Stoimenova A, B Kirilov, St. Gueorguiev, E. Petkova-Gueorguieva, S. Ognianov. Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings. Folia medica. March 2020; 62 (1): 165-171.
Петрова Г. и кол., Социална фармация и фармацевтично законодателство, Инфофарма, 2017
Гетов И, Е. Насева, Х. Лебанова, Е. Григоров. Основи на фармакоепидемиологията. МУ-София, ЕкоПринт, София, 2013 г., с.203. ISBN 978-954-92284-9-6
Ghalamkarpour A., Marketing authorization procedures in the European Union – making the right choice, Life science, 33/December 2009
From laboratory to patient: the journey of a medicine assessed by EMA, EMA/103813/2018 Rev. 1, 2019; https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf
Human medicines highlights 2018, EMA/790649/2018, 2018; https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2018_en.pdf
Reflection paper on chemical structure and properties criteria to be considered for the evaluation of new active substance status of chemical substances, EMA/CHMP/QWP/104223/2015, 17 December 2015; https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-chemical-structure-properties-criteria-be-considered-evaluation-new-active_en-0.pdf
Assessment report Encyzix, EMA/88321/2018, 25 January 2018; https://www.ema.europa.eu/en/documents/assessment-report/encyzix-epar-public-assessment-report_en.pdf
Assessment report Dexxience, EMA/548301/2018, 26 July 2018; https://www.ema.europa.eu/en/documents/assessment-report/dexxience-epar-refusal-public-assessment-report_.pdf
Assessment report Eladynos, EMA/CHMP/581111/2018, 26 July 2018; https://www.ema.europa.eu/en/documents/assessment-report/eladynos-epar-refusal-public-assessment-report_en.pdf
Assessment report Alsitek, EMA/406203/2018, 18 April 2018; https://www.ema.europa.eu/en/documents/assessment-report/alsitek-epar-refusal-public-assessment-report_en.pdf
Assessment report Exondys, EMA/691796/2018, 20 September 2018; https://www.ema.europa.eu/en/documents/assessment-report/exondys-epar-refusal-public-assessment-report_en.pdf
Human medicines highlights 2019, https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2019_en.pdf
Questions and answers on generic medicines, EMA/393905/2006 Rev. 2, 22 November 2012, https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf
Assessment report Cabazitaxel Teva, EMA/280661/2019, 26 April 2019, https://www.ema.europa.eu/en/documents/assessment-report/cabazitaxel-teva-epar-refusal-public-assessment-report_en.pdf
Assessment report Doxolipad, EMA/398153/2019, 29 May 2019, https://www.ema.europa.eu/en/documents/assessment-report/doxolipad-epar-refusal-public-assessment-report_en.pdf
Refusal of marketing authorization for Hopveus, EMA/232257/2020, EMEA/H/C/004962, 30 April 2020, https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-hopveus-sodium-oxybate_en-0.pdf
Assessment report Vanflyta, EMA/CHMP/602286/2019, 17 October 2019, https://www.ema.europa.eu/en/documents/assessment-report/vanflyta-epar-refusal-public-assessment-report_en.pdf