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.
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 Barcoding – How medicines due to serialization produces in India receive a correct coding according Delgated Regulation
Many pharmaceutical companies in the German medicine market receive from associated companies or contract manufacturers prescription medicines which are produced and packed in India. India already introduced several years ago a track und trace system for export medicines, which require amongst others a labelling with a data matrix code on the secondary packaging, in which is coded the product code, batch name, expiry date and a serial number. The data themselves are additionally printed in plain text on the packaging and additionally for the German market with the
Pharmazentralnummer (PZN) in code 39 and in plain text as well for reimbursement purposes.
With the commencement of the Delegated Regulation (EU) 2016/161 it may come to conflicts especially on the German market, due to the fact the Indian coding comes close the European requirements, but not fulfill every aspect. The securPharm coding rules require for packages sold on the Germany market only, that the product code, as embedded PZN, is whether printed as a NTIN (National Trade Item Number according GS 1 standard) or as PPN (Pharmacy Product Number according ACS format of the IFA). The Indian coding stipulates a GTIN (according GS 1 standard), which will be rejected by some European countries and also by the Germany system.
If you as pharmaceutical company are affected by this problem, we kindly ask you to get in touch with your Indian partner. There is a solution for the problem:
Please request your Indian partner to apply for an exemption from barcoding in case he still not acted so far. Right now, already 38 Indian companies received an exemption for the delivery of countries in the European Union.
With this exemption the Indian manufacturer don’t have to fulfill the Indian export coding requirements, but only have to realize the Coding Requirements of the EMVO and especially the Coding rules for the Germany market issued by securpharm.
Contact in India
Pharmaceuticals Export Promotion Council of India (Pharmexcil)
Head Office: 101, Aditya Trade Centre
Ameerpet, Hyderabad 500038
|Phone:||+91 40 23735462/66|
|Fax:||+91 40 23735464|
Additional information regarding barcoding