unexpected adverse reaction
as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6…, Article 1, point (13)
An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.
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Also defined in
- 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 (p)
an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised investigational product or summary of product characteristics for an authorised product).