1 The administration of the product to the clinical
trial subject requires an approval under special regulations for gene
therapy only.
Figure 1: Consultation process with environmental competent authorities
with respect to environmental risk assessment for medicinal products for
human use during assessment of marketing authorisation applications
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3. Commission Directive 2009/120/EC of 14 September 2009 Amending
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5. Directive 2009/41/EC of the European Parliament and of the Council of
6 May 2009 on the contained use of genetically modified micro-organisms
(Recast)Text with EEA relevance. :23.
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Council of 12 March 2001 on the Deliberate Release into the Environment
of Genetically Modified Organisms and Repealing Council Directive
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10. 2002/813/EC: Council Decision of 3 October 2002 Establishing,
Pursuant to Directive 2001/18/EC of the European Parliament and of the
Council, the Summary Notification Information Format for Notifications
Concerning the Deliberate Release into the Environment of Genetically
Modified Organisms for Purposes Other than for Placing on the Market .
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http://data.europa.eu/eli/dec/2002/813/oj/eng
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12. Regulation (EU) No 536/2014 of the European Parliament and of
the Council of 16 April 2014 on Clinical Trials on Medicinal Products
for Human Use, and Repealing Directive 2001/20/EC Text with EEA
Relevance . Vol 158.; 2014. Accessed June 16, 2020.
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frequently asked questions. Accessed June 16, 2020.
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14. Common application form for viral vectors contained in
investigational medicinal products for human use. Accessed June 11,
2020.
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/vvs_caf_en.pdf
15. Common application form for investigational medicinal products for
human use that contain or consist of AAV vectors. Accessed June 11,
2020.
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_caf_en.pdf
16. Common Application form for clinical research with human cells
genetically modified by means of retro/lentiviral vectors. Accessed June
11, 2020.
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/gmcells_caf_en.pdf
17. Good Practice on the assessment of GMO related aspects in the
context of clinical trials with AAV clinical vectors. Accessed June 11,
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https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_gp_en.pdf
18. Good Practice on the assessment of GMO-related aspects in the
context of clinical trials with human cells genetically modified by
means of retro/lentiviral vectors. Accessed June 16, 2020.
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the Environmental Risk Assessment of Gene Therapy Medicinal Products.
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Published online 2008:14.
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21. European Medicines Agency. EMA
standard-operating-procedure-consultation-environmental-competent-authorities-genetically-modified_en.pdf.
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22. European Commission. Press release: Coronavirus: Commission unveils
EU vaccines strategy. Published June 17, 2020. Accessed June 17, 2020.
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