413
Ravimiseaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus
Introduced
14 June 2021
Last action
15 December 2021 · Accepted
Status
AVALDATUD_RIIGITEATAJAS
Sponsors
Siret Kotka, Vabariigi Valitsus
Subjects
Discovery layer
Source updated
15 December 2021
Summary
Eelnõuga viiakse ravimiseadus kooskõlla Euroopa Liidu õigusaktidega, millega nähakse ette reeglid tervishoius kasutatavate ravimite kliiniliste uuringute, veterinaarravimite kliiniliste uuringute ning haiglaerandi ravimi kohta. Eelnõu näeb ette võimaluse valmistada ja kasutada haiglas erandkorras uudseid ravimeid. Kehtestatakse nõuded, et tagada ravimite kvaliteet, ohutus ning ravi jälgimine. Selliseid uudseid ravimeid saab valmistada ja kasutada üksnes Eestis eriarsti individuaalse tellimuse alusel ja tema kutsealasel vastutusel konkreetse patsiendi raviks haiglas. Tegemist on ELis uudseteks ravimiteks nimetatud ravimitega, mis jagatakse geeniteraapia, somaatilise rakuteraapia ja koetehnoloogia ravimiteks ning mis pakuvad patsientidele uusi ravimeetodeid teatud liiki haiguste ja väärtalitluste raviks. Haiglaerandi ravimi kasutamisest saadud andmete põhjal on hiljem võimalik alustada ravimiga kliinilisi uuringuid ning seejärel jõuda ka müügiloa taotlemiseni. Haiglaerandi regulatsioon lubab planeerida konkreetseid arengusuundi ja koostöövõimalusi Eesti ülikoolide, biotehnoloogia ettevõtete ja haiglate vahel. Eelnõuga lihtsustatakse kliiniliste uuringutele loa taotlemise protsessi, eeskätt siis, kui taotleja soovib uuringut läbi viia paljudes ELi liikmesriikides. Sel juhul suhtleb taotleja kogu protsessi vältel ühe liikmesriigi ravimiametiga, kes kogu protsessi ja infovahetust taotleja ning teiste liikmesriikide vahel ELis koordineerib ning kes koostab ka uuringutaotluse teadusliku hindamisearuande. Kliinilise uuringu loa taotlemine toimub edaspidi ühe taotluse alusel kõikides soovitud liikmesriikides ühtse loa taotlemise toimiku abil kliiniliste uuringute portaali vahendusel ja paberivabalt. Samuti tasub sponsor edaspidi kliinilise uuringu taotlemisel ühes liikmesriigis ühekordse tasu. Praegu tasub sponsor Eestis kolm erinevat tasu: tasu ravimiametile, eetikakomiteele ja riigilõivu. Kliinilise uuringu taotlust hindavad liikmesriigid ühiselt ning koostatakse üks ühine lõppotsus. Kliinilise uuringu lõpptulemused on ühises andmebaasis ja avalikud ning seetõttu saab rohkem teavet avalikuks. Avalikuks saab uuringu hinnangu kokkuvõte, uuringu- ja inspektsiooni tulemused. Kehtestatakse ka nõuded nende ravimite kvaliteedi ja ohutuse tagamiseks, mida uuringus osalejatele kliinilise uuringu käigus manustatakse. Erilist tähelepanu pööratakse patsiendiõiguste ja -ohutuse kõrgetasemelise kaitsele. Seadus oli kavandatud jõustuma kuue kuu möödumisel ajast, millal Euroopa Komisjon avaldab Euroopa Liidu Teatajas teate selle kohta, et EL-i kliiniliste uuringute portaal ja EL-i andmebaas on saavutanud täieliku toimivuse, eeldatavalt juhtub see juulis 2021. Veterinaarravimite kliiniliste uuringute osas on seaduse muudatused plaanitud jõustuma 2022. aasta 28. jaanuaril ning haiglaerandi regulatsiooni puudutavad sätted jõustuvad üldises korras.
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Timeline
14 June 2021
AVALDATUD_RIIGITEATAJAS
Source: SE
15 December 2021
Accepted
Votes
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Documents
26 official files
Lõpptekst
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Lõpptekst
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Eelnõu
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Sponsors
- Siret Kotka · plenary-member
- Vabariigi Valitsus · Vabariigi Valitsus · Initiator
Related records
No cross-record relationships stored yet.
Related across the Repo ecosystem
Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.
Direct relationships
- Legal framework · Ravimiseaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus · 413 · EE
- Identifier matchPROJECTS_FROM
Same estonia record 2c65d2f4-8180-4788-9ae3-0eb27e26628c projected from PoliticalRepo EE row.
Ravimiseaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.riigikogu.ee/tegevus/eelnoud/2c65d2f4-8180-4788-9ae3-0eb27e26628c/
- Open data entity: https://api.riigikogu.ee/api/volumes/2c65d2f4-8180-4788-9ae3-0eb27e26628c
- estonia · 2c65d2f4-8180-4788-9ae3-0eb27e26628c · source updated 15 December 2021