Coding

As a core ele­ment of veri­fi­ca­ti­on, the Fal­si­fied Medi­ci­nes Direc­ti­ve 2011/62/EU sti­pu­la­tes that each pack must be pro­vi­ded with a uni­que iden­ti­fier. In order to ensu­re the iden­ti­fi­ca­ti­on of the uni­que iden­ti­fier on the phar­maceu­ti­cal packs, this spe­ci­fi­ca­ti­on repro­du­ces the requi­re­ments of the legis­la­tor and sup­ple­ments them with the neces­sa­ry tech­ni­cal details.

Free­dom of choice bet­ween PPN and NTIN

Phar­maceu­ti­cal manu­fac­tu­r­ers have the choice bet­ween two vari­ants of how they print the data in the Data Matrix Code. They can choo­se bet­ween the IFA spe­ci­fi­ca­ti­ons, using the Phar­ma­cy Pro­duct Num­ber (PPN) as the glo­bal­ly uni­que iden­ti­fier for the PZN, and the GS1 Ger­ma­ny spe­ci­fi­ca­ti­ons, using the Natio­nal Trade Item Num­ber (NTIN) as the glo­bal­ly uni­que iden­ti­fier for the PZN.

Path to an “Exemp­ti­on from Bar­co­ding” in India

How do medi­cinal pro­ducts sub­ject to seria­liza­ti­on manu­fac­tu­red in India obtain cor­rect coding in accordance with the Dele­ga­ted Regu­la­ti­on? Infor­ma­ti­on on the pro­ce­du­re and cont­act per­sons can be found here.