As a core element for verification, the Falsified Medicines Directive 2011/62/EU requires each pack to bear a so-called unique identifier. To ensure identification of the unique identifier on the pharmaceutical pack, this specification includes the requirements of the legislature and supplements it with the necessary technical details.
The current version 2.04a of 12 December 2018 was updated with the current requirements of the Delegated Regulation (EU) 2016/161 and complies with the currently known requirements of the national authorities.
- Coding Rules V2.04a (English | German)
- Changelog from Version 2.03 to Version 2.04a (English | German)
Free choice between PPN and NTIN
Pharmaceutical companies can choose between two different versions for printing the data matrix code for the German market. They can print it in compliance with the rules set out by IFA, using the Pharmacy Product Number (PPN) with the embedded national product code (PZN) as a globally unique product code. Alternatively, they may choose to print in compliance with the rules set out by GS1 Germany using the National Trade Item Number (NTIN) with the embedded national product code (PZN) as the globally unique product code. Both versions, PPN and NTIN, are derived from the same ISO standards, thereby ensuring the necessary compatibility and equivalent content of both versions.
Für more detailed information on both coding rules that can be used in the securPharm project, please visit:
Exemption from Indian Barcoding – How medicines due to serialization produces in India receive a correct coding according Delgated Regulation. Click here for more information.