278
Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seaduse ning riigilõivuseaduse muutmise seadus
Introduced
12 September 2016
Last action
22 February 2017 · Accepted
Status
AVALDATUD_RIIGITEATAJAS
Sponsors
Viktor Vassiljev, Vabariigi Valitsus
Subjects
Discovery layer
Source updated
22 February 2017
Summary
Eelnõuga võetakse Eesti õigusesse üle kaks Euroopa Komisjoni direktiivi, et tagada kolmandatest riikidest imporditud rakkude ja kudede vastavus ELi ohutus- ja kvaliteedistandarditele. Eelnõuga täpsustatakse, et uudse ravimi tootmiseks kasutatavate rakkude ja kudedega seotud teave peab olema jälgitav vähemalt seni, kuni see jõuab ravimi tootjani. Pärast direktiivide rakendumist, peab Ravimiamet registreerima Euroopa Liidu koepangaregistris kõik ettevõtted, kes tegelevad rakkude ja kudede hankimise ning käitlemisega ja kellele on antud vastav tegevusluba, seal hulgas impordisertifikaat. Rakkude ja kudede käitlemisega tegeleb Eestis praegu üheksa ettevõtjat, kellest kaks tegeleb rakkude ja kudede impordiga kolmandatest riikidest. Käesoleva seaduse jõustumisel tuleb neil kahel ettevõtjal taotleda vastav impordisertifikaat. Uudse ravimi tootja tegevusluba on välja antud ühele ettevõtjale. Uudne ravim on geeniteraapiaks või somaatilise raku teraapiaks ettenähtud ravim või koetehnoloogiline toode. Alates 29. aprillist 2017 antakse kõikidele hangitud ja käideldud rakkudele ja kudedele ning nendest valmistatud toodetele kordumatu Euroopa kood, mis koosneb annetuse ja toote identifitseerimistunnustest.
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Timeline
12 September 2016
AVALDATUD_RIIGITEATAJAS
Source: SE
22 February 2017
Accepted
Votes
No vote records are attached yet.
Versions
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Documents
29 official files
Seletuskirja lisa 3
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Seletuskirja lisa 3
docx · ET · 8 March 2018
Seletuskirja lisa 2
docx · ET · 8 March 2018
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Seletuskirja lisa 1
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Seletuskiri
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Eelnõu
docx · ET · 8 March 2018
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Lõpptekst bdoc
bdoc · ET · 6 March 2017
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Lõpptekst
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Vabariigi Presidendi otsus bdoc
bdoc · ET · 6 March 2017
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Vabariigi Presidendi otsus
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Vastuvõetud seadus bdoc
bdoc · ET · 22 February 2017
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Kaaskiri Vabariigi Presidendile
pdf · ET · 22 February 2017
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Vastuvõetud seadus
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Eelnõu
docx · ET · 20 February 2017
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Eelnõu
docx · ET · 13 February 2017
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Muudatusettepanekute loetelu
docx · ET · 13 February 2017
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Seletuskiri
docx · ET · 13 February 2017
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EIS teade
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Seletuskirja lisa 3 (kooskõlastustabel) pdf
pdf · ET · 12 September 2016
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Seletuskirja lisa 2 (rakendusaktide kavandid) pdf
pdf · ET · 12 September 2016
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docx · ET · 12 September 2016
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Seletuskirja lisa 1 (vastavustabel) pdf
pdf · ET · 12 September 2016
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Seletuskirja lisa 1 (vastavustabel) docx
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Seletuskiri pdf
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Seletuskiri docx
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Kaaskiri
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Eelnõu pdf
pdf · ET · 12 September 2016
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Eelnõu docx
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Algtekstid bdoc
bdoc · ET · 12 September 2016
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Sponsors
- Viktor Vassiljev · 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 · Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seaduse ning riigilõivuseaduse muutmise seadus · 278 · EE
- Identifier matchPROJECTS_FROM
Same estonia record 24a5fb77-3977-4934-b74f-4fa7ef49a7e9 projected from PoliticalRepo EE row.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.riigikogu.ee/tegevus/eelnoud/24a5fb77-3977-4934-b74f-4fa7ef49a7e9/
- Open data entity: https://api.riigikogu.ee/api/volumes/24a5fb77-3977-4934-b74f-4fa7ef49a7e9
- estonia · 24a5fb77-3977-4934-b74f-4fa7ef49a7e9 · source updated 22 February 2017