The new rules on safety features on the packaging of medicinal products have taken effect

On 9 February 2019, the EU Regulation on measures for the prevention of falsified medicinal products and the amendments to the Executive Order on Labelling etc. of Medicines entered into force.

With the Commission Delegated Regulation (EU) 2016/161, the EU has adopted new rules on safety features placed on the packaging of medicinal products in order to prevent falsified medicinal products from entering the legal supply chain. The regulation requires the placement of safety features on the packaging of medicinal products in the form of an anti-tampering device that shows whether the packaging has been opened, as well as a unique identifier for the identification and authentication of the individual packaging. In connection with the new Regulation, Denmark has amended the Executive Order on Labelling etc. of Medicines (see new Section 14 and Section 17(2)-(5)).

The new rules entail that it is required to place an anti-tampering device and a unique identifier on the packaging of medicinal products for human use subject to prescription and the packaging of medicinal products not subject to prescription as well as categories of medicinal products set out in Annex II to the Regulation.

The manufacturer may also choose to place an anti-tampering device on the packaging of medicinal products subject to prescription and categories of medicinal products set out in Annex I to the Regulation, if the manufacturer assesses that an anti-tampering device would decrease the risk of falsification. The manufacturer is not allowed to place a unique identifier on this category of medicinal products.

Additionally, the manufacturer may choose to place an anti-tampering device on the packaging of medicinal products not subject to prescription and categories of medicinal products not listed in Annex II to the Regulation, if the manufacturer has made the same risk assessment as mentioned above. In relation to this category of medicinal products, the manufacturer is required to place a unique identifier on the packaging.

The manufacturer has to encode the unique identifier in a two-dimensional barcode. Said barcode should at least comprise the product code, the serial number, the batch number and the expiry date. The information has to be uploaded to the joint European repositories system before releasing the medicinal product for sale or distribution.

The new rules are part of the European Union's measures to prevent the falsification of medicinal products for the purpose of patient safety in the EU.

We have previously mentioned the new EU rules:
"Rules on prevention of falsified medicines - safety features"

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