Zabezpečenie označenia vonkajšieho obalu lieku písmom pre nevidiacich (Braillovo písmo) | Medicínske právo
              

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Zabezpečenie označenia vonkajšieho obalu lieku písmom pre nevidiacich (Braillovo písmo)


 | 29.5.2011 | komentárov: 478

S účinnosťou od 1. júna 2011 má držiteľ rozhodnutia o registrácii lieku zabezpečiť, aby bol vonkajší obal lieku označený písmom pre nevidiacich (Braillovo písmo) v súlade s § 24 ods. 9. zákona č. 140/1998 Z. z. o liekoch a zdravotníckych pomôckach v znení neskorších predpisov.

Obrazok

Štátny ústav pre kontrolu liečiv sa stotožňuje s vyjadrením MZ SR adresovaným Asociácii dodávateľov liekov a zdravotníckych pomôcok a to konkrétne k preznačovaniu obalov humánnych liekov transparentnou trojrozmernou nálepkou obsahujúcou názov lieku v Braillovom písme. 

Uvedené preznačenie vonkajšieho obalu nálepkou sa bude vykonávať iba v podmienkach správnej výrobnej praxe u výrobcov, ktorí na takúto činnosť majú povolenie. V prípade akéhokoľvek opodstatneného podozrenia na nekvalitu transparentných nálepiek, bude  každá dotknutá farmaceutická spoločnosť povinná  bezodkladne stiahnuť dotknuté šarže lieku z trhu.

VYJADRENIE MINISTERSTVA ZDRAVOTNÍCTVA SLOVENSKEJ REPUBLIKY
k povinnosti držiteľa rozhodnutia o registrácii lieku označiť názov lieku na vonkajšom obale liekov, ktoré boli registrované na základe žiadosti o registráciu lieku podanej do 1.júna 2006, písmom pre nevidiacich (Braillovo písmo)

Podľa platnej právnej úpravy zákona č. 140/1998 Z. z. o liekoch a zdravotníckych pomôckach (ďalej len „zákon“) je držiteľ rozhodnutia o registrácii lieku (výrobca liekov alebo ním splnomocnený zástupca) povinný zabezpečiť, aby od 1. júna 2011 na vonkajšom obale lieku bol názov lieku v rozsahu údajov podľa § 24 ods. 1 písm. a) vyjadrený aj písmom pre nevidiacich (Braillovo písmo); ak vonkajší obal lieku je označený okrem štátneho jazyka aj v iných jazykoch, názov lieku musí byť vyjadrený písmom pre nevidiacich (Braillovo písmo) vo všetkých jazykoch uvedených na vonkajšom obale. Ak liek má registrovanú len jednu silu lieku, sila lieku sa nemusí na vonkajšom obale vyznačiť písmom pre nevidiacich.

Na základe tohto ustanovenia nemôže po 1. júni 2011 držiteľ rozhodnutia o registrácii lieku dodávať subjektom v súlade so zákonom lieky bez toho, aby bol na vonkajšom obale lieku názov lieku vyjadrený písmom pre nevidiacich.

Platná právna úprava účinná od 1. júna 2006 ustanovila prechodné obdobie v trvaní 5 rokov na zabezpečenie tejto povinnosti držiteľom rozhodnutia o registrácii lieku pre nevidiacich pacientov. Táto lehota uplynie 31. mája 2011 a niektorí držitelia rozhodnutia o registrácii lieku aj napriek tejto dostatočne dlhej dobe nemajú pripravené vonkajšie obaly označené Braillovým písmom. Aby sa zachovala dostupnosť liekov pre slovenských pacientov, je možné vonkajšie obaly dodávané držiteľom povolenia na veľkodistribúciu liekov (veľkodistribútor) prelepiť tak, aby obsahovali názov lieku označený Braillovým písmom. Na prelepenie vonkajšieho obalu je možné použiť transparentné nálepky s trojrozmerným označením názvu lieku v Braillovom písme. Takého preznačovanie musí byť vykonané v súlade a v podmienkach správnej výrobnej praxe u subjektov, ktoré na takúto činnosť majú povolenie a len na lieky, ktoré boli vyrobené do 31. mája 2011.

Lieky vyrobené po tomto termíne už musia mať na vonkajšom obale lieku názov lieku vyjadrený písmom pre nevidiacich v súlade s týmto zákonom.

Zásoby liekov, ktoré boli dodané držiteľom povolenia na veľkodistribúciu liekov alebo držiteľom povolenia na poskytovanie lekárenskej starostlivosti (lekárne) do 31. mája 2011, a ktoré nie sú označené Braillovým písmom, je možné dopredať.

Zdroj: ŠÚKL , pôvodne tu
Foto: stockphotos.sk


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