Safe­ty fea­tures

Dele­ga­ted Regu­la­ti­on (EU) 2016/161 requi­res two safe­ty fea­tures on the pack­a­ging of pre­scrip­ti­on drugs for human use:

• An anti-tam­­pe­ring device that makes it pos­si­ble to reco­g­ni­se whe­ther the outer pack­a­ging of a medi­cinal pro­duct is int­act. This safe­ty fea­ture must be imple­men­ted by each phar­maceu­ti­cal com­pa­ny its­elf. The ISO 21976 stan­dard pro­vi­des a uni­form inter­na­tio­nal stan­dard for this.
• A uni­que iden­ti­fier that makes each pack uni­que and uni­que­ly iden­ti­fia­ble via the pro­duct code it con­ta­ins. This uni­que iden­ti­fier is the basis for authen­ti­ca­ti­on by the secur­Ph­arm sys­tem. It con­sists of the pro­duct code (PC) and the seri­al num­ber (SN).
• In addi­ti­on to the plain text infor­ma­ti­on on the pack, the­re is also a Data Matrix Code (DMC), which con­ta­ins the fol­lo­wing infor­ma­ti­on:
  • Pro­duct Code (PC)
  • Seri­al num­ber (SN)
  • Batch desi­gna­ti­on
  • Expiry date.