4 TEU, arts 13–19; TFEU, arts 223–309.
14 For an introduction to Eurozone law, see Hinarejos, A ‘Economic and Monetary Union’ in C Barnard and S Peers (eds), European Union Law (OUP 2020), 583–611; on how Eurozone law works in practice, see, for example H Schepel, ‘The Bank, the Bond, and the Bailout: On the Legal Construction of Market Discipline in the Eurozone’ (2017) 44 Journal of Law and Society 79–98.
19 TFEU, art 9; see T Hervey, ‘EU health law’ in C Barnard and S Peers (eds) European Union Law (OUP 2020).
21 Case 26/62 Van Gend en Loos  ECR 1, EU:C:1963:1 (European Court of Justice) ( 5 February 1963).
51 Such as for the adoption of delegated acts, TFEU, art 290, and implementing acts, art 291.
53 See, seminally, C Harlow, Accountability in the European Union (OUP 2002); D Curtin, The Executive Power of the European Union: Law, Practices and the Living Constitution (OUP 2009).
54 See TFEU, arts 263, art 267(b); for further information, see, eg, A Arnull, ‘Judicial Review in the European Union’ in D Chalmers and A Arnull (eds), The Oxford Handbook of European Union Law (OUP 2015); individual applicants have very limited locus standi to bring judicial review claims in EU law, see Case 25/62, Plaumann & Co v Commission ECLI:EU:C:1963:17 (European Court of Justice) (15 July 1963); this has been the subject of criticism in the context of EU pharmaceutical law, see, eg, J Abraham and C Davis, ‘Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy’ in M Flear et al (eds), European Law and New Health Technologies (OUP 2013); T Hervey, ‘EU Health Law’ in C Barnard and S Peers (eds) European Union Law (OUP 2020).
64 For an in-depth analysis of the roles of soft law in the EU, see L Senden, Soft Law in European Community Law: Its Relationship to Legislation (Wolf Legal Publishers 2003); O Stefan, M Avbelj, M Eliantonio, et al, ‘EU Soft Law in the EU Legal Order: A Literature Review’ King's College London Law School Research Paper (4 March 2019).
84 Case 9/56 Meroni No 1 [1957–58] ECLI:EU:C:1958:7 (European Court of Justice) (13 June 1958).
85 See, in general, P Craig, EU Administrative Law (OUP 2019); and for a discussion of this process in the context of the EU’s evolving public health competence, see T Hervey, ‘The Role of the European Court of Justice in the Europeanization of Communicable Disease Control: Driver or Irrelevance?’ (2012) 37 Journal of Health Politics, Policy and Law 977–1000.
106 Case T-710/21 R Roos and ors v Parliament ECLI:EU:T:2021:838 (General Court, Order of the President of the Tribunal) (3 November 2021); and Case T-722/21 D’Amato and ors v Parliament (unreported).
109 Some meetings are in-person, others are held virtually, see European Council, ‘Meeting Calendar’ (accessed 14 January 2022).
119 C Popotas, ‘COVID-19 and the Courts. The case of the CJEU’ (2020) 2/3(7) Access to Justice in Eastern Europe 160–171; the CJEU was asked to consider whether Italian Covid-19 arrangements inter alia affecting the Italian judicial system breach EU law obligations, see Case C-220/20 XX v OO ECLI:EU:C:2020:1022 (Court of Justice, Order of the Court (Tenth Chamber)) (10 December 2020), but rejected the claim as manifestly inadmissible.
123 See, eg, Case T-74/00 Artegodan ECLI:EU:T:2002:283 (Court of First Instance) (26 November 2002); Case T-13/99 Pfizer ECLI:EU:T:2002:209 (Court of First Instance) (11 September 2002).
126 For a definition, see EUR-Lex, ‘Acquis’ (accessed 30 January 2022).
129 See S L Greer (ed), The Politics of Communicable Disease Control in Europe (2012) 37(6) Special issue of the Journal of Health Politics, Policy, and Law.
141 An early example is J Braithwaite, Corporate Crime in the Pharmaceutical Industry (Routledge & Kegan Paul 1984); for discussion of the European Union dimensions, see T Hervey and J McHale, European Union Health Law: Themes and Implications (CUP 2015), 319–320, 322–347, 508; for discussion of a case study involving the EMA and the European Ombudsman (Part III.G), see P C Gøtzsche and A W Jørgensen, ‘Opening Up Data at the European Medicines Agency’ British Medical Journal (2011).
207 Commission Proposal COM(2021) 130 final, iart 15, foresaw the suspension of the digital certificate measure after the end of the Covid-19 pandemic, but also a possibility to reactivate it where ‘the Director-General of the World Health Organization declares a public health emergency of international concern in relation to SARS-CoV-2, a variant thereof, or similar infectious diseases with epidemic potential’.
214 From the rich discussion see eg L Bialasewicz and A Alemanno, ‘Symposium on COVID-19 Certificates’ European Journal of Risk Regulation (forthcoming); A Alemanno and L Bialasewicz, ‘Certifying Health - The Unequal Legal Geographies of COVID-19 Certificates’ European Journal of Risk Regulation (June 2021); L Bialasiewicz and A Alemanno, ‘The dangerous illusions of an EU “vaccine passport”’ Open Democracy (Online, 9 March 2021); L Taylor, S Milan, M Veale, et al, ‘Immunity Certification Theater’, Lex-Atlas: Covid-19 (Online, 14 May 2021); ‘EU vaccine passport: An ethical and legal minefield?’ Deutsche Welle (Online, 2 March 2021); on some of the legal issues in Germany, see, eg A Klafki, ‘Der Immunitätsausweis und der Weg zurück in ein freiheitliches Leben’, VerfassungsBlog (Online, 4 May 2020); on some of the practical, as well as legal and ethical issues, see, eg, H T Greely, ‘COVID-19 immunity certificates: science, ethics, policy, and law’ (2020) 7(1) Journal of Law and the Biosciences; or M Hall and D Studdert, ‘“Vaccine Passport” Certification — Policy and Ethical Considerations’ New England Journal of Medicine (2021).
215 Action brought on 30 August 2021: Abenante and ors v Council and Parliament Case T-527/21 (General Court, Order from the President of the Court) (29 October 2021).
216 Abenante and ors v Council and Parliament Case T-527/21 (General Court, Order from the President of the Court) (29 October 2021).
270 The legal basis for EU measures is to be found in the approximation of laws provision: TFEU, art 114, in conjunction with art 168(4), which allows for EU legislative action in order to contribute to the achievement of public health objectives through ‘[m]easures setting high standards of quality and safety for medicinal products and devices for medical use’.
271 For overviews of the pharmaceutical regulatory framework, see E Jackson, Law and the Regulation of Medicines (OUP 2012); S Shorthose, Guide to European Pharmaceutical Regulatory Law (Alphen aan den Rijn 2017); M Manely and M Vickers (eds), Navigating European Pharmaceutical Law (OUP 2015).
284 Cases T-96/21, T-136/21, T-165/21 and T-267/21 Amort and ors v Commission (General Court) (action brought on 16 February 2021).
286 Agreiter and ors v Commission Case T-632/21 (General Court) (action brought on 1 October 2021); Faller and ors v Commission Case T-464/21 (General Court) (action brought on 30 July 2021).
345 Commission v Slovak Republic Case C-540/21 (Court of Justice) (action brought on 27 August 2021).