Aut­ho­ri­ties

Role in the sys­tem

The natio­nal aut­ho­ri­ties moni­tor the func­tio­ning of the data repo­si­to­ries and inves­ti­ga­te poten­ti­al cases of suspec­ted coun­ter­feit­ing whe­re hand­ling errors and tech­ni­cal faults could pre­vious­ly be ruled out. In addi­ti­on, the usu­al offi­ci­al moni­to­ring of mar­ket par­ti­ci­pan­ts for com­pli­ance with the Fal­si­fied Medi­ci­nes Direc­ti­ve and the Dele­ga­ted Regu­la­ti­on will be exten­ded.

Pos­si­bi­li­ties

• Crea­ti­on of audit trails for indi­vi­du­al packs
• Pro­vi­si­on of over­views of the acti­vi­ties of indi­vi­du­al play­ers
• Dis­play of infor­ma­ti­on on acti­ve and inac­ti­va­ted packs of cer­tain pro­ducts
• Dis­play of infor­ma­ti­on on inac­ti­ve actors
• Track­ing the rela­ti­onships bet­ween ori­gi­nal and repacka­ged bat­ches

cos­ts

• Use of the secur­Ph­arm sys­tem is com­ple­te­ly free of char­ge for aut­ho­ri­ties
• Use wit­hout spe­cial hard­ware thanks to com­pa­ti­bi­li­ty with stan­dard hard­ware

Bene­fits

• Pro­vi­si­on of rele­vant infor­ma­ti­on to sup­port inspec­tions
• Sup­port in the inves­ti­ga­ti­on of suspec­ted coun­ter­feit­ing cases
• Ensu­ring the tracea­bi­li­ty of all acti­vi­ties of the actors

Pre­re­qui­si­tes

• Sig­ning of the aut­ho­ri­ty con­tract
• Use of the latest ver­si­on of one of the fol­lo­wing Inter­net brow­sers:
  • Fire­fox
  • Chro­me
• Access to the fol­lo­wing web­sites:
  • https://portal-prod-de.nmvs.eu
  • https://portal-pki-prod-de.nmvs.eu
• Ensu­re that port 443 is open for use
• Instal­la­ti­on of a PFX/P12 cer­ti­fi­ca­te on the local com­pu­ter
• Access to your per­so­nal, busi­ness e-mail address at your aut­ho­ri­ty.

Inter­nal area