Parallel, divergent or drifting? Regulating healthcare products in a post-Brexit UK

Legislation

UK

• Health and Social Care Act, (2012). https://www.legislation.gov.uk/ukpga/2012/7/section/75/enacted
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• Procurement Bill [HL], Grand Committee, (26 October 2022). https://bills.parliament.uk/publications/48269/documents/2396
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• The Public Contracts Regulations, Statutory Instrument n.102, (2015). https://www.legislation.gov.uk/uksi/2015/102/mad
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• The National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations, Statutory Instrument 500, (2013). https://www.legislation.gov.uk/uksi/2013/500/made
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• Health and Care Act, (2022). https://www.legislation.gov.uk/ukpga/2022/31/enacted
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• Retained EU Law (Revocation and Reform) Bill (2022). https://bills.parliament.uk/bills/3340/publications
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EU

• Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC Text with EEA relevance. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014L0024
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• Directive 93/42/EEC of 14 June 1993 concerning medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2016.119.01.0001.01.ENG&toc=OJ%3AL%3A2016%3A119%3ATOC
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• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A31998L0079
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• Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32011L0062
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• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505
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• Regulation (EU) 2017.746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. https://eur-lex.europa.eu/eli/reg/2017/746/oj
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• Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2016.119.01.0001.01.ENG&toc=OJ%3AL%3A2016%3A119%3ATOC
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• Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31989L0105
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• Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross border healthcare. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:en:PDF
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• European Union (Eur-Lex, 2021) Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282
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