The secur­Ph­arm sys­tem

Struc­tu­re as an end-to-end sys­tem

The secur­Ph­arm sys­tem is based on the end-to-end prin­ci­ple, in which both ends of the logi­stics chain are used for pro­tec­tion. One end is the phar­maceu­ti­cal com­pa­ny that places a medi­ci­ne on the mar­ket. The other end is the dis­pen­sing point, such as a public phar­ma­cy.

The Ger­man veri­fi­ca­ti­on sys­tem is embedded in a Euro­pean net­work to ensu­re pati­ent pro­tec­tion across bor­ders. The EU hub, ope­ra­ted by the Euro­pean Medi­ci­nes Veri­fi­ca­ti­on Orga­niza­ti­on (EMVO ), ensu­res the exch­an­ge of data bet­ween the mem­ber sta­tes of the EU, the EEA and Switz­er­land.

The authen­ti­ca­ti­on pro­cess

During the pro­duc­tion pro­cess, the phar­maceu­ti­cal com­pa­ny appli­es the safe­ty fea­tures to each pack of a medi­cinal pro­duct. The data of the uni­que iden­ti­fier (seri­al num­ber, pro­duct code, batch num­ber, expiry date) is appli­ed to the pack in plain text and in the Data Matrix Code and uploa­ded to the cen­tral data­ba­se of the phar­maceu­ti­cal indus­try. The Data Matrix Code is scan­ned to check authen­ti­ci­ty befo­re it is dis­pen­sed to the pati­ent. This com­pa­res the data on the pack with the data in the sys­tem. The sta­tus of the pack is repor­ted back to the phar­ma­cy, i.e. whe­ther the uni­que iden­ti­fier has been acti­va­ted or deac­ti­va­ted. If the lat­ter is the case - for exam­p­le becau­se the pack with this fea­ture has alre­a­dy been dis­pen­sed - the pack may not be dis­pen­sed to the pati­ent. The inci­dent is then che­cked. If the iden­ti­fi­ca­ti­on fea­ture is acti­va­ted, the medi­ci­ne may be dis­pen­sed.

How does the sys­tem pro­tect against coun­ter­feit­ing?

The Euro­pean pro­tec­tion sys­tem makes it easier to detect coun­ter­feit medi­ci­nes in the legal sup­p­ly chain, as each seri­al num­ber can only be used once. The seri­al num­ber in com­bi­na­ti­on with the pro­duct code and batch num­ber also makes it pos­si­ble to trace whe­re a coun­ter­feit medi­ci­ne ente­red the legal sup­p­ly chain. In the case of sto­len goods, the seri­al num­ber can be blo­cked in the sys­tem so that the goods can no lon­ger be han­ded over.

Strict data sepa­ra­ti­on

For reasons of data pro­tec­tion, the secur­Ph­arm sys­tem works with sepa­ra­te sys­tems for phar­maceu­ti­cal com­pa­nies (data­ba­se sys­tem of the phar­maceu­ti­cal indus­try) and drug dis­pen­sing orga­niza­ti­ons (phar­ma­cy sys­tem). Veri­fi­ca­ti­on requests are bund­led via the phar­ma­cy sys­tem and for­ward­ed anony­mously to the data­ba­se sys­tem of the phar­maceu­ti­cal indus­try. The sub­sys­tems are ope­ra­ted by our stra­te­gic part­ners NGDA (phar­ma­cy sys­tem) and ACS (data­ba­se sys­tem of the phar­maceu­ti­cal indus­try).