6533b830fe1ef96bd1297956
RESEARCH PRODUCT
New European legislation on pharmacovigilance
Gabriel Doménechsubject
Human useHealth PolicyPolitical sciencePharmacovigilanceLegislationContext (language use)Subject (documents)Public administrationDirectivePharmacology Toxicology and Pharmaceutics (miscellaneous)description
TheEuropeanParliament and theCouncil of the EuropeanUnion have recently adoptedRegulation (EU) No 1235/20101 and Directive 2010/84/EU2 concerning the pharmacovigilance of medicinal products for human use. These and other European institutions have been laying down rules on the subject for decades, but this is the first time they have enacted legislation specifically and (almost) exclusively regulating pharmacovigilance. This paper analyzes the context, causes, objectives, key points and challenges of the new legislation.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2011-01-01 | Pharmaceuticals, Policy and Law |