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1, Note for Guidance on Good Clinical Practice (E6). Effective date: 17th January 1997.highlighting point 04. Investigator gcp1.pdf

2. Clinical trials in minors. Directive 2001/20/EC Article 4

3. EU GCP Directive 2005/28/EC. 3.dir_2005_28_en.pdf

4. Helyes Klinikai Gyakorlat. (Good Clinical Practice) gcp_ogyi.pdf  

5. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric population.

ICH11--CHMP/ICH/2711/99 5.wc500002926.pdf

6. Ethical Consideration for Clinical Trials on Medicinal Products conducted with the paediatric population ethical_considerations_en.pdf

7. 235/2009. (X.20.) Korm. Rendelet 235.2009.docx

8. 35/2005 (Vlll.26.) EüM rendelet 35.2005.docx

9. Regulations on paediatric medicinal products.

Regulations (EC) No 1901/2006 9.reg_2006_1901_en.pdf

10. Regulations on advanced therapy medicinal products.

Regulations (EC) No 1394/2007 10.reg_1394_2007.pdf

11. WHO Global campaign"Make medicines child size".