affect every region of the world, many drug-counterfeiting rings originate in Southeast Asian countries, such as Cambodia, Thailand, Laos, Vietnam, and China.I Many factors tend to bolster this situation, including weak enforcement, lack...
by Nicolas Bohnet | Jun 24, 2016 | Blog
Dated June 6, 2016, a “Roadmap” was published on June 9th on the EU Transparency Register covering implementing measures and delegated acts under Articles 15(11), 15(12) and 16(2) of the Tobacco Products Directive (TPD) 2014/40/EU.I In E.U. terms, “roadmaps” are...
