Faller – Implementation of the Delegated Regulation (EU) 161/2016

The Delegated Regulation (EU) 161/2016 specifies that medications subject to prescription and certain OTC products must be furnished with a 2D data matrix code. In addition, the product code, the serial number and the national cost reimbursement number must be displayed on the packaging in a format that can be easily read

GERMANY • The counterfeiting of medications is a major challenge within the pharmaceutical industry, to which legislative authorities react with increasing statutory requirements. The new Delegated Regulation (EU) 161/2016 will apply by February 2019, which, besides serialisation requirements, demands additional anti-tampering devices for drug packaging. Faller, as a solution partner to the pharmaceutical industry, is supporting its customers in the proper implementation of these regulations. The specialist for pharmaceutical packaging solutions has drafted a white paper that describes the most important features and requirements of what is known as the Falsified Medicine Directive.

Serialisation in accordance with delegated acts


In accordance with the new Delegated Regulation (EU) 161/2016, pharmaceutical manufacturers who distribute their products in Europe must, in the future, assign prescription medications and OTC products with a serial code as a unique identification feature, save this serial number and transfer it to a Europe-wide database under the tightest security requirements. The security code specified by the EU is a 2D data matrix code that ensures traceability along the entire supply chain.

Whether in the EU, China or Turkey – most codes are the same in terms of their structure and composition. Faller is able to print all codes required worldwide or, such as for Bollini labels, enable adhesive labels and folding cartons to be combined. With the aid of state-of-the-art technologies and various inspection stages, the pharma packaging specialist guarantees a 100% quality control of its products with the serial coding.

 Data handling with solution providers

The Delegated Regulation (EU) 2016/161 requires that the serial numbers are saved in a Europe-wide database. The mainly cloud-based platforms of the so-called solution providers must fulfil the requirements of the regulation concerning serialisation and traceability. The concepts are supposed to ensure the transfer of the relevant data into the national systems using one single platform. This service simplifies the handling of complex data structures while observing the corresponding compliances. Using these cloud solution, serialisation takes place with the utmost security while abiding by the respective regulatory requirements. Faller uses these clouds on behalf of the pharmaceutical companies and therewith ensures a secure data handling along the supply chain already when printing the codes for their customers.

 Protection against medication counterfeiting

In order to combat counterfeiting, the EU regulation also provides for anti-tampering devices (tamper evidence) for medication packaging. Faller offers tamper-evident seals for pharmaceutical secondary packaging as well as label solutions for folding cartons. This includes various label solutions, which can be furnished with special features such as concealed images, imprinted serialised data or codes. To assist pharmaceutical manufacturers in implementing the Delegated Regulation (EU) 161/2016, August Faller GmbH & Co KG has summarised all of the major requirements in a white paper that is available for download on the company’s website.

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