View source for Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)

{{ReferenceData
|has_document=Document:GBR Directive 2001/20/EC 04-Apr-2001
|module=5
|unit=5.1.4
|scope=HM
|doc_part=Article 2
(p)
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00331-Une-irk ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00034-Inv-Bro ++ TAG-00067-Exp-war
|tags_display=[[Glossary:TAG-00331-Une-irk|Unexpected adverse reaction]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00034-Inv-Bro|Investigator's brochure]], [[Glossary:TAG-00067-Exp-war|Expectedness]]
|comment=Definition of unexpected adverse reaction (EU directive)
|content=(p)‘unexpected adverse reaction’: 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).
}}