Serialization for: Pharmaceutical industry (EU: 2016/161) · Agrochemicals (Cristal) · Medical technology (UDI)
Delegated Regulation (EU)
The Delegated Regulation (EU) 2016/161 of the Commission supplementing Directive 2001/83/EC on preventing the entry of falsified medicinal products into the legal supply chain requires a “unique identifier“ for identification and verification of the authenticity as well as an “anti-tampering device“ for all prescription medicines. <br/>”The Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC on forgery protection must have been implemented by February 2019, by most of the EU member states.”
The JetSerial®-System is
- the “unique identifier“
- the “anti-tampering device“
- and your “data interface“
Jet-Serial is the combination of a security seal as “anti-tampering device“ printed with the data of the “unique identifier” in conjunction with the client/server solution for simple implementation.
The company HED Serial is
a cooperation project of HED GmbH Haftetikettendruck with Verpackungstechnik Jetter GmbH. In HED GmbH Haftetikettendruck you will have a reliable and strong partner that has supplied the market with top-quality labels in the second generation already.
Verpackungstechnik Jetter GmbH is a specialist and innovator in the pharmaceutical packaging sector. . . .
simple . . .
1. At HED Serial we produce security seals for you fitting your folding box formats.
2. You ask us for a run of serialized security seals in accordance with the data of your packaging order.
3. We deliver the labels to the place of destination specified by you.
4. We send you the dataset of the security seals delivered to you on rolls.
. . . effizient . . .
means for you:
1. You send your data to one interface only, no matter if you process the security seals yourself or if you have asked a contract manufacturer to do so.
2. You or your contract manufacturer need not worry about the quality of the print and the legibility of the labels.
3. You or your contract manufacturer only need one labelling unit and one device for reading the 2D codes.
4. You or your contract manufacturer record the data of the manufactured packaging at the end of the packaging line.
5. You compare the data of the manufactured packages with the dataset of printed security seals returned to you by us.
. . . safe
1. You need one defined, secure interface to HED Serial only and can thereby implement the serialization with all of your previous contract manufacturers.
2. You are in control of all serialization numbers that have not been processed or of those lost as rejects by comparison of our dataset with the packaging data recorded at the end of the packaging line.
3. The printing quality on our Jet-Serial security seals is verified by cameras at our facility and always exceeds the valid requirements.