adverse reaction
as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6…, Article 1, point (11)
A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
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Also defined in
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(1)
set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply - Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws… 32001L0020, Article 2, point (n)
all untoward and unintended responses to an investigational medicinal product related to any dose administered;