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2. No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official J Eur Commun L158:1–76
3. Gøtzsche P (2012) Deficiencies in proposed new EU regulation of clinical trials. BMJ. doi:
10.1136/bmj.e8522
4. European Commission (2012) Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf
. Accessed 9 May 2017
5. NHS European Office (2014) The new EU Clinical Trials Regulation: how NHS research and patients will benefit.
http://www.nhsconfed.org/resources/2014/09/the-new-eu-clinical-trials-regulation-how-nhs-research-and-patients-will-benefit
. Accessed 9 May 2017