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COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 published by the European Union on 9th February 2016

On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council which now includes detailed rules for the safety features appearing on the packaging of medicinal products for human use".

The most important change is that date for the implementation of the required measures is now mandatory which means that the delegated regulation for serialization and verification of the medicinal products concerned must be applied starting 9th February 2019.

The major changes include:


• a two dimensional barcode (2D barcode) will have to be used as a safety feature in the future. This must be applied on the packaging in readable form.
• The regulation now defines the minimum requirements for the print quality of these two-dimensional bar codes and parameters, which the manufacturer must check in the future.


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