Joint gui­de­lines for alarm hand­ling in Ger­ma­ny - Uni­form approach for more secu­ri­ty in the sup­p­ly chain

Frank­furt, Novem­ber 06, 2025 - The cor­rect and time­ly pro­ces­sing of alerts within the secur­Ph­arm sys­tem is a cen­tral com­po­nent of drug safe­ty in Ger­ma­ny. In order to stan­dar­di­ze the pro­ces­ses for all play­ers in the phar­maceu­ti­cal sup­p­ly chain, the secur­Ph­arm asso­cia­ti­on has now published nati­on­wi­de gui­de­lines for alarm pro­ces­sing(Ger­man | Eng­lish). The­se are based on the spe­ci­fi­ca­ti­ons of the ABDA (Fede­ral Uni­on of Ger­man Phar­macists’ Asso­cia­ti­ons) and the BAK (Fede­ral Cham­ber of Phar­macists) and are con­ti­nuous­ly deve­lo­ped in clo­se coope­ra­ti­on with both orga­niza­ti­ons.

Why stan­dar­di­zed gui­de­lines?

Alarms in the secur­Ph­arm sys­tem - for exam­p­le in the event of suspec­ted coun­ter­feit or tam­pe­red medi­ci­nes - requi­re a quick, struc­tu­red and com­pre­hen­si­ble pro­ce­du­re. Until now, howe­ver, the­re have been dif­fe­rent inter­pre­ta­ti­ons and pro­ces­ses among manu­fac­tu­r­ers, who­le­sa­lers, phar­maci­es and other par­ties invol­ved. The new gui­de­lines pro­vi­de cla­ri­ty here:

• Prac­ti­cal ins­truc­tions for action: Step-by-step pro­ce­du­re for typi­cal alarms such as dou­ble wri­te-offs or unknown packs - inclu­ding scan­ner tests and data recon­ci­lia­ti­on.
• Trans­pa­ren­cy and man­da­to­ry report­ing: Clear respon­si­bi­li­ties, report­ing chan­nels and docu­men­ta­ti­on obli­ga­ti­ons - imme­dia­te report­ing to aut­ho­ri­ties in the event of suspec­ted coun­ter­feit­ing.
• Auto­ma­ted sup­port: Alarm Manage­ment Sys­tem (AMS) auto­ma­ti­cal­ly ana­ly­zes, comm­ents on and clo­ses fal­se alarms - anony­mi­zed com­mu­ni­ca­ti­on bet­ween tho­se invol­ved.

Sup­port through new tools

secur­Ph­arm is deve­lo­ping prac­ti­cal tools to pro­vi­de addi­tio­nal sup­port for tho­se invol­ved in clas­si­fy­ing and pro­ces­sing alarms. A new tool in the AMS will go into test ope­ra­ti­on in the coming days to auto­ma­ti­cal­ly iden­ti­fy and clo­se low-risk alarms. “As soon as we have gai­ned solid expe­ri­ence with it, we will report on it in more detail,” explains secur­Ph­arm. The aim is to fur­ther sim­pli­fy the pro­ces­ses and make the respon­se to sus­pi­cious cases even more effi­ci­ent.

Recom­men­da­ti­on for imple­men­ta­ti­on

Com­pli­ance with the gui­de­lines is express­ly recom­men­ded, with the aim of ensu­ring that manu­fac­tu­r­ers, phar­maci­es, hos­pi­tals and who­le­sa­lers work tog­e­ther to clear up as many alerts as pos­si­ble and thus make an effec­ti­ve con­tri­bu­ti­on to pro­tec­ting against coun­ter­feit medi­ci­nes. “Uni­form alarm pro­ces­sing not only streng­thens pati­ent safe­ty, but also reli­e­ves the bur­den on com­pa­nies through clear pro­ces­ses,” empha­si­zes a secur­Ph­arm spo­kesper­son. “The gui­de­lines are a living docu­ment - we regu­lar­ly adapt them to new requi­re­ments and tech­ni­cal deve­lo­p­ments.”

Back­ground: Coope­ra­ti­on with the asso­cia­ti­ons and cham­bers

The gui­de­lines were deve­lo­ped in clo­se coope­ra­ti­on with the ABDA and the other mem­ber asso­cia­ti­ons and the Fede­ral Cham­ber of Phar­macists. This ensu­res that all par­ties invol­ved - from pro­duc­tion to dis­pen­sing in the phar­ma­cy - can act on the same basis. “Safe­ty comes from coope­ra­ti­on. With the­se gui­de­lines, we are taking ano­ther important step towards a coun­ter­feit-pro­of phar­maceu­ti­cal sys­tem in Ger­ma­ny,” says secur­Ph­arm.

Fur­ther infor­ma­ti­on

The gui­de­lines on alarm hand­ling are now available for down­load at www.securpharm.de

About secur­Ph­arm e.V.

secur­Ph­arm e.V. is the Ger­man orga­niza­ti­on for the authen­ti­ca­ti­on of medi­cinal pro­ducts. The asso­cia­ti­on is respon­si­ble for the ope­ra­ti­on of the sys­tem for the authen­ti­ca­ti­on of medi­cinal pro­ducts in accordance with the requi­re­ments of the Fal­si­fied Medi­ci­nes Direc­ti­ve 2011/62/EU and the Dele­ga­ted Regu­la­ti­on (EU) No. 2016/161. The aim is to pro­tect pati­ents in Euro­pe from fal­si­fied medi­cinal pro­ducts in the legal sup­p­ly chain. secur­Ph­arm e. V. is sup­port­ed by the fol­lo­wing phar­maceu­ti­cal and phar­macist asso­cia­ti­ons: BPI, Phar­ma Deutsch­land, vfa and ABDA. secur­Ph­arm is the Ger­man com­po­nent of the EU-wide EMVS net­work against coun­ter­feit medi­ci­nes - for more safe­ty from pro­duc­tion to the pati­ent. Its stra­te­gic part­ners in the imple­men­ta­ti­on are ACS and NGDA.