Leit í EES-gagnagrunni
Commission Regulation (EU) 2024/848 of 14 March 2024 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2024
Commission Delegated Directive (EU) .../… amending Directive 2010/63/EU of the European Parliament and of the Council as regards the requirements for establishments and for the care and accommodation of animals, and as regards the methods of killing animals
Commission Delegated Regulation (EU) …/... amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use
Commission Delegated Regulation (EU) …/... amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of the drug precursor Isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (IMDPAM) and other substances in the list of scheduled substances
D095075/01
Commission Implementing Regulation (EU) 2024/878 of 21 March 2024 adopting uniform rules on the size of small immediate packaging units of veterinary medicinal products as referred to in Article 12 of Regulation (EU) 2019/6 of the European Parliament and of the Council
D095073/01
Commission Implementing Regulation (EU) 2024/860 of 18 March 2024 amending Regulation (EU) No 37/2010 as regards the substance 17β-oestradiol
D095074/01
Commission Implementing Regulation (EU) 2024/875 of 21 March 2024 adopting a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council
D095325/01
Commission Implementing Regulation (EU) 2024/916 of 26 March 2024 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
D093445/02
Commission Implementing Regulation (EU) 2024/859 of 18 March 2024 amending Regulation (EU) No 37/2010 as regards the classification of the substance sodium salicylate with respect to its maximum residue limit in foodstuffs of animal origin
C(2024)0661
Commission Delegated Regulation (EU) 2024/1159 of 7 February 2024 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by laying down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals
Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
Commission Implementing Decision (EU) 2023/2484 of 9 November 2023 amending Implementing Decision 2012/715/EU as regards the inclusion of Taiwan in the list of third countries established by that Decision
D091027/02
Commission Implementing Regulation (EU) 2023/2194 of 19 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin
D091026/02
Commission Implementing Regulation (EU) 2023/2203 of 20 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance rafoxanide with respect to its maximum residue limit in foodstuffs of animal origin
C(2023)4568
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/2197 frá 10. júlí 2023 um breytingu á reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar úthlutun einkvæmra tækjaauðkenninga fyrir snertilinsur
C(2023)4261
Commission Delegated Regulation (EU) 2023/1766 of 29 June 2023 amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/1766 frá 29. júní 2023 um breytingu á reglugerð Evrópuþingsins og ráðsins (ESB) nr. 658/2014 að því er varðar leiðréttingu á gjöldum, með tilliti til verðbólgu, sem greiða ber til Lyfjastofnunar Evrópu vegna framkvæmdar á lyfjagátarstarfsemi að því er varðar mannalyf
Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2023/1194 frá 20. júní 2023 um breytingu á framkvæmdarreglugerð (ESB) 2022/2346 að því er varðar umbreytingarákvæði vegna tiltekinna vara án ætlaðs læknisfræðilegs tilgangs sem eru tilgreindar í XVI. viðauka við reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745
Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2023/981 of 17 May 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance praziquantel with respect to its maximum residue limit in foodstuffs of animal origin
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Commission Implementing Decision .../... on the authorisation to place on the Union market in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council certain medical devices manufactured by Maquet Cardiopulmonary GmbH
Commission Regulation (EU) 2023/699 of 29 March 2023 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2023
Reglugerð framkvæmdastjórnarinnar (ESB) 2023/699 frá 29. mars 2023 um breytingu á reglugerð ráðsins (EB) nr. 297/95 að því er varðar leiðréttingu á gjöldum til Lyfjastofnunar Evrópu með tilliti til verðbólgu, sem tekur gildi frá og með 1. apríl 2023
COM(2023) 122
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC