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Less than a month until February 9, 2019! Delegated Regulation (EU) 2016/161 for the serialization of medicines!

Less than a month until February 9, 2019! Delegated Regulation (EU) 2016/161 for the serialization of medicines!

Following Directive 2011 / 62UE and Delegated Regulation 2016/161 establishing a set of detailed rules for the safety elements appearing on the packaging of medicinal products for human use, the latter will have a unique identification code and a device for identification protection against unlawful changes.

This decision was made following the alarming increases of falsification of medicines, so it was decided to eliminate even the fractions from the boxes of medicines, a practice that was only allowed in Romania.

As of February 9, 2019, only prescription drugs that carry the new safety features to be tracked and verified throughout the production and sales chain (Track & Traceability) will be released.

After February 9, 2019, boxes of medicines that do not have the safety elements required by Delegated Regulation (EU) 2016/161 will NOT be able to be included in the circuit.

The autoID digital solutions proposed by Total Technologies® for drug testing to support all traders in the pharmaceutical industry are: ScanPal EDA51 and Voyager 1450g
These offer the possibility of scanning both 2D and 1D barcodes, being a low-cost investment.