Ash Ramzan’s latest article has just been published in the latest edition of the TOPRA Regulatory Rapporteur, ( Vol. 14, No 4, April 2017) entitled “The Falsified Medicines Directive – What does it really mean for stakeholders?”.
“The Falsified Medicines Directive (FMD, 2001/83/EC as amended to 2011/62/EU) and its Delegated Regulation EU 2016/161 sets out the overall requirements that manufacturers of human medicinal products must meet as part of their legal responsibility. These responsibilities also extend to wholesalers, dealers and parallel importers. While it is widely known that all of the aspects of the FMD will come into force by 9 February 2019, the preceding (and related) requirements that have either already been implemented, or are in the process of being implemented, are less well understood. This article serves to provide an overview and history of the Directive as well as including its key requirements, and how There is wide variability in the approaches being taken and the pace of progress, but one certainty remains; this Directive will be enforced for all manufacturers intending to supply human medicines into the EU”
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