Search Results

Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council (Text with EEA relevance)

C/2021/5063

OJ L 275, 31/07/2021, p. 1–2 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 275, 31/07/2021, p. 1–2

Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use (Text with EEA relevance)

C/2022/6240

OJ L 294, 15/11/2022, p. 5–7 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 294, 15/11/2022, p. 5–7

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

C/2022/30

OJ L 5, 10/01/2022, p. 14–25 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 5, 10/01/2022, p. 14–25

Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance. )

C/2017/3368

OJ L 238, 16/09/2017, p. 12–21 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 238, 16/09/2017, p. 12–21

Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council (Text with EEA relevance. )

C/2017/1812

OJ L 80, 25/03/2017, p. 7–13 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 80, 25/03/2017, p. 7–13

European Parliament resolution of 14 February 2017 on promoting gender equality in mental health and clinical research (2016/2096(INI))

OJ C 252, 18/07/2018, p. 99–112 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 252, 18/07/2018, p. 99–112

European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer — towards a comprehensive and coordinated strategy (2020/2267(INI))

OJ C 342, 06/09/2022, p. 109–147 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
OJ C 342, 06/09/2022, p. 98–136 (GA)

OJ C 342, 06/09/2022, p. 109–147

European Parliament resolution of 24 November 2021 on a pharmaceutical strategy for Europe (2021/2013(INI))

OJ C 224, 08/06/2022, p. 47–68 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 224, 08/06/2022, p. 47–68

European Parliament resolution of 17 September 2020 on the shortage of medicines — how to address an emerging problem (2020/2071(INI))

OJ C 385, 22/09/2021, p. 83–103 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 385, 22/09/2021, p. 83–103

COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products