What is Volume 9A in pharmacovigilance?
Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
What is Part III of Volume 9A?
Volume 9A is presented in four parts: -Part I deals with Guidelines for Marketing Authorisation Holders; -Part II deals with Guidelines for Competent Authorities and the Agency; -Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EU; and -Part IV provides Guidelines on …
Which volume brings together general guidance on the requirement Procedure roles and activities in the field of pharmacovigilance?
Volume 9A
Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the …
What is EudraVigilance database?
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). better product information for medicines authorised in the EEA.
Are there any guidelines for pharmacovigilance in the EU?
New legislation for pharmacovigilance appl ies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pha rmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.
What are the pharmacovigilance guidelines for EudraLex?
EudraLex – Volume 9 – Pharmacovigilance guidelines. Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use. Such guidelines are drawn up by the European Commission in consultation with the European Medicines Agency,…
Is the Pharmacovigilance guidance 2309 / 93 required to include?
2309/93 includes the same requirement. This guidance is required to include technical requirements for the electronic exchange of pharmacovigilance information in accordance with internationally agreed formats. In addition, the Commission is also required to publish a reference to an internationally agreed medical terminology.
Which is the best definition of Pharmacovigilance ( PV )?
According to the definition of the World Health Organization (WHO), Pharmacovigilance (PV) is “the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problems”.