What is volume 9B pharmacovigilance?
What is volume 9B pharmacovigilance?
Volume 9B – Pharmacovigilance for Medicinal Products for Veterinary Use. Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use (Volume 9B – Version October 2011).
What is 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 part lll 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 …
How does EudraVigilance work?
EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.
What is Evctm?
The EudraVigilance Clinical Trial Module (EVCTM) to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC.
Where can I find guidance on Veterinary pharmacovigilance?
The main body of guidance on veterinary pharmacovigilance can be found in Volume 9B of The Rules Governing Medicinal Products in the European Union (EU): Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.
When was pharmacovigilance guidance for Human Medicinal Products published?
In the past the European Commission also published pharmacovigilance guidance for human medicinal products (Volume 9A). The most recent of this guidance documents dates from September 2008: Pharmacovigilance for medicinal products for human use.
What do you need to know about pharmacovigilance system?
Requirements for a detailed description of the pharmacovigilance system and how the information should be presented in a MAA are available in the guidance document below:
What is the Vich guidance on Pharmacovigilance?
For veterinary international conference on harmonisation (VICH) guidance on pharmacovigilance see Veterinary International Conference on Harmonisation (VICH). A pharmacovigilance system enables the collection, monitoring, assessment and evaluation of information related to adverse events.