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Estonia · Law · SE

299

Ravimiseaduse, ravikindlustuse seaduse ja tervishoiuteenuste korraldamise seaduse muutmise seadus

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

27 September 2023

Last action

23 November 2023 · Accepted

Status

AVALDATUD_RIIGITEATAJAS

Sponsors

Irja Lutsar, Vabariigi Valitsus

Subjects

Discovery layer

Source updated

23 November 2023

Summary

Eelnõu ajakohastab ravimiseadust ja viib selle kooskõlla ELi õigusega, samuti vähendab ebavajalikku halduskoormust ravimituru osapooltele. Eelnõus ette nähtud muudatused parandada ravimite kättesaadavust ning arendada apteegiteenuseid. Eelnõu kohaselt võimaldatakse edaspidi tarbijatel ravimijäätmeid apteekidesse tagastada lihtsustatud korras. Praegu tuleb ravimite tagastamisel koostada üleandmise-vastuvõtmise akt, millest nähtuvad üleandja nimi, ravimpreparaadi nimetus ja kogus ning akt tuleb osapoooltel allkirjastada. Samuti antakse apteekidele võimalus viia läbi ravimitega reisimise nõustamist ning väljastada ravimitega reisimiseks vajalikke Schengeni tunnistusi. Praegu teeb seda Ravimiamet. Lisaks võimaldatakse apteegil arsti retsepti alusel valmistatud või jaendatud ravimeid väljastada ka teistele apteekidele võimaldades seeläbi patsientidel saada selliseid ravimeid kätte neile sobivast apteegist. Kehtiva korra täiendamisega kaasneb ravimite hulgimüügi või tootmise tegevusloaga automaatselt eriluba nõudva kauba sisse- ja väljaveo õigus ning enam pole vaja sätestada lubadel eritingimusi. Samuti täpsustatakse eelnõus, kes on ravimite sisse- ja väljavedaja, asendatakse ravimite ekspordiloa taotlemine ja müügiloata ravimite Euroopa Majanduspiirkonna liikmesriigist sisseveo taotlemine teavitusmenetlusega, vähendades nii halduskoormust. Kaotatakse võimalus ravimi tootmise tegevusloa omajal teostada lisaks tootmistegevusele ka hulgimüüki ilma hulgimüügi tegevusluba omamata. Ajakohastatakse ka ravimireklaami nõudeid. Edaspidi on võimalik lisaks müügiloa hoidjale ravimireklaami nõuete rikkumise eest vastutusele võtta ka reklaami tellija, avalikustaja ja teostaja, kes rikkumise toime paneb. Eelnõuga reguleeritakse täpsemalt võimalust tagada Eesti patsientidele juurdepääs uutele väljatöötatavatele ravimitele olukorras, kus puuduvad muud võimalused kroonilise või eluohtliku haiguse raviks ning innovaatiliste ravimite ja meetodite kättesaadavus on jäänud patsiendile ainsaks võimalikuks lahenduseks. Samuti antakse ravimite järjepideva kättesaadavuse tagamiseks Ravimiametile õigus erandlikel juhtudel (näiteks tarneraskuste korral) ajutiselt piirata ravimite apteegist väljastatavaid koguseid või lubada väljastamist vaid teatud diagnooside puhul.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 27 September 2023

    AVALDATUD_RIIGITEATAJAS

    Source: SE

  2. 23 November 2023

    Accepted

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Documents

31 official files

Lõpptekst

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