On 09.02.2016, the European Union has published the delegated Regulation (EU) No. 2016/161, which lays down the requirements for the implementation of the Counterfeiting Directive 2011/62 / EU. It states that as of 02 February 2019, only prescription medicines may be marketed if they comply with the new safety features of the Directive.

We help you to implement this policy and equip your prescription medicines with the relevant characteristics.

Since 2018, the company has also been offering the legally required serialisation for prescription-only medicines in compliance with Directive 2011/62/EU and the associated regulations. The serialisation modules work with pre-configured sFTP interfaces to all common providers.

The system takes into account the different target markets of the medicinal products; special characters and different font types can also be covered. A complete track & trace process with the aid of serialisation represents the best possible control.

For legally compliant tamper protection, the Tamper Evident labeller applies round or rectangular security seals over the side flaps of the folding boxes. The adhesive used for this purpose is highly resistant to heat, moisture and various solvents and thus cannot be removed without leaving residues even from heavily lacquered folding boxes.

Figure: Module for in-line or off-line printing and verification on up to 3 pages, top and tamper evident labeling