Mapping Out the Tobacco Products Directive

Mapping Out the Tobacco Products Directive

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...
What Do Pharma Safety Regulations Look Like in the U.S.?

What Do Pharma Safety Regulations Look Like in the U.S.?

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...
FMD Delegated Regulation (EU) 2016/161 Published

FMD Delegated Regulation (EU) 2016/161 Published

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...