Falsified Medicines Directive - Compliance date confirmed

Compliance date confirmed as 9th February 2019

FINALLY- The Delegated Acts on safety features (EU FMD), adopted on 2 Feb. 2016, were published in the Official Journal of the EU. You can click here to access them.

The deadlines for implementation of the requirements will be on 9 Feb. 2019 and 6 years after for Belgium, Italy and Greece.

The EU Falsified Medicines Directive (FMD) which seeks to establish a more secure supply chain for the distribution of prescribed medicines will require the serialisation of patient packs to include a 2D barcode on all patient packs which are to be scanned at the point of dispense for verification purposes. The legislation also requires tamper evident labelling to enable the authentication of medicines prior to being dispensed to patients. The proposed European and existing US FDA Unique Device Identification (UDI) regulations includes the labelling of all medical devices with an internationally recognised unique identifier and barcode and registering this device in the FDA database.

Both pharmaceutical and medical device manufacturers are leveraging GS1 standards and the support of GS1 experts, to prepare for these new requirements and ensure regulatory compliance. Many of these organisations are also deriving additional value from improved traceability based on GS1 standards.

To read more see my article in the 2016 Pharmachem Yearbook, which you can read by clicking here.