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Volume 9 of "The rules governing medicinal products in the European Union" contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
- Die Europäische Kommission
Volume 9 is presented in four parts: Part I deals with...
- Die Europäische Kommission
Volume 9 is presented in four parts: Part I deals with pharmacovigilance of medicinal products for human use. Part II addresses pharmacovigilance of veterinary medicinal products Part III provides general information on EU electronic exchange of pharmacovigilance data.
VOLUME 9A . of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use –
the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for Medicinal Products for Human Use. This Q&A document provides conventions for the harmonised interpretation of EudraLex - Volume 9A.
Volume 9 of "The rules governing medicinal products in the European Union" contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use. In the past the European Commission also published pharmacovigilance guidance for human medicinal products (Volume 9A).
Until July 2012, the European Commission drew up pharmacovigilance guidelines in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council, known as volume 9A.
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.
