COM(2025) 1022
Proposal for a Regulation of the European Parliament and of the Council .../... on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Þýðing EES-gerðar birtist hér á íslensku við upptöku í EES-samninginn og birtingu í EES-viðbæti.
Gerð ekki til á íslensku
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Tillaga sem gæti verið EES-tæk
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Gerð í skoðun hjá EES-EFTA ríkjunum
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Drög að ákvörðun sameiginlegu nefndarinnar í skoðun
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Ákvörðun sameiginlegu nefndarinnar samþykkt en hefur ekki öðlast gildi
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Tekin upp í EES-samninginn og í gildi
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Tekin upp í EES-samninginn en ekki lengur í gildi
Staða og svið tillögu/gerðar
| Staða tillögu/gerðar | Tillaga ESB sem er merkt EES-tæk |
|---|---|
| Svið (EES-samningur, viðauki) | 02 Tæknilegar reglugerðir, staðlar, prófanir og vottun, 02.13 Lyf |
Staða innan stjórnsýslunnar
| Stofnun hefur lokið yfirferð | Á ekki við |
|---|---|
| Þörf á aðlögun í ákvörðun sameiginlegu nefndarinnar | Ekki þörf á aðlögun |
| Fagráðuneyti hefur lokið vinnu við upplýsingablað og samþykkir drög að ákvörðun sameiginlegu nefndarinnar | Nei |
| Alþingi hefur lokið mati sínu | Nei |
| Utanríkisráðuneyti hefur veitt samþykki fyrir því að drög að ákvörðun sameiginlegu nefndarinnar séu send til ESB | Nei |
Innleiðing
| Innleiðing | Engar laga- eða reglugerðabreytingar |
|---|---|
| Staða innleiðingarvinnu | Innleiðing ekki hafin |
Samráð
| Samráð | Nei |
|---|
Áhrif
| Áætlaður kostnaður hins opinbera | Ekki vitað |
|---|
Ábyrgðaraðilar
| Ábyrgt ráðuneyti | Heilbrigðisráðuneytið |
|---|
Vinnslustig (pipeline stage)
| COM numer | COM(2025) 1022 |
|---|---|
| Dagsetning tillögu ESB | |
| Dagsetning tillögu |
Leggur til breytingar á (Proposes to amend)
| 32024R1938 | Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC | Gerð í skoðun hjá EES EFTA-ríkjunum |
| 32024R0795 | Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241 | Gerð í skoðun hjá EES EFTA-ríkjunum |
| 32019R0006 | Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC | Tekin upp í EES-samninginn og í gildi |
| 32014R0536 | Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC | Tekin upp í EES-samninginn og í gildi |
| 32007R1394 | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 | Tekin upp í EES-samninginn og í gildi |
Breytt af (Modified by)
| SEC(2025) 1055 52025SC1055 |
work related to work | ||
| COM(2025) 1022 52025PC1022(01) |
influences | Proposal for a Regulation of the European Parliament and of the Council .../... on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) | Tillaga sem gæti verið EES-tæk |
Breytir (Modifies)
| COM(2025) 1031 52025PC1031 |
work related to work | Proposal for a Directive of the European Parliament and of the Council .../... amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs | Tillaga sem gæti verið EES-tæk |
| COM(2025) 1023 52025PC1023 |
work related to work | Proposal for a Regulation of the European Parliament and of the Council .../... amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I | Tillaga sem gæti verið EES-tæk |
| COM(2025) 1024 52025DC1024 |
work related to work | ||
| 32024R1938 | proposes to amend | Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC | Gerð í skoðun hjá EES EFTA-ríkjunum |
| 32024R0795 | proposes to amend | Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241 | Gerð í skoðun hjá EES EFTA-ríkjunum |