Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation

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18 June 2024
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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 by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use" in the official journal of the European Union.

The most important consequence of this publication is that the date for the implementation of the required measures is now mandatory: all requirements must be implemented by 9th February 2019! This means that the delegated regulation for serialization and verification of the medicinal products concerned must be applied starting 9th February 2019.

The final regulation remained almost completely unchanged compared to the draft of this regulation. Compare our news "Draft of Delegated Act regarding Safety Features published".

Only in the scope in article 2 a further paragraph 1.c) has now been supplemented that this regulation also applies to medicinal products on which the member states have extended the scope of application of the unique identifier or of the device against manipulation in accordance with article 54a (5) of Directive 2001/83/EC. And in article 9 on bar codes on the packaging a sentence was switched without having any effect, though.

With the publication of this regulation, 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.

Article 6, for example, defines the minimum requirements for the print quality of these two-dimensional bar codes and parameters, which the manufacturer must check in the future.

To get the detailed information please see the original COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.