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1

Agency, Medicines Control. European Union directive 2001/20/EC on good clinical practice in clinical trials: Consultation on the UK's proposed implementing regulations. Medicines Control Agency, 2003.

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2

Northern Ireland. Department of Agriculture and Rural Development. Public consultation environmental report: (as required under European Directive 2001/42/EC) : the Draft Northern Ireland Development Programme 2007-2013. Dept. of Agriculture and Rural Development, 2006.

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Watson, Jenna M. Seeing the forest for the trees: Best practice guide for implementation of European directive 2001/42/EC in the UK forestry sector. Oxford Brookes University, 2002.

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4

Environment, Northern Ireland Department of the. EC Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms: Department of the Environment's plans for transposition of the directive in Northern Ireland : a consultation paper. DOE, 2001.

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Great Britain. Maritime and Coastguard Agency., ed. Safe loading and unloading of bulk carriers 2003: Implementing EC Directive 2001/96/EC (establishing harmonised requirements and procedures for the safe loading and unloading of bulk carriers) : new provisions apply from 1 March 2004. TSO, 2003.

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6

Great Britain. Office of the Deputy Prime Minister., Wales Welsh Assembly Government, Scotland Scottish Executive, and Great Britain. Department of the Environment for Northern Ireland., eds. A draft practical guide to the Strategic Environmental Assessment Directive: Proposals by ODPM, the Scottish Executive, the Welsh Assembly Government and the Northern Ireland Department of the Environment for practical guidance on applying European Directive 2001/42/EC 'on the assessment of the effects of certain plans and programmes on the environment'. Office of the Deputy Prime Minister, 2004.

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7

Scrip's essential EEC texts.: Directive 2001/83/EC. Brookwood Medical Publications, 2002.

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8

The Pocket Guide to the EU Directives for Clinical Research: Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC, GMP Directive 2003/94/EC. Institute of Clinical Research, 2009.

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9

The Fundamental Guidelines for Clinical Research: ICH GCP 1996, Declaration of Helsinki 2004, EU Directive 2001/20/EC, EU Directive 2005/28/EC. Institute of Clinical Research, 2005.

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10

Spence, Michael, and Ansgar Ohly. The Law of Comparative Advertising: Directive 97/55/Ec in the United Kingdom and Germany. Hart Publishing (UK), 1999.

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11

I, Bernard Barana. Electricity in the Eu. the Guarantee of Origin According to Directive 2001/77/EC. GRIN Verlag GmbH, 2016.

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12

Römer, Barbara. 2001/20/Ec - a European Directive?: Major Regulatory Objectives for a Real Harmonisation in Europe. Tectum Verlag, 2011.

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13

Implementation of SEA Directive (2001/42/EC): Assessment of the effects of certain plans and programmes on the environment. Department of the Environment, Heritage and Local Government, 2004.

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14

Smedley, Julia, Finlay Dick, and Steven Sadhra. Legislation related to occupational health records. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199651627.003.0027.

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Data Protection Act 1998 578Access to Medical Reports Act 1988 580Freedom of Information Act 2000 582The Data Protection Act 1998 came into force in 2001 and governs the collection, holding, use or release of data on individuals as required by EC Directive 95/46/EC. It sets out principles of good data handling (‘the eight principles’) and confers several rights on individuals. This Act replaces the Data Protection Act 1984 and the Access to Health Records Act 1990, although the latter still applies to access to the medical records of dead people....
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15

Moss QC, Gabriel, Bob Wessels, and Matthias Haentjens. EU Banking and Insurance Insolvency. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198759393.001.0001.

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Following the chaotic effects of the global financial crisis on European financial markets, the legislative regime introduced by the European Union (EU) represents a dramatic new approach to bank insolvency law, and will have a profound effect on the way banks function. The second edition of EU Banking and Insurance Insolvency evaluates these important developments and their implications for the Eurozone countries. A comprehensive general introduction sets out the EU insolvency law framework and the principles which govern financial institutions. The book provides detailed commentary on the Ba
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16

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial supplies: investigational medicinal products (IMPs). Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0017.

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This chapter describes the procedures and records associated with accountability of investigational and non-investigational medicinal products (IMP and NIMP) used in clinical trials, to show that the drug has been labelled according to the regulations, stored in conditions to keep it stable, prepared and administered to the correct subjects in accordance with the protocol, has been fully accounted for and destroyed if unused. Manufacture of IMP is discussed together with methods of blinding. The role of the Qualified person (QP) is reviewed. The need for study drug accountability is discussed
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