Tento dokument sumarizuje sk\u00fasenosti a\u202fk\u013e\u00fa\u010dov\u00e9 zistenia vypl\u00fdvaj\u00face z\u202fmetodick\u00e9ho pokynu \u0160t\u00e1tneho \u00fastavu pre kontrolu lie\u010div (\u0160\u00daKL) k syst\u00e9mu eKolok a\u202fz\u202fdotazn\u00edka Slovenskej asoci\u00e1cie spolo\u010dnost\u00ed v oblasti liekovej regul\u00e1cie (SARAP) zameran\u00e9ho na sk\u00fasenosti s t\u00fdmto platobn\u00fdm port\u00e1lom. Cie\u013eom SARAP je na z\u00e1klade t\u00fdchto zisten\u00ed vies\u0165 \u010fal\u0161iu diskusiu so \u0160\u00daKL a Slovenskou po\u0161tou za \u00fa\u010delom zlep\u0161enia a\u202fzjednodu\u0161enia platieb.<\/p>\n
V tomto dokumente sa pojmom eKolok mysl\u00ed platba cez elektronick\u00fd kolok aj prostredn\u00edctvom platobn\u00e9ho predpisu.<\/p>\n
\u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div (\u0160\u00daKL) je od 1. septembra 2024 zapojen\u00fd do Centr\u00e1lneho syst\u00e9mu evidencie poplatkov (CSEP), ktor\u00fd prev\u00e1dzkuje Slovensk\u00e1 po\u0161ta, a.s. Tento syst\u00e9m umo\u017e\u0148uje \u00fahradu spr\u00e1vnych poplatkov za \u00fakony a konania \u0160\u00daKL prostredn\u00edctvom slu\u017eby \u201eeKolok\u201c.<\/p>\n
Na module SARAP (2. j\u00fana 2026) bola diskutovan\u00e1 t\u00e9ma platieb cez eKolok, pri\u010dom viacer\u00ed \u010dlenovia vyjadrili nespokojnos\u0165 a obavy, \u017ee platby prostredn\u00edctvom Slovenskej po\u0161ty m\u00f4\u017eu naru\u0161i\u0165 valid\u00e1ciu podanej zmeny alebo schv\u00e1lenia klinickej \u0161t\u00fadie. v reakcii na to SARAP vytvoril dotazn\u00edk s otvorenou ot\u00e1zkou (\u201ePop\u00ed\u0161te va\u0161u sk\u00fasenos\u0165\u201c<\/em>) a\u00a0mo\u017enos\u0165ou hodnotenia funk\u010dnosti syst\u00e9mu eKolok na stupnici 1-5, pri\u010dom 5 bolo najlep\u0161ie. V\u00fdstupy dotazn\u00edka s\u00fa pou\u017eit\u00e9 na vytvorenie tohto dokumentu a\u00a0bud\u00facu diskusiu so \u0160\u00daKL a Slovenskou po\u0161tou za \u00fa\u010delom zlep\u0161enia a zjednodu\u0161enia platieb.<\/p>\n Asoci\u00e1cia SARAP dostala 29 odpoved\u00ed<\/strong> od 24 \u010dlenov<\/strong> – dr\u017eite\u013eov registr\u00e1cie liekov (\u010falej len MAH) alebo ich z\u00e1stupcov v priebehu j\u00fana a j\u00fala 2026. Prieskum odhalil zmie\u0161an\u00e9 sk\u00fasenosti s platobn\u00fdm port\u00e1lom. Priemern\u00e9 hodnotenie funk\u010dnosti bolo pribli\u017ene 3,6 z\u00a05,0<\/strong>.<\/p>\n Celkovo mo\u017eno kon\u0161tatova\u0165 nasledovn\u00e9:\u00a0<\/p>\n V kombin\u00e1cii s intern\u00fdmi nastaveniami MAH \u2013 kde sa ak\u00e1ko\u013evek platba hrad\u00ed bankov\u00fdm prevodom a nie je mo\u017en\u00e9 ju okam\u017eite uhradi\u0165 platobnou kartou<\/strong>, dlh\u00fdmi intern\u00fdmi administrat\u00edvnymi procesmi spracovania platby, s\u00a0pevne ur\u010den\u00fdmi rozvrhmi platobn\u00fdch kalend\u00e1rov, sa m\u00f4\u017ee sta\u0165, \u017ee sa platba nestihne uhradi\u0165 v\u010das a\u00a0Slovensko zabrzd\u00ed valid\u00e1ciu \u017eiadosti o\u00a0zmenu alebo klinick\u00e9 sk\u00fa\u0161anie v\u00a0r\u00e1mci E\u00da.<\/p>\n eKolok s\u00edce umo\u017e\u0148uje aj \u00fahradu vopred, e\u0161te pred podan\u00edm \u017eiadosti (pozri \u010das\u0165 5), av\u0161ak to si vy\u017eaduje, aby MAH presne vypo\u010d\u00edtal poplatok (bez mo\u017enej konzult\u00e1cie so \u0160\u00daKL), zak\u00fapil eKolok na pobo\u010dke po\u0161ty alebo cez webov\u00e9 rozhranie a uhradil ho v hotovosti alebo platobnou kartou. Vopred zak\u00fapen\u00fd eKolok nie je mo\u017en\u00e9 uhradi\u0165 prevodom<\/strong>. Iba minimum MAH m\u00e1 mo\u017enos\u0165 hradi\u0165 platby inak ako prevodom.<\/p>\n Platnos\u0165 eKolku zak\u00fapen\u00e9ho prostredn\u00edctvom internetu je obmedzen\u00e1 na 30 dn\u00ed. v pr\u00edpade posunu term\u00ednov podan\u00ed zo strany MAH tak vznik\u00e1 riziko, \u017ee jeho platnos\u0165 uplynie e\u0161te pred podan\u00edm \u017eiadosti. \u010eal\u0161\u00edm probl\u00e9mom je situ\u00e1cia, ke\u010f poplatok vypo\u010d\u00edtan\u00fd \u0160\u00daKL nezodpoved\u00e1 hodnote eKolku alebo zvolenej slu\u017ebe, pr\u00edpadne ak sa na posledn\u00fa chv\u00ed\u013eu zmen\u00ed po\u010det alebo typ zmien. v takom pr\u00edpade mus\u00ed MAH eKolok vr\u00e1ti\u0165 a zak\u00fapi\u0165 nov\u00fd, pr\u00edpadne \u010daka\u0165 na vystavenie platobn\u00e9ho predpisu, \u010do cel\u00fd proces administrat\u00edvne predl\u017euje.<\/p>\n V\u0161eobecn\u00fdm zisten\u00edm prieskumu je:\u00a0<\/p>\n Pozit\u00edvne zistenia:\u00a0<\/p>\n V\u00fdzvy a negat\u00edvne sk\u00fasenosti:\u00a0<\/p>\n Na z\u00e1klade z\u00edskan\u00fdch d\u00e1t a sp\u00e4tnej v\u00e4zby od \u010dlenov SARAP je mo\u017en\u00e9 identifikova\u0165 nieko\u013eko k\u013e\u00fa\u010dov\u00fdch oblast\u00ed pre zlep\u0161enie fungovania syst\u00e9mu eKolok a s\u00favisiacich procesov \u0160\u00daKL a Slovenskej po\u0161ty:\u00a0<\/p>\n Pri odpovediach sa rozli\u0161ovali typ slu\u017eby a odkia\u013e sa za \u0148u plat\u00ed.<\/p>\n Typ slu\u017eby:\u00a0<\/p>\n \u00dahrada platby zo:\u00a0<\/p>\n Typ slu\u017eby: Registr\u00e1cia\/Pred\u013a\u017eenie registr\u00e1cie\/Prevod registr\u00e1cie\/Ozn\u00e1menia a zmeny v registr\u00e1cii lieku<\/strong><\/p>\n Platbu uhr\u00e1dzate zo: Slovenska<\/strong>\u00a0<\/p>\n Jednoduchos\u0165 a bezprobl\u00e9movos\u0165 \u00fahrady: \u201eV\u0161etko funguje ako m\u00e1, nezaznamenali sme \u017eiadne probl\u00e9my s \u00fahradou.\u201c<\/em> (MAH04). \u201eProces platby nie je zlo\u017eit\u00fd a\u00a0platobn\u00fd predpis sa \u00fa\u010dtuje ako in\u00e9 fakt\u00fary\u201c<\/em> (MAH03).<\/p>\n Dostato\u010dn\u00e1 doba splatnosti a bezprobl\u00e9mov\u00e9 p\u00e1rovanie: Doba splatnosti 30 dn\u00ed je dostato\u010dn\u00e1 a nie s\u00fa probl\u00e9my so sp\u00e1rovan\u00edm platby (MAH05, MAH03).<\/p>\n Mo\u017enos\u0165 vr\u00e1tenia: \u201e\u017diadali sme u\u017e aj o vr\u00e1tenie poplatku a aj tam to prebehlo bez probl\u00e9mov.\u201c<\/em> (MAH13).\u00a0<\/p>\n Ch\u00fdbaj\u00face potvrdenie o prijat\u00ed platby: \u201eOcenili by sme, ak by n\u00e1m pri\u0161lo potvrdenie o\u00a0prijat\u00ed platby.\u201c<\/em> (MAH04). Uv\u00edtalo by sa e-mailov\u00e9 potvrdenie o prijat\u00ed a sp\u00e1rovan\u00ed platby pre istotu (MAH23), aj ke\u010f niekomu \u201ev\u00fdrazne nech\u00fdba\u201c<\/em> (MAH03).<\/p>\n Riziko oneskorenia kv\u00f4li intern\u00fdm procesom: Intern\u00e9 pravidl\u00e1 pre schva\u013eovanie platieb m\u00f4\u017eu trva\u0165 dlh\u0161ie, \u010do m\u00f4\u017ee vies\u0165 k tesnej \u00fahrade (MAH05, MAH14). Platby, pri ktor\u00fdch platobn\u00fd pr\u00edkaz zo \u0160\u00daKL pr\u00edde v stredu poobede alebo vo \u0161tvrtok, s\u00fa rizikov\u00e9 z h\u013eadiska v\u010dasnej \u00fahrady (MAH03).<\/p>\n Nedostato\u010dn\u00e9 inform\u00e1cie pri vr\u00e1ten\u00ed platby: Slovensk\u00e1 po\u0161ta neuv\u00e1dza, za ktor\u00fd VS sumu vracia, ani \u017eiadne dopl\u0148uj\u00face \u00fadaje, \u010do znemo\u017e\u0148uje sp\u00e1rovanie vr\u00e1tenej sumy s p\u00f4vodn\u00fdm platobn\u00fdm pr\u00edkazom, najm\u00e4 pri vr\u00e1ten\u00ed viacer\u00fdch poplatkov (MAH11).<\/p>\n Platbu uhr\u00e1dzate zo: zahrani\u010dia<\/strong><\/p>\n Jednoduch\u00e9 a r\u00fdchle zadanie platby: \u201eZadanie platby je jednoduch\u00e9. Platba sa realizuje r\u00fdchlo.\u201c<\/em> (MAH06). Intern\u00e9 nastavenie platieb vo firm\u00e1ch m\u00f4\u017ee zabezpe\u010di\u0165 bezprobl\u00e9mov\u00e9 \u00fahrady (MAH17).<\/p>\n Dostato\u010dn\u00e1 doba splatnosti a bezprobl\u00e9mov\u00e9 p\u00e1rovanie: Doba splatnosti 30 dn\u00ed je vyhovuj\u00faca\/posta\u010duj\u00faca (MAH06, MAH10, MAH16, MAH17, MAH18, MAH20). Probl\u00e9my so sp\u00e1rovan\u00edm platby sa nevyskytli u viacer\u00fdch MAH (MAH06, MAH09, MAH18).<\/p>\n Invalid\u00e1cia \u017eiadost\u00ed aj pri dodr\u017ean\u00ed splatnosti a neistota platby: \u0160\u00daKL automaticky invaliduje \u017eiados\u0165, hoci platby sa m\u00f4\u017eu vykona\u0165 do 30 dn\u00ed, pri\u010dom \u201eu\u017e na druh\u00fd de\u0148 svieti invalid\u201c<\/em> (MAH07). Ch\u00fdbaj\u00faca inform\u00e1cia o prijat\u00ed platby vedie k tomu, \u017ee dr\u017eitelia nevedia, \u010di platba bola prijat\u00e1, a \u010dasto sa to zist\u00ed a\u017e na konci proced\u00fary s invalidn\u00fdm statusom (MAH10, MAH20, MAH22).<\/p>\n Probl\u00e9my s E2E referenciou a n\u00e1ro\u010dnos\u0165 \u00fahrad: Komplik\u00e1ciu predstavuje povinn\u00e1 alfanumerick\u00e1 E2E referencia pri platb\u00e1ch zo zahrani\u010dn\u00e9ho \u00fa\u010dtu (\u010d\u00edseln\u00fd VS neposta\u010duje), pri\u010dom niektor\u00e9 banky zadanie tohto \u00fadaju nepodporuj\u00fa (MAH10, MAH17, MAH22). Niektor\u00ed v\u0161ak tento probl\u00e9m interne vyrie\u0161ili (MAH12). Cel\u00fd aktu\u00e1lny platobn\u00fd proces je administrat\u00edvne a \u010dasovo pomerne n\u00e1ro\u010dn\u00fd (MAH10).<\/p>\n Komplikovan\u00e9 intern\u00e9 procesy vo ve\u013ek\u00fdch firm\u00e1ch: Platby zo zahrani\u010dia s\u00fa komplikovan\u00e9 kv\u00f4li zlo\u017eit\u00fdm intern\u00fdm syst\u00e9mom ve\u013ek\u00fdch firiem (MAH07, MAH20).<\/p>\n Zd\u013ahav\u00fd a problematick\u00fd proces vr\u00e1tenia platby: Proces \u017eiadania o vr\u00e1tenie platby bol na Slovenskej po\u0161te ve\u013emi zd\u013ahav\u00fd a zamestnanci nevedeli, ako spracova\u0165 \u017eiados\u0165 (MAH09). Probl\u00e9my s identifik\u00e1ciou vr\u00e1tenej platby a ch\u00fdbaj\u00facou inform\u00e1ciou o jej vr\u00e1ten\u00ed (MAH22).<\/p>\n Nezrozumite\u013enos\u0165 platobn\u00fdch predpisov a r\u00f4znorodos\u0165 \u00fa\u010dtov: T\u00edm zodpovedn\u00fd za \u00fahradu poplatkov nerozumel, \u017ee dokument je platobn\u00fd predpis zo \u0160\u00daKL (bez symbolu \u0160\u00daKL), \u017ee je ur\u010den\u00fd pre ich spolo\u010dnos\u0165, \u017ee splatnos\u0165 sa mus\u00ed dodr\u017ea\u0165 a pre\u010do m\u00e1 \u0160\u00daKL dva \u00fa\u010dty a dva postupy pre \u00fahradu poplatkov (spr\u00e1vne poplatky, poplatky zo sadzobn\u00edka) (MAH15).<\/p>\n Priemern\u00e9 hodnotenie je mierne vy\u0161\u0161ie pre platby zo Slovenska (3.89 vs. 3.62)<\/strong>.<\/p>\n Zatia\u013e \u010do MAH zo Slovenska sa stret\u00e1vaj\u00fa predov\u0161etk\u00fdm s ch\u00fdbaj\u00facim potvrden\u00edm o platbe, zahrani\u010dn\u00ed MAH \u010delia syst\u00e9mov\u00fdm prek\u00e1\u017ekam, ako s\u00fa intern\u00e9 syst\u00e9my vy\u017eaduj\u00face dlh\u0161ie doby na \u00fahradu, neopodstatnen\u00e9 invalid\u00e1cie \u017eiadost\u00ed, probl\u00e9my s\u00a0E2E referenciami, absencia spo\u013eahliv\u00fdch potvrden\u00ed o prijat\u00ed platby a komplikovan\u00e9 procesy vr\u00e1tenia pe\u0148az\u00ed<\/strong> (MAH07, MAH10, MAH22).<\/p>\n Typ slu\u017eby: Klinick\u00e9 sk\u00fa\u0161anie<\/strong><\/p>\n Platbu uhr\u00e1dzate zo: Slovenska<\/strong><\/p>\n Bezprobl\u00e9mov\u00e1 a okam\u017eit\u00e1 platba kartou: Platba firemnou kartou zamestnanca je bezprobl\u00e9mov\u00e1 a okam\u017eit\u00e1, pri\u010dom n\u00e1sledn\u00fd email s potvrden\u00edm platby prich\u00e1dza do p\u00e1r min\u00fat a sl\u00fa\u017ei ako d\u00f4kaz o platbe (MAH05).\u00a0<\/p>\n Efektivita platobn\u00fdch predpisov: \u0160\u00daKL vyd\u00e1va platobn\u00fd predpis na presn\u00fa sumu, \u010do v\u00fdznamne prispieva k efektivite procesu (MAH05).\u00a0<\/p>\n Neefekt\u00edvna \u00fahrada zo zahrani\u010dia: \u201ePlatby za klinick\u00e9 sk\u00fa\u0161ania realizovan\u00e9 spolu s\u00a0ostatn\u00fdmi finan\u010dn\u00fdmi dokumentmi prostredn\u00edctvom zahrani\u010dn\u00fdch platieb…boli \u010dasovo n\u00e1ro\u010dn\u00e9 (be\u017ene viac ako jeden t\u00fd\u017ede\u0148) a vy\u017eadovali opakovan\u00e9 urgencie e-mailom\u201c<\/em> (MAH05)<\/p>\n Probl\u00e9my s funk\u010dnos\u0165ou str\u00e1nky \u201e\u00dahrada poplatku\u201c na webe Slovenskej po\u0161ty: Str\u00e1nku \u201e\u00dahrada poplatku\u201c mus\u00ed platite\u013e obnovi\u0165 nieko\u013ekokr\u00e1t, k\u00fdm funguje spr\u00e1vne a umo\u017en\u00ed uhradi\u0165 platobn\u00fd predpis platobnou kartou (MAH05).<\/p>\n Platbu uhr\u00e1dzate zo: zahrani\u010dia<\/strong><\/p>\n Jednoduch\u00e1 platba platobnou kartou: Uhr\u00e1dzanie platobnou kartou v\u00fdrazne u\u013eah\u010duje platenie a nesp\u00f4sobuje \u017eiadne probl\u00e9my (MAH01).<\/p>\n Bezprobl\u00e9mov\u00e9 platby cez extern\u00e9ho dod\u00e1vate\u013ea: Platba cez eKolok, ak je mana\u017eovan\u00e1 extern\u00fdm dod\u00e1vate\u013eom pre podanie klinick\u00fdch sk\u00fa\u0161an\u00ed cez CTIS, prebieha bez probl\u00e9mov cez Request for Information (RFI) (MAH12).<\/p>\n Nefunk\u010dnos\u0165 eKolku v zahrani\u010d\u00ed a nemo\u017enos\u0165 refund\u00e1cie zo zahrani\u010dia: eKolok je mo\u017en\u00e9 zak\u00fapi\u0165 iba cez mobiln\u00fa alebo webov\u00fa aplik\u00e1ciu, \u010do zo zahrani\u010dia nefunguje (MAH08). Refund\u00e1ciu platby nie je mo\u017en\u00e9 zo zahrani\u010dia po\u017eiada\u0165, preto\u017ee si vy\u017eaduje podate\u013e\u0148u alebo elektronick\u00fa schr\u00e1nku s kvalifikovan\u00fdm elektronick\u00fdm podpisom \u0161tatut\u00e1ra (nie je slovensk\u00fd ob\u010dan s eID), a vr\u00e1tenie pe\u0148az\u00ed Slovenskou po\u0161tou je pre subjekty s\u00eddliace v zahrani\u010d\u00ed nemo\u017en\u00e9 (MAH08).<\/p>\n Riziko pre splatnos\u0165 pri platbe vopred: Platba vopred by mohla ohrozi\u0165 splatnos\u0165 eKolku z d\u00f4vodu pos\u00favaj\u00facich sa \u010dasov\u00fdch pl\u00e1nov na podanie klinick\u00fdch sk\u00fa\u0161an\u00ed (MAH12).<\/p>\n Z odpoved\u00ed sa nedaj\u00fa jasne identifikova\u0165 rozdiely pre platby zo Slovenska alebo zahrani\u010dia. Vypl\u00fdva z nich, \u017ee MAH, ktor\u00ed platia platobnou kartou alebo cez tretiu stranu, nemaj\u00fa probl\u00e9my okrem technick\u00fdch probl\u00e9mov so samotnou str\u00e1nkou \u201e\u00dahrada poplatku\u201c (MAH05). MAH v zahrani\u010d\u00ed, ktor\u00fd by aj chcel plati\u0165 kartou, uv\u00e1dza, \u017ee eKolok je nepr\u00edstupn\u00fd; a\u00a0najm\u00e4 procesy refund\u00e1cie platby s\u00fa pre nich zo zahrani\u010dia \u201enemo\u017en\u00e9\u201c<\/strong> (MAH08).<\/p>\n Pod\u013ea Metodick\u00e9ho pokynu \u0160\u00daKL (MP 149\/2025) sa spr\u00e1vne poplatky platia za \u00fakony a konania uveden\u00e9 v sadzobn\u00edku. Poplatkov\u00e1 povinnos\u0165 vznik\u00e1 pri podan\u00ed, ktor\u00e9 smeruje k vykonaniu \u00fakonu. v pr\u00edpade neuhradenia poplatku, ani po p\u00edsomnej v\u00fdzve, \u0160\u00daKL \u00fakon nevykon\u00e1 a konanie zastav\u00ed.<\/p>\n Potvrdenie o \u00fahrade spr\u00e1vneho\/s\u00fadneho poplatku (eKolok) si poplatn\u00edk m\u00f4\u017ee zak\u00fapi\u0165 bu\u010f v po\u017eadovanej hodnote bez uvedenej slu\u017eby, alebo na konkr\u00e9tny \u00fakon pod\u013ea katal\u00f3gu slu\u017eieb \u0160\u00daKL na vybran\u00fdch pobo\u010dk\u00e1ch Slovenskej po\u0161ty.<\/p>\n K\u013e\u00fa\u010dov\u00e9 inform\u00e1cie o platobn\u00fdch met\u00f3dach:<\/strong><\/p>\n Zak\u00fapenie eKolku<\/p>\n \u00dahrada na z\u00e1klade platobn\u00e9ho predpisu vystaven\u00e9ho \u0160\u00daKL:<\/p>\n Postup \u0160\u00daKL pri nespr\u00e1vnom eKolku: \u0160\u00daKL neakceptuje eKolok zak\u00fapen\u00fd pre in\u00fd spr\u00e1vny org\u00e1n alebo pre in\u00fd \u00fakon v r\u00e1mci \u0160\u00daKL, ak sa ID slu\u017eby nezhoduje. v takom pr\u00edpade \u0160\u00daKL vr\u00e1ti eKolok poplatn\u00edkovi, ktor\u00fd sa mus\u00ed obr\u00e1ti\u0165 na Slovensk\u00fa po\u0161tu oh\u013eadom storna.<\/p>\n Vr\u00e1tenie spr\u00e1vnych poplatkov alebo preplatkov: Realizuje Slovensk\u00e1 po\u0161ta na z\u00e1klade pr\u00e1voplatn\u00e9ho rozhodnutia \u0160\u00daKL. Poplatn\u00edk \u017eiada o vr\u00e1tenie prostredn\u00edctvom tla\u010diva na webovej str\u00e1nke \u0160\u00daKL.<\/p>\n Zavedenie syst\u00e9mu eKolok pre niektor\u00fdch MAH skomplikovalo a spomalilo platby spr\u00e1vnych poplatkov. Hoci niektor\u00ed oce\u0148uj\u00fa z\u00e1kladn\u00fa jednoduchos\u0165 a r\u00fdchlos\u0165, existuje zna\u010dn\u00fd priestor na zlep\u0161enie<\/strong>, najm\u00e4 v oblasti transparentnosti, komunik\u00e1cie a prisp\u00f4sobenia sa potreb\u00e1m zahrani\u010dn\u00fdch platcov. SARAP ver\u00ed, \u017ee na z\u00e1klade t\u00fdchto zisten\u00ed bude mo\u017en\u00e9 vies\u0165 kon\u0161trukt\u00edvny dial\u00f3g so Slovenskou po\u0161tou a \u0160\u00daKL<\/strong> s cie\u013eom dosiahnu\u0165 v\u00fdrazn\u00e9 zlep\u0161enie efekt\u00edvnosti procesu a pred\u00eds\u0165 invalid\u00e1cii registra\u010dn\u00fdch procesov s negat\u00edvnym dopadom na ostatn\u00e9 \u010dlensk\u00e9 \u0161t\u00e1ty E\u00da.<\/p>\n [1]<\/a> CMDh_292_2013_Rev23_2025_10_clean_-_Chapter_2_-_Procedure_for_the_Automatic_Validation_of_MRP_for_Variations.pdf<\/a><\/p>\n [2]<\/a> Regulation – 536\/2014 – EN – EUR-Lex<\/a><\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" Tento dokument sumarizuje sk\u00fasenosti a\u202fk\u013e\u00fa\u010dov\u00e9 zistenia vypl\u00fdvaj\u00face z\u202fmetodick\u00e9ho pokynu \u0160t\u00e1tneho \u00fastavu pre kontrolu lie\u010div (\u0160\u00daKL) k syst\u00e9mu eKolok a\u202fz\u202fdotazn\u00edka Slovenskej asoci\u00e1cie spolo\u010dnost\u00ed v oblasti liekovej regul\u00e1cie (SARAP) zameran\u00e9ho na sk\u00fasenosti s t\u00fdmto platobn\u00fdm port\u00e1lom. Cie\u013eom SARAP je na z\u00e1klade t\u00fdchto zisten\u00ed vies\u0165 \u010fal\u0161iu diskusiu so \u0160\u00daKL a Slovenskou po\u0161tou za \u00fa\u010delom zlep\u0161enia a\u202fzjednodu\u0161enia platieb. V tomto dokumente sa pojmom eKolok mysl\u00ed platba cez elektronick\u00fd kolok aj prostredn\u00edctvom platobn\u00e9ho predpisu. 1. Kontext \u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div (\u0160\u00daKL) je od 1. septembra 2024 zapojen\u00fd do Centr\u00e1lneho syst\u00e9mu evidencie poplatkov (CSEP), ktor\u00fd prev\u00e1dzkuje Slovensk\u00e1 po\u0161ta, a.s. Tento syst\u00e9m umo\u017e\u0148uje \u00fahradu spr\u00e1vnych poplatkov za \u00fakony a konania \u0160\u00daKL prostredn\u00edctvom slu\u017eby \u201eeKolok\u201c. Na module SARAP (2. j\u00fana 2026) bola diskutovan\u00e1 t\u00e9ma platieb cez eKolok, pri\u010dom viacer\u00ed \u010dlenovia vyjadrili nespokojnos\u0165 a obavy, \u017ee platby prostredn\u00edctvom Slovenskej po\u0161ty m\u00f4\u017eu naru\u0161i\u0165 valid\u00e1ciu podanej zmeny alebo schv\u00e1lenia klinickej \u0161t\u00fadie. v reakcii na to SARAP vytvoril dotazn\u00edk s otvorenou ot\u00e1zkou (\u201ePop\u00ed\u0161te va\u0161u sk\u00fasenos\u0165\u201c) a\u00a0mo\u017enos\u0165ou hodnotenia funk\u010dnosti syst\u00e9mu eKolok na stupnici 1-5, pri\u010dom 5 bolo najlep\u0161ie. V\u00fdstupy dotazn\u00edka s\u00fa pou\u017eit\u00e9 na vytvorenie tohto dokumentu a\u00a0bud\u00facu diskusiu so \u0160\u00daKL a Slovenskou po\u0161tou za \u00fa\u010delom zlep\u0161enia a zjednodu\u0161enia platieb. 2. K\u013e\u00fa\u010dov\u00e9 zistenia z prieskumu SARAP Asoci\u00e1cia SARAP dostala 29 odpoved\u00ed od 24 \u010dlenov – dr\u017eite\u013eov registr\u00e1cie liekov (\u010falej len MAH) alebo ich z\u00e1stupcov v priebehu j\u00fana a j\u00fala 2026. Prieskum odhalil zmie\u0161an\u00e9 sk\u00fasenosti s platobn\u00fdm port\u00e1lom. Priemern\u00e9 hodnotenie funk\u010dnosti bolo pribli\u017ene 3,6 z\u00a05,0. Celkovo mo\u017eno kon\u0161tatova\u0165 nasledovn\u00e9:\u00a0 MAH platiaci zo Slovenska maj\u00fa spravidla plynulej\u0161ie a pozit\u00edvnej\u0161ie sk\u00fasenosti s platbami, hoci im ch\u00fdba potvrdenie o prijat\u00ed platby.\u00a0 MAH platiaci zo zahrani\u010dia sa stret\u00e1vaj\u00fa s v\u00fdraznej\u0161\u00edmi probl\u00e9mami. Tie vypl\u00fdvaj\u00fa najm\u00e4 z nedostato\u010dn\u00e9ho \u010dasu na \u00fahradu platby. K\u00fdm v predch\u00e1dzaj\u00facom sp\u00f4sobe platby sa v\u00fdpo\u010det poplatku vykonal v internom syst\u00e9me \u0160\u00daKL eVar a dal sa spo\u013eahlivo hradi\u0165 prevodom aj nieko\u013eko t\u00fd\u017ed\u0148ov pred podan\u00edm \u017eiadosti o zmenu alebo klinick\u00e9 sk\u00fa\u0161anie, platobn\u00fd predpis v syst\u00e9me eKolok dostane MAH a\u017e de\u0148-dva po podan\u00ed \u017eiadosti o zmenu a na \u00fahradu m\u00e1 len obmedzen\u00fd \u010das zodpovedaj\u00faci \u010dasu na valid\u00e1ciu podania (pri ur\u010dit\u00fdch zmen\u00e1ch len 14 dn\u00ed[1], v\u00a0praxi max. 10 dn\u00ed). V\u00a0pr\u00edpade klinick\u00fdch sk\u00fa\u0161an\u00ed dostane MAH platobn\u00fd predpis a\u017e v\u00a0\u010dase vydania Request for Information (RFI) a\u00a0na \u00fahradu m\u00e1 menej ako 12 dn\u00ed[2]. V kombin\u00e1cii s intern\u00fdmi nastaveniami MAH \u2013 kde sa ak\u00e1ko\u013evek platba hrad\u00ed bankov\u00fdm prevodom a nie je mo\u017en\u00e9 ju okam\u017eite uhradi\u0165 platobnou kartou, dlh\u00fdmi intern\u00fdmi administrat\u00edvnymi procesmi spracovania platby, s\u00a0pevne ur\u010den\u00fdmi rozvrhmi platobn\u00fdch kalend\u00e1rov, sa m\u00f4\u017ee sta\u0165, \u017ee sa platba nestihne uhradi\u0165 v\u010das a\u00a0Slovensko zabrzd\u00ed valid\u00e1ciu \u017eiadosti o\u00a0zmenu alebo klinick\u00e9 sk\u00fa\u0161anie v\u00a0r\u00e1mci E\u00da. eKolok s\u00edce umo\u017e\u0148uje aj \u00fahradu vopred, e\u0161te pred podan\u00edm \u017eiadosti (pozri \u010das\u0165 5), av\u0161ak to si vy\u017eaduje, aby MAH presne vypo\u010d\u00edtal poplatok (bez mo\u017enej konzult\u00e1cie so \u0160\u00daKL), zak\u00fapil eKolok na pobo\u010dke po\u0161ty alebo cez webov\u00e9 rozhranie a uhradil ho v hotovosti alebo platobnou kartou. Vopred zak\u00fapen\u00fd eKolok nie je mo\u017en\u00e9 uhradi\u0165 prevodom. Iba minimum MAH m\u00e1 mo\u017enos\u0165 hradi\u0165 platby inak ako prevodom. Platnos\u0165 eKolku zak\u00fapen\u00e9ho prostredn\u00edctvom internetu je obmedzen\u00e1 na 30 dn\u00ed. v pr\u00edpade posunu term\u00ednov podan\u00ed zo strany MAH tak vznik\u00e1 riziko, \u017ee jeho platnos\u0165 uplynie e\u0161te pred podan\u00edm \u017eiadosti. \u010eal\u0161\u00edm probl\u00e9mom je situ\u00e1cia, ke\u010f poplatok vypo\u010d\u00edtan\u00fd \u0160\u00daKL nezodpoved\u00e1 hodnote eKolku alebo zvolenej slu\u017ebe, pr\u00edpadne ak sa na posledn\u00fa chv\u00ed\u013eu zmen\u00ed po\u010det alebo typ zmien. v takom pr\u00edpade mus\u00ed MAH eKolok vr\u00e1ti\u0165 a zak\u00fapi\u0165 nov\u00fd, pr\u00edpadne \u010daka\u0165 na vystavenie platobn\u00e9ho predpisu, \u010do cel\u00fd proces administrat\u00edvne predl\u017euje. V\u0161eobecn\u00fdm zisten\u00edm prieskumu je:\u00a0 Preferovanie platobn\u00fdch predpisov pred n\u00e1kupom eKolkov: V\u00e4\u010d\u0161ina spolo\u010dnost\u00ed uprednost\u0148uje platobn\u00fd predpis od \u0160\u00daKL pred priamym n\u00e1kupom eKolkov. Pozit\u00edvne zistenia:\u00a0 Jednoduchos\u0165 a r\u00fdchlos\u0165 platby: Niektor\u00ed respondenti hodnotili zadanie platby ako jednoduch\u00e9 a r\u00fdchle, ak sa realizuje prostredn\u00edctvom firemnej karty alebo priamo cez webov\u00fa\/mobiln\u00fa aplik\u00e1ciu. Dostato\u010dn\u00e1 doba splatnosti: Doba splatnosti 30 dn\u00ed je pre niektor\u00fdch vyhovuj\u00faca, pokia\u013e maj\u00fa intern\u00e9 procesy nastaven\u00e9 na zr\u00fdchlen\u00e9 platby. Doba splatnosti 20 dn\u00ed (zmeny typu IA) je u\u017e \u201enatesno\u201c. P\u00e1rovanie platieb: Niektor\u00e9 spolo\u010dnosti nezaznamenali probl\u00e9my so sp\u00e1rovan\u00edm platieb. Flexibilita \u0160\u00daKL: Oce\u0148ovan\u00e1 je spolupr\u00e1ca so \u0160\u00daKL a ich flexibilita pri komunik\u00e1cii. V\u00fdzvy a negat\u00edvne sk\u00fasenosti:\u00a0 Nejasnosti v platobn\u00fdch predpisoch: Platobn\u00e9 predpisy zo \u0160\u00daKL neobsahuj\u00fa jasn\u00e9 identifik\u00e1tory (logo \u0160\u00daKL, n\u00e1zov spolo\u010dnosti), \u010do sp\u00f4sobuje intern\u00e9 probl\u00e9my s identifik\u00e1ciou a spracovan\u00edm v \u00fa\u010dtovn\u00fdch t\u00edmoch. Takisto je pre niektor\u00fdch dr\u017eite\u013eov probl\u00e9m uv\u00e1dzanie referencie, pomocou ktorej sa d\u00e1 platba identifikova\u0165. Rizik\u00e1 v\u010dasnej \u00fahrady: Napriek 30-d\u0148ovej splatnosti s\u00fa platby \u010dasto \u201enatesno\u201c (\u010das na valid\u00e1ciu podanej \u017eiadosti je krat\u0161\u00ed) kv\u00f4li intern\u00fdm schva\u013eovac\u00edm procesom alebo rozvrhmi platieb, \u010do m\u00f4\u017ee vies\u0165 k oneskoreniam a vr\u00e1teniu platby Slovenskou po\u0161tou, o \u010dom platca niekedy nevie. Invalid\u00e1cia \u017eiadost\u00ed: Napriek 30-d\u0148ovej splatnosti sa \u017eiados\u0165 jav\u00ed invalidovan\u00e1 hne\u010f na druh\u00fd de\u0148 po podan\u00ed. Ch\u00fdbaj\u00face potvrdenie o prijat\u00ed platby: Viacer\u00fdm spolo\u010dnostiam ch\u00fdba notifik\u00e1cia od \u0160\u00daKL o prijat\u00ed a sp\u00e1rovan\u00ed platby, \u010do by zv\u00fd\u0161ilo istotu a preh\u013ead na strane MAH. Probl\u00e9my s procesom vr\u00e1tenia platby: Proces vr\u00e1tenia platby Slovenskou po\u0161tou je vn\u00edman\u00fd ako zd\u013ahav\u00fd a nepreh\u013eadn\u00fd. Navy\u0161e, Slovensk\u00e1 po\u0161ta pri vr\u00e1ten\u00ed neuv\u00e1dza d\u00f4le\u017eit\u00e9 detaily (napr. variabiln\u00fd symbol), \u010do s\u0165a\u017euje sp\u00e1rovanie vr\u00e1ten\u00fdch s\u00fam. 3. Navrhovan\u00e9 odpor\u00fa\u010dania na zlep\u0161enie Na z\u00e1klade z\u00edskan\u00fdch d\u00e1t a sp\u00e4tnej v\u00e4zby od \u010dlenov SARAP je mo\u017en\u00e9 identifikova\u0165 nieko\u013eko k\u013e\u00fa\u010dov\u00fdch oblast\u00ed pre zlep\u0161enie fungovania syst\u00e9mu eKolok a s\u00favisiacich procesov \u0160\u00daKL a Slovenskej po\u0161ty:\u00a0 Umo\u017eni\u0165, aby vopred zak\u00fapen\u00fd eKolok nebol striktne viazan\u00fd na presne definovan\u00fa slu\u017ebu, mal dlh\u0161iu platnos\u0165 ako 30 dn\u00ed pri zak\u00fapen\u00ed cez internet a jeho \u00fahrada bola mo\u017en\u00e1 bankov\u00fdm prevodom. Zrozumite\u013enos\u0165 platobn\u00fdch predpisov: \u0160tandardizova\u0165 formu platobn\u00fdch predpisov vystavovan\u00fdch \u0160\u00daKL tak, aby obsahovali jasn\u00e9 identifika\u010dn\u00e9 prvky (logo \u0160\u00daKL, n\u00e1zov \u017eiadate\u013ea). Zlep\u0161enie komunik\u00e1cie o stave platby:zavies\u0165 automatick\u00e9 e-mailov\u00e9 notifik\u00e1cie o\u00a0prijat\u00ed a sp\u00e1rovan\u00ed platby zo strany \u0160\u00daKL. Harmoniz\u00e1cia lehoty splatnosti a valid\u00e1cie: Prehodnoti\u0165 prax okam\u017eitej invalid\u00e1cie \u017eiadost\u00ed, ke\u010f je e\u0161te v platnosti 30-d\u0148ov\u00e1 lehota na \u00fahradu. Zabezpe\u010di\u0165, aby bol proces valid\u00e1cie v s\u00falade s ofici\u00e1lne deklarovan\u00fdmi lehotami splatnosti. Zjednodu\u0161enie procesu vr\u00e1tenia platieb: \u0161tandardizova\u0165 a zr\u00fdchli\u0165 proces vr\u00e1tenia platieb zo strany Slovenskej po\u0161ty, najm\u00e4 pre zahrani\u010dn\u00e9 subjekty. Poskytova\u0165 jasn\u00e9 inform\u00e1cie o vr\u00e1ten\u00fdch platb\u00e1ch vr\u00e1tane d\u00f4vodu a identifik\u00e1torov (napr. variabiln\u00fd symbol).\u00a0 4. Podrobn\u00e1 anal\u00fdza odpoved\u00ed Pri odpovediach sa rozli\u0161ovali typ slu\u017eby a odkia\u013e sa za \u0148u plat\u00ed. Typ slu\u017eby:\u00a0 Registr\u00e1cia\/Pred\u013a\u017eenie registr\u00e1cie\/Prevod registr\u00e1cie\/Ozn\u00e1menia a\u00a0zmeny v\u00a0registr\u00e1cii lieku Klinick\u00e9 \u0161t\u00fadie In\u00e9 (respondenti uviedli \u201eFarmakovigilancia\u201c a \u201erefund\u00e1cia spr\u00e1vneho poplatku\u201c) \u00dahrada platby zo:\u00a0 Slovenska zahrani\u010dia Typ slu\u017eby: Registr\u00e1cia\/Pred\u013a\u017eenie registr\u00e1cie\/Prevod registr\u00e1cie\/Ozn\u00e1menia a zmeny v registr\u00e1cii lieku Platbu uhr\u00e1dzate zo: Slovenska\u00a0 Priemern\u00e9 hodnotenie funk\u010dnosti: 3,89 z\u00a05,00 Pozit\u00edvne sk\u00fasenosti: Jednoduchos\u0165 a bezprobl\u00e9movos\u0165 \u00fahrady: \u201eV\u0161etko funguje ako m\u00e1, nezaznamenali sme \u017eiadne probl\u00e9my s \u00fahradou.\u201c (MAH04). \u201eProces platby nie je zlo\u017eit\u00fd a\u00a0platobn\u00fd predpis sa \u00fa\u010dtuje ako in\u00e9 fakt\u00fary\u201c (MAH03). Dostato\u010dn\u00e1 doba splatnosti a bezprobl\u00e9mov\u00e9 p\u00e1rovanie: Doba splatnosti 30 dn\u00ed je dostato\u010dn\u00e1 a nie s\u00fa probl\u00e9my so sp\u00e1rovan\u00edm platby (MAH05, MAH03).<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"iawp_total_views":128,"footnotes":""},"categories":[56],"tags":[187,188,192,190,189],"class_list":["post-10700","post","type-post","status-publish","format-standard","hentry","category-aktuality","tag-ekolok","tag-platobna-predpis","tag-sarap","tag-sukl","tag-uhrada-spravneho-poplatku"],"_links":{"self":[{"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/posts\/10700","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/comments?post=10700"}],"version-history":[{"count":54,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/posts\/10700\/revisions"}],"predecessor-version":[{"id":10755,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/posts\/10700\/revisions\/10755"}],"wp:attachment":[{"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/media?parent=10700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/categories?post=10700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sarap.sk\/sk\/wp-json\/wp\/v2\/tags?post=10700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}2. K\u013e\u00fa\u010dov\u00e9 zistenia z prieskumu SARAP<\/u><\/strong><\/h6>\n
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3. Navrhovan\u00e9 odpor\u00fa\u010dania na zlep\u0161enie<\/u><\/strong><\/h6>\n
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4. Podrobn\u00e1 anal\u00fdza odpoved\u00ed<\/u><\/strong><\/h6>\n
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5. Metodika \u00fahrady spr\u00e1vnych poplatkov \u0160\u00daKL cez eKolok<\/u><\/strong><\/h6>\n
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6. Z\u00e1ver<\/u><\/strong><\/h6>\n
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