Serialization – FMD Compliance
We protect you, your products and your customers from counterfeit medicines and produce in accordance to the European Falsified Medicines Directive (FMD)!
Since 9th of February 2019, three years after the publication of the EU-wide Act 2011/62, prescription medicines can only be marketed in the EU if they meet the requirements of the European Falsified Medicines Directive. From now on, all affected prescription medicines must be labeled with a so-called Unique Identifier (2D Data Matrix Code including serial number) in connection with individual production data (product identification GTIN / NTIN / PPN, expiry date and batch number) on each folding box. This distinctive labeling makes each packing unit clearly identifiable and traceable throughout Europe Union. In addition, each packing unit is sealed with Tamper Evident labels, as a first opening protection. Pharmacies are required to electronically check these new security features in order to ensure that only original products, which were officially released for market sales, are hand over to the end customer. Hence, the primary goal of this EU directive is to improve the protection of patients by preventing the entry of counterfeits into the legal supply chain of pharmaceuticals. Similar and sometimes even more extensive regulations apply in many countries of the world or are in preparation.
To meet these requirements for pharmaceutical companies, we have prepared ourselves in many ways. Especially, as the pharmacy authentication check requires the information exchange across the entire supply chain. These requirements can therefore only be met by the interaction of intelligent track and trace production machines, high-performance IT and respectively aligned quality-oriented processes.
On the one hand, we have added to our modular line design Traceable Quality Systems, which combine the following functions:
- 1) Serialization: Creation, application and verification of unique identifiers on each folding box
- 2) Tamper-Evident labelling: Sealing of the insertion flaps with Tamper-Evident labels on each folding box
- 3) Quality checks: Digital verification of printing, the proof of tamper evident labelling as well as weight control takes place during production of each folding box
On the other hand, we have invested into software solution in order to ensure the best possible information exchange of the serialization information throughout the entire value chain. We are able to generate and manage the respective information as well as to distribute it either via respective service providers or directly to the securPharm database.
You see, we are well prepared! Do not hesitate to contact us with further questions.