Coding rules

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:

• Infor­ma­ti­ons­stel­le für Arz­nei­spe­zia­li­tä­ten (IFA) for the PPN
• GS1 Ger­ma­ny GmbH for the NTIN

Exemp­ti­on from Indi­an Bar­co­ding – How medi­ci­nes due to seria­liza­ti­on pro­du­ces in India recei­ve a cor­rect coding accor­ding Del­ga­ted Regu­la­ti­on. Click here for more infor­ma­ti­on.