Návrh zmeny zákona o liekoch a zdravotníckych pomôckach | Medicínske právo
              

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Návrh zmeny zákona o liekoch a zdravotníckych pomôckach


 | 2.7.2014 | komentárov: 311

Národnej rade SR bol predstavený poslanecký návrh novely zákona č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov.

Obrazok

Cieľom tohto návrhu je, podľa dôvodovej správy, zabránenie vzniku situácie, kedy by lekárne mali nedostatok liekov kvôli ich predaju do zahraničia. Zároveň sa predpokladá zvýšenie zásob liekov v slovenských lekárňach.

Držitelia povolenia na veľkodistribúciu liekov majú mať podľa predloženého návrhu povinnosť odoberať lieky len od zákonom ustanovených subjektov, ktorými sú:
•    iný držiteľ povolenia na veľkodistribúciu liekov
•    výrobca, ktorý lieky vyrába alebo dováža
•    lekáreň, vracajúca držiteľovi povolenia na veľkodistribúciu liekov lieky, ktoré jej dodal.

Osoby, ktoré sú oprávnené vydávať humánne lieky alebo sprostredkovať ich nákup a predaj, budú povinné viesť dokumentáciu pri každej dodávke lieku, umožňujúcej sledovanie cesty  jeho distribúcie.

Prevádzkovateľovi lekárne, ktorý je zároveň držiteľom povolenia na veľkodistribúciu vznikne podľa návrhu novely, povinnosť oznamovať  pri nákupe lieku jeho distribútorovi či v danom vzťahu vystupuje ako prevádzkovateľ lekárne alebo distribútor. Okrem toho bude mať takáto lekáreň zakázané sprostredkovanie humánnych liekov, ktoré kúpila ako lekáreň.

Návrh novely je momentálne predložený na prerokovanie výborom NR SR.
   

Spracovala: Ľudmila Moľová

Zdroj: http://www.nrsr.sk/web/Default.aspx?sid=zakony/zakon&ZakZborID=13&CisObdobia=6&CPT=1069
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