Αποτελέσματα Αναζήτησης
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
The definition of a pharmacovigilance system is provided in Article 1 of Directive 2001/83/EC as a system used by the marketing authorisa tion holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products
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
Guideline on good pharmacovigilance practices (GVP) Module IX Addendum I Methodological – aspects of signal detection from spontaneous reports of suspected adverse reactions
With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency.
The basic legislation is supported by a series of guidelines that are also published in the following volumes of "The rules governing medicinal products in the European Union": Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use; Volume 3 - Scientific guidelines for medicinal products for human use
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).
